Westminster Prostate Care

2012-02-14T09:49:00.000-08:00

Thought you might like to see these!!! Comments made in the year 1957:

"I'll tell you one thing, if things keep going the way they are, it's going to be impossible to buy a week's groceries for $20."

"Have you seen the new cars coming out next year? It won't be long before $5000 will only buy a used one."

Johns Hopkins Update on Cancer Treatment

2011-12-20T12:57:00.000-08:00

Johns Hopkins Update - Very Good Article

AFTER YEARS OF TELLING PEOPLE CHEMOTHERAPY
IS THE ONLY WAY TO TRY ('TRY', BEING THE KEY WORD) TO ELIMINATE CANCER,JOHNS HOPKINS IS FINALLY STARTING TO TELL YOU THERE IS AN ALTERNATIVE WAY .

Cancer Update from Johns Hopkins :

1. Every person has cancer cells in the body. These cancer
cells do not show up in the standard tests until they have
multiplied to a few billion. When doctors tell cancer patients
that there are no more cancer cells in their bodies after
treatment, it just means the tests are unable to detect the
cancer cells because they have not reached the detectable
size.

2. Cancer cells occur between 6 to more than 10 times in a
person's lifetime .

3. When the person's immune system is strong the cancer
cells will be destroyed and prevented from multiplying and
forming tumors.

4. When a person has cancer it indicates the person has
nutritional deficiencies. These could be due to genetic,
to environmental, food and lifestyle factors.

5. To overcome the multiple nutritional deficiencies, changing
diet and including supplements will strengthen the immune
system.

6. Chemotherapy involves poisoning the rapidly-growing
cancer cells and also destroys rapidly-growing healthy cells
in the bone marrow, gastrointestinal tract etc, and can
cause organ damage, like liver, kidneys, heart, lungs etc.

7. Radiation while destroying cancer cells also burns, scars
and damages healthy cells, tissues and organs.

8. Initial treatment with chemotherapy and radiation will often
reduce tumor size. However prolonged use of
chemotherapy and radiation do not result in more tumor
destruction.

9. When the body has too much toxic burden from
chemotherapy and radiation the immune system is either
compromised or destroyed, hence the person can succumb
to various kinds of infections and complications.

10. Chemotherapy and radiation can cause cancer cells to
mutate and become resistant and difficult to destroy.
Surgery can also cause cancer cells to spread to other
sites.

11. An effective way to battle cancer is to starve the cancer
cells by not feeding it with the foods it needs to multiply.

*CANCER CELLS FEED ON:

a. Sugar is a cancer-feeder. By cutting off sugar it cuts off
one important food supply to the cancer cells. Sugar
substitutes like NutraSweet, Equal, Spoonful, etc are made
with Aspartame and it is harmful. A better natural substitute
would be Manuka honey or molasses, but only in very small
amounts. Table salt has a chemical added to make it white in
color Better alternative is Bragg's aminos or sea salt.

b. Milk causes the body to produce mucus, especially in the
gastro-intestinal tract. Cancer feeds on mucus. By cutting
off milk and substituting with unsweetened soy milk cancer
cells are being starved.

c. Cancer cells thrive in an acid environment. A meat-based
diet is acidic and it is best to eat fish, and a little chicken
rather than beef or pork. Meat also contains livestock
antibiotics, growth hormones and parasites, which are all
harmful, especially to people with cancer.

d. A diet made of 80% fresh vegetables and juice, whole
grains, seeds, nuts and a little fruits help put the body into
an alkaline environment. About 20% can be from cooked
food including beans. Fresh vegetable juices provide live
enzymes that are easily absorbed and reach down to
cellular levels within 15 minutes to nourish and enhance
growth of healthy cells. To obtain live enzymes for building
healthy cells try and drink fresh vegetable juice (most
vegetables including bean sprouts) and eat some raw
vegetables 2 or 3 times a day. Enzymes are destroyed at
temperatures of 104 degrees F (40 degrees C).

e. Avoid coffee, tea, and chocolate, which have high
caffeine. Green tea is a better alternative and has cancer
fighting properties. Water-best to drink purified water, or
filtered, to avoid known toxins and heavy metals in tap
water. Distilled water is acidic, avoid it.

12. Meat protein is difficult to digest and requires a lot of
digestive enzymes. Undigested meat remaining in the
intestines becomes putrefied and leads to more toxic
buildup.

13. Cancer cell walls have a tough protein covering. By
refraining from or eating less meat it frees more enzymes
to attack the protein walls of cancer cells and allows the
body's killer cells to destroy the cancer cells.

14.. Some supplements build up the immune system
(IP6, Flor-ssence, Essiac, anti-oxidants, vitamins, minerals,
EFAs etc.) to enable the bodies own killer cells to destroy
cancer cells. Other supplements like vitamin E are known
to cause apoptosis, or programmed cell death, the body's
normal method of disposing of damaged, unwanted, or
unneeded cells.

15. Cancer is a disease of the mind, body, and spirit.
A proactive and positive spirit will help the cancer warrior
be a survivor. Anger, un-forgiveness and bitterness put
the body into a stressful and acidic environment. Learn to
have a loving and forgiving spirit. Learn to relax and enjoy
life.

16. Cancer cells cannot thrive in an oxygenated
environment. Exercising daily, and deep breathing help to
get more oxygen down to the cellular level. Oxygen
therapy is another means employed to destroy cancer
cells.

1. No plastic containers in micro.

2. No water bottles in freezer.

3. No plastic wrap in microwave.

Johns Hopkins has recently sent this out in its newsletters. This information is being circulated at Walter Reed Army Medical Center as well. Dioxin chemicals cause cancer, especially breast cancer. Dioxins are highly poisonous to the cells of our bodies. Don't freeze your plastic bottles with water in them as this releases dioxins from the plastic. Recently, Dr Edward Fujimoto, Wellness Program Manager at Castle Hospital, was on a TV program to explain this health hazard. He talked about dioxins and how bad they are for us. He said that we should not be heating our food in the microwave using plastic containers. This especially applies to foods that contain fat. He said that the combination of fat, high heat, and plastics releases dioxin into the food and ultimately into the cells of the body. Instead, he recommends using glass, such as Corning Ware, Pyrex or ceramic containers for heating food. You get the same results, only without the dioxin. So such things as TV dinners, instant ramen and soups, etc., should be removed from the container and heated in something else. Paper isn't bad but you don't know what is in the paper. It's just safer to use tempered glass, Corning Ware, etc. He reminded us that a while ago some of the fast food restaurants moved away from the foam containers to paper. The dioxin problem is one of the reasons.

Also, he pointed out that plastic wrap, such as Saran, is just as dangerous when placed over foods to be cooked in the microwave. As the food is nuked, the high heat causes poisonous toxins to actually melt out of the plastic wrap and drip into the food. Cover food with a paper towel instead.

FY 2012 DOD Funding for Prostate Cancer

2011-12-18T20:07:00.000-08:00

From: pcaroundtable-bounces@malecare.com [mailto:pcaroundtable-bounces@malecare.com] On Behalf Of Kevin Johnson
Sent: Friday, December 16, 2011 12:14 PM
To: PCa Roundtable
Subject: [Pcaroundtable] Approps - further analysis

Here is a little more information from an email I sent to my board this morning:
I just wanted to let you know that contained within the funding package that the House and Senate should pass tonight is $80 million for the Prostate Cancer Research Program at DOD. The PCRP was the only non-combat related stand alone program that maintained level funding from last year. The Medical Research Program which is a pot of money used to fund several smaller research programs was also level funded (at $50 million respectively).

Only 3 programs received increased funding over last year's funding level – Traumatic Brain Injury research, Orthopedic research and Gulf War Illness research.

All other programs were cut by 20% including Breast Cancer Research and Ovarian Cancer Research which are generally seen along with the PCRP as the main programs of the CDRMP because they've been around the longest.

Let me know if you have any questions.Kevin

Kevin S. Johnson

Sr. Vice President, Government Relations & Advocacy

ZERO – The Project to End Prostate Cancer

---------------------------------------------------------------------------

This

cardiovascular comorbidity is associated with treatment regret among men with recurrent prostate

2011-12-14T14:19:00.000-08:00

The "New" Prostate Cancer InfoLink is intended for informational purposes only. It is not engaged in rendering medical advice or professional services.
News and information provided on this site should not be used for diagnosing or treating any health problem or disease.
Copyright © 2008-11 Prostate Cancer International, Inc.Regret post-treatment in men with pre-existing cardiovascular disease
Posted on December 10, 2011 by Sitemaster
i 2 Votes

Another newly published paper, this time in the British Journal of Urology, addresses issues related to cardiovascular disease and the treatment of prostate cancer. However, in this case it is about the treatment of men who had an existing cardiovascular condition at the time of their initial treatment.

In this paper, Nguyen et al. sought to explore specifically whether cardiovascular comorbidity is associated with treatment regret among men with recurrent prostate cancer after first-line therapy. it has previously been demonstrated that treatment regret is associated with a lower level of educational attainment, non-White race, greater post-treatment declines in sexual function, and systemic symptoms.

Treatment regret can have an adverse impact on a patient’s overall outlook and has been associated with a poorer global quality of life. Understanding predictors of regret can help clinicians better counsel patients about their treatments so that later regret can be avoided. In previous studies, regret has been

The study was based on a retrospective analysis of data from 795 men enrolled in the Comprehensive, Observational, Multicenter, Prostate Adenocarcinoma (COMPARE) registry. All patinets had a biochemical recurrence at an average (median) of 5.5 years after prostatectomy (n = 410), external beam radiation therapy (n = 237), brachytherapy (n = 124) or primary androgen deprivation therapy (n = 24).
The authors were able to show that:
14.8 percent of the patient cohort reported regret.
Patients with pre-existing cardiovascular comorbidity were more likely to experience post-therapy bowel toxicity (P = 0.022).
The factors significantly associated with increased treatment regret were
Cardiovascular comorbidity (adjusted odds ratio [AOR] = 1.52)
Younger age (AOR = 0.97 per year increase in age)
Bowel toxicity post-treatment (AOR = 1.58)
The authors conclude that the patients with pre-existing cardiovascular comorbidities were > 50 percent more likely to experience treatment regret than men without cardiovascular comorbidity, and that these data suggest that men with pre-existing cardiovascular comorbidities give additional consideration to active surveillance as a first-line form of management for newly diagnosed prostate cancer.
A further discussion of this paper on the Reuters web site provides supplementary information. In that discussion, Dr. Timothy Showalter, a radiation oncologist at Jefferson Medical College in Philadelphia who was not involved in the research is quoted as stating that “We’ve known for a while that men with other medical problems, like heart disease, may get a smaller benefit from radiation or surgery.” He want on to say that this study represents “another piece of evidence that supports closely monitoring men with prostate cancer” as opposed to implementing immediate treatment.
As noted by Reuters, “The study doesn’t show why patients with heart problems had more second thoughts about their treatment.” One possibility noted by the study’s lead author is that “men dealing with other diseases may not be able to cope with the extra distress from cancer treatment.”

It is important to note that this study only addresses regret in men who had a biochemical recurrence after first-line treatment and not all patients receiving first-line treatment for prostate cancer. As Dr. Nguyen is also quoted as saying, “This study tells men who have other diseases that maybe they should take a step back and not treat the cancer right away.”

Fairfax County Prescription Drug Discounts

2011-12-10T15:11:00.001-08:00

Prescription Drug Discount Card Available to All Residents

Residents may be able to cut their prescription drug costs by almost half on average, thanks to a new, free discount card offered by Fairfax County through a partnership. This card will help the estimated 144,000-plus residents without health insurance, although it may offer savings to the insured too.

The county is making the card available because the number of uninsured has spiked in recent years. Their ranks have grown by 27 percent between 2009 and 2010, according to U.S. Census estimates. The latest figures show that 13.5 percent of residents lacked insurance last year.

There are several ways to get a Fairfax County Prescription Drug Discount Card:

Print a card at www.FairfaxRxDiscountCard.com.
Get a card at any participating pharmacy; supplies will be limited.
Look in the mail. In the next two weeks, they will be mailed to homes in areas with the highest concentration of uninsured residents.

On average, the card cuts the cost of a prescription by 45 percent, depending on the drug and amount bought. For brand-name drugs, discounts are estimated to be 10 to 20 percent, and 20 to 70 percent for generics. Based on use countywide, officials expect the card will produce a total savings of $280,000 per month.

Studies have shown that lack of insurance, economic hardship and drug costs cause many to forgo the medicines they need. This fall a nationwide survey by Consumer Reports found that 35 percent of people with low-incomes are skimping on their medicines, with:

percent not filling a prescription
percent taking an expired medicine
percent skipping a dose
percent splitting pills in half
percent sharing a prescription with someone else

Besides the uninsured, the discount card also may help insured residents anytime they must pay full price for a prescription because their plan doesn't cover a drug. The card cannot be used to reduce the cost of co-pays, co-insurance or deductibles.

Discounts are available for some pet medicines too. However, the drugs must be human medicines that can be taken by animals, and the prescription must be filled at a pharmacy, not a veterinarian's office.

Almost every pharmacy in the county accepts the card, plus 62,000 others across the nation. No enrollment or registration is needed to use it, and one card can be used for multiple people. To get discounts, just present the card at the pharmacy when buying medicine.

No personal or health information is collected when the card is used, and an individual's drug purchases are completely confidential. However, pharmacies will report the total types and amounts of drugs sold by discount in order for the county to track the total savings generated.

Fairfax County is offering the discount card through a partnership with ProAct, a pharmacy benefit management company. For information or help, call ProAct's help desk toll-free at 1-877-776-2285, TTY 711.

Help is available 24/7, and ProAct's customer service staff can answer questions in many languages. Visit www.FairfaxRxDiscountCard.com to print a card, get more information, or find participating pharmacies.

For members of the media who need more information, contact the Fairfax County Office of Public Affairs at 703-324-3187, TTY 711.

Long Term effects of Readiation Therapy

2011-11-06T17:47:00.000-08:00

BOSTON -- A majority of prostate cancer survivors reported long-term treatment-related adverse effects with surgery or radiation therapy, data from a Michigan survey showed.

About 70% of 2,500 survey respondents reported ongoing problems with adverse events, some of whom were more than 15 years removed from primary treatment.

The most commonly reported symptoms involved sexual and urinary function, but a substantial proportion of the men also had problems related to bowel function and vitality, as reported here at the American Association for Cancer Research's Frontiers in Cancer Prevention Research meeting.

"Without question, sexual symptoms were the most common and the most troubling to the men," said May Darwish-Yassine, PhD, of the Michigan Public Health Institute in Okemos. "It's a very significant issue, and primary care providers are not very attentive to it, nor are they free or perhaps comfortable to manage the problem."

Most prostate cancer patients contend with a variety of physical and psychosocial issues following primary treatment. Survivorship studies have generally followed patients for two to five years. However, early diagnosis and modern treatment have transformed clinical outcomes for prostate cancer, such that many men can expect to have a long lifespan following treatment.

"In Michigan, as with the rest of the country, nearly 100% of men diagnosed at the local stage live at least five years after diagnosis, and more than 90% of men live at least 10 years," said Yassine.

In an effort to determine the current state of the postdiagnosis experience, investigators initiated the Michigan Prostate Cancer Survivors Study to describe and quantify long-term symptoms men report following prostate cancer treatment. The study comprises data collected from approximately 2,500 men who had prostate cancer diagnoses from 1985 to 2004 and remained alive as of the end of 2005.

Men ages 75 and older accounted for 53% of study participants, followed by those 65 to 74 (33.3%), and 64 or younger (13.8%). Three-fourths of the participants were white, and 19% were black.

Investigators found that 11.1% of the men were less than five years removed from diagnosis, 40.9% were five to nine years postdiagnosis, 28.8% were 10 to 14 years, and 19.3% were 15 years or more from diagnosis.

Yassine reported that 67.5% of the men had had radical prostatectomy, including 55.1% who had had surgery as the only treatment.

A third of the men had had external beam radiation, 20% received hormonal therapy, and 10% received some form of internal radiation therapy.

About 70% of the men received only one form of therapy.

Study participants were asked to describe any symptoms they had within the four weeks prior to the survey. Among those who reported posttreatment symptoms, the most common fell into four categories: urinary, bowel, sexual, and vitality. For each category, the proportion of men who reported symptoms was:

Sexual, 89.6%

Urinary, 69.9%

Bowel, 44.8%

Vitality, 45%

The proportion of men reporting just one symptom in a category ranged from 7.5% for sexual function to 30.6% for urinary function.

Sexual problems were far and away the most common, with a majority of the men (50.3%) reporting four problems related to sexual function, and an additional 24.1% reporting three symptoms in that area.

Those symptoms included poor or no erection (reported by 55% to 85%), erection not reliable (reported by 54% to 87%), and erection not firm (reported by 61% to 89%.

The proportion of men reporting no sexual symptoms ranged from 4% of men 75 and older to 30.6% of men younger than 65.

Analysis of specific symptoms by type of therapy and age showed that after prostatectomy a majority of men (52% to 60%) with urinary symptoms reported urine leakage, regardless of age, and 37% to 50% reported frequency problems.

Among those with bowel problems, urgency was the most commonly reported symptom (25% to 37%).

With respect to vitality, 26% to 33% of men reported a lack of energy. A majority of men across all age groups reported no vitality problems.

Substantially fewer men who received only external beam radiation therapy responded to questions about specific symptoms. Even so, sexual symptoms predominated, as 56% to 90% of men in each age group reported problems with the frequency, reliability, and quality of erections. Among urinary symptoms, frequency was reported by a majority of men in all age groups. Few men reported bowel or vitality symptoms.

For each of the four principal symptom categories, the men were asked to rate the severity of their problems, ranging from "no problem" to "big problem." About 46% of men rated sexual symptoms as moderate or big problems, followed by vitality (24%), urinary (20%), and bowel (14%).

Darwish-Yassine and coinvestigators had no financial disclosures.

Posting ADT Piece: New Info on Intermittent therapy

2011-10-17T14:10:00.000-07:00

We have known since the mid-1990’s that androgen suppressive therapy could be used in an interrupted fashion, but we didn’t know until now that men were not sacrificing length of life in the hopes of having a better quality of life,” says Juanita M. Crook, MD, principal investigator and radiation oncologist with the British Columbia Cancer Agency. “The results of this trial will change the standard of care.”
The Canadian study, supported by a team of cross-border North American scientists, administered intermittent androgen deprivation in patients for eight months then stopped and restarted only when their PSA levels reached >3 ng/ml when off the treatment, compared to men treated with continuous androgen deprivation (CAD). The data showed that intermittent antiandrogen treatment was equivalent to continuous antiandrogen treatment with similar overall survival and quality-of-life measures. Biostatiscally, intermittent therapy was called “a non-inferior” (in laymen’s terms, “comparable”) arm of the trial—disease specific death was 18% in the intermittent arm compared with 15% in the continuous arm.
Dr. Crook believes the IAD method will be widely accepted. “There is no detriment to survival, some men see quality-of-life benefit, and it also happens to be cheaper,” says Crook.
Summary
Intermittent androgen deprivation provides similar outcomes to continuous therapy with the potential for fewer side effects and less disruption to quality of life—good news for many men and their families. IAD patients complained of fewer hot flashes and 35% of them had full recovery of serum testosterone after completing IAD. Cardiac events and osteoporotic fracture events were equal in both arms. Further, intermittent androgen deprivation offers cost-savings to health systems as both patients and the systems pay only 27% of the cost of continuous treatment.

No Prostate Cancer Screening,, Says USPSTF,

2011-10-06T13:41:00.000-07:00

(CNN) -- The U.S. Preventive Services Task Force, the group that told women in their 40s that they don't need mammograms, will soon recommend that men not get screened for prostate cancer, according to a source privy to the task force deliberations.

The task force is set to recommend a "D" rating for prostate specific antigen, or PSA, testing. Such a rating means "there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits," according to the group's website. The task force is set to propose this recommendation Tuesday, and then allow for a comment period before issuing a final recommendation.

According to a draft copy of a report scheduled to be released Monday, a review of studies shows screening with the PSA blood test results in "small or no reduction" in prostate cancer deaths.

The report adds that PSA testing is "associated with harms related to subsequent evaluation and treatments."

The PSA test can help determine if a man has prostate cancer. It is sometimes accompanied by a digital rectal exam

Tools Predicting Erectile Function after Treatment

2011-10-05T11:51:00.000-07:00

Context Sexual function is the health-related quality of life (HRQOL) domain most commonly impaired after prostate cancer treatment; however, validated tools to enable personalized prediction of erectile dysfunction after prostate cancer treatment are lacking.

Objective To predict long-term erectile function following prostate cancer treatment based on individual patient and treatment characteristics.

Design Pretreatment patient characteristics, sexual HRQOL, and treatment details measured in a longitudinal academic multicenter cohort (Prostate Cancer Outcomes and Satisfaction With Treatment Quality Assessment; enrolled from 2003 through 2006), were used to develop models predicting erectile function 2 years after treatment. A community-based cohort (community-based Cancer of the Prostate Strategic Urologic Research Endeavor [CaPSURE]; enrolled 1995 through 2007) externally validated model performance. Patients in US academic and community-based practices whose HRQOL was measured pretreatment (N = 1201) underwent follow-up after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer. Sexual outcomes among men completing 2 years' follow-up (n = 1027) were used to develop models predicting erectile function that were externally validated among 1913 patients in a community-based cohort.

Main Outcome Measures Patient-reported functional erections suitable for intercourse 2 years following prostate cancer treatment.

Results Two years after prostate cancer treatment, 368 (37% [95% CI, 34%-40%]) of all patients and 335 (48% [95% CI, 45%-52%]) of those with functional erections prior to treatment reported functional erections; 531 (53% [95% CI, 50%-56%]) of patients without penile prostheses reported use of medications or other devices for erectile dysfunction. Pretreatment sexual HRQOL score, age, serum prostate-specific antigen level, race/ethnicity, body mass index, and intended treatment details were associated with functional erections 2 years after treatment. Multivariable logistic regression models predicting erectile function estimated 2-year function probabilities from as low as 10% or less to as high as 70% or greater depending on the individual's pretreatment patient characteristics and treatment details. The models performed well in predicting erections in external validation among CaPSURE cohort patients (areas under the receiver operating characteristic curve, 0.77 [95% CI, 0.74-0.80] for prostatectomy; 0.87 [95% CI, 0.80-0.94] for external radiotherapy; and 0.90 [95% CI, 0.85-0.95] for brachytherapy).

Conclusion Stratification by pretreatment patient characteristics and treatment details enables prediction of erectile function 2 years after prostatectomy, external radiotherapy, or brachytherapy for prostate cancer.

K

ADT Does Not Increase Risk of Cariovascular Death

2011-10-05T11:42:00.000-07:00

October 5, 2011 (Miami Beach, Florida) — Androgen-deprivation therapy (ADT) is an effective treatment for men with "unfavorable-risk" prostate cancer, and it does not increase the risk for cardiovascular (CV) death, concludes a new study. These results contradict earlier suggestions that this risk might be increased.

The new findings come from a meta-analysis, the first on ADT and CV-related mortality, presented here at the American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting.

This "should be reassuring for the vast majority of men who have received ADT or are considering it," said lead author Paul Nguyen, MD, from Dana-Farber/Brigham and Women's Cancer Center in Boston, Massachusetts.

The study has an important caveat: the findings could differ in men with congestive heart failure or who have had a myocardial infarction.

Still, even with the study's limitations, these data offer a counterpoint to retrospective studies that found a higher risk for CV mortality among men receiving ADT for prostate cancer, explained Dr. Nguyen.

Those studies, plus data indicating an association between ADT and an increased risk for CV complications, led to a consensus statement last year from the American Heart Association, the American Cancer Society and the American Urological Society.

The statement, which was endorsed by ASTRO, asserted that "there may be a relation between ADT and cardiovascular events and death."

Subsequently, in October 2010, the US Food and Drug Administration called for new labeling on gonadotropin-releasing hormone (GnRH) agonists. The black-box warning now states that the agents "increase risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke)."

Improve Analysis of the Problem

In an interview with Medscape Medical News, Dr. Nguyen described the consensus statement as "everybody lining up against androgen-deprivation therapy."

He and a group of colleagues sought to improve the power of the statistical analysis of the problem.

They performed a literature review of randomized trials in prostate cancer that compared GnRH-agonist-based ADT with no ADT and that reported CV-related deaths. They found 8 studies that met their inclusion criteria, comprising a total of 4141 patients, all of whom had intermediate-risk prostate cancer or higher (but no metastatic or hormone-refractory disease). In 5 of the studies, the local therapy patients received was radiation; in the other 3 studies, patients underwent surgery or received no local therapy.

The risk for CV death was similar in the ADT and no-ADT groups (11.0% vs 11.2%). The relative risk for CV death for ADT, compared with no ADT, was 0.93 (95% confidence interval, 0.79 to 1.10; P = .41).

The results were similar in all the subgroups the investigators examined, said Dr. Nguyen, including the subgroups of short-course ADT (6 months or less), long-course ADT (3 years or more), men older than 70 years, and radiation use.

The meta-analysis provides additional reassuring news: ADT improves outcomes. Specifically, compared with no ADT, ADT reduced prostate-cancer-specific mortality (relative risk [RR], 0.68; P < .001) and all-cause mortality (RR, 0.88; P = .005).

Men With Preexisting CV Disease

This is a "great paper" that "employs modern epidemiologic methodology to seek out differences that would not have been seen in smaller studies," Phillip Devlin, MD, secretary/treasurer of ASTRO, told Medscape Medical News. Dr. Devlin is also from Dana-Farber/Brigham and Women's Cancer Center, and acknowledged that he is not a completely impartial commentator, as he is Dr. Nguyen's boss.

Dr. Devlin believes that patients will be calmed by these results, which provide a "sense of greater comfort" and allow clinicians to say that "there may be less risk than we thought" with ADT and cardiac death.

Nevertheless, clinicians should provide careful monitoring of patients on ADT for CV disease, said Dr. Devlin.

The study did not examine whether ADT is associated with a reduction in CV events such as congestive heart failure and myocardial infarction.

Retrospective data suggest that ADT harms men with preexisting CV disease, said Dr. Nguyen.

The extent of the harm is unclear, he reported. For instance, a 2009 study indicated that only 5% of men with a history of congestive heart failure and myocardial infarction were harmed by ADT, as reported by Medscape Medical News.

Dr. Nguyen is also the author of a study that found that men with high-risk prostate cancer have an increased risk for death with ADT if they have a history of congestive heart failure and myocardial infarction (RR, 2.6; P = .01).

Dr. Nguyen reports receiving research funding from Varian. Dr. Devlin has disclosed no relevant financial relationships.

American Society for Radiation Oncology (ASTRO) 53rd Annual Meeting: Abstract 11. Presented October 3, 2011.

[CLOSE WINDOW]
Authors and Disclosures
Journalist
Nick Mulcahy
Nick Mulcahy is a senior journalist for Medscape Hematology-Oncology. Before joining Medscape, Nick was a freelance medical news writer for 15 years, working for companies such as the International Medical News Group, MedPage Today, HealthDay, McMahon Publishing, and Advanstar. He is also the former managing editor of breastcancer.org. He can be contacted at nmulcahy@medscape.net.

Excess Mortality for Older Patients with Prostate Cancer

2011-10-05T11:29:00.000-07:00

population-based analysis of mortality data for men diagnosed with prostate cancer from three European nations suggests that “a small but important group of older patients” initially present with late stage prostate cancer and die rapidly as a consequence.

The study by Holmberg et al., published in Cancer Epidemiology, was designed to compare patterns of survival among men with prostate cancer from England, Norway, and Sweden between 2001 and 2004, taking account of the ages of the patients and the length of follow-up.

The study included data from 179,112 men in England, 23,192 in Norway and 59,697 in Sweden. All study data were based on information available from the national cancer registries for the three countries involved. Estimates of the “excess mortality” among men with prostate cancer were calculated using a period approach for relative survival.

The results of the study showed that:

The overall, age-standardized 5-year survival was
76.4 percent for English patients
80.3 percent for Norwegian patients
83.0 percent for Swedish patients
English patients had
The lowest overall survival
The lowest overall survival among men aged ≥ 80 years in particular
The majority of the excess deaths in England were confined to the first year of follow-up.
In their conclusion, the authors suggest that the early demise of the “small but important group of older patients” may be because (a) they first present with late stage disease and (b) they have severe concomitant comorbidities in addition to their prostate cancer. It is clear that this problem is more common in England than in Norway or Sweden, which may reflect male health-related behavior patterns in the UK by comparison with Scandinavian countries.

New Bayer PCa Drug(QLGETA)

2011-10-04T15:27:00.000-07:00

An experimental drug developed by Bayer AG (BAYN) and Algeta ASA (ALGETA) prolonged the lives of men with prostate cancer that’s spread to their bones, a study found.

A trial of the drug, called Alpharadin, in 922 men was stopped early after an interim analysis showed that patients receiving it on top of standard treatment had a 30 percent lower risk of dying than those receiving just the current therapy, according to data presented today at a cancer conference in Stockholm.

The results suggest Alpharadin may be the first drug to improve survival in men with cancer of the prostate that’s spread to the bone, a worsening of the disease that occurs in 90 percent of men with the advanced stage. Bayer plans to apply for regulatory approval in Europe and the U.S. by the middle of next year, said Anna Koch, a spokeswoman for the Leverkusen, Germany- based company.

“This is really practice-changing,” Jean-Charles Soria, a professor of medicine at the Institute Gustave Roussy in Paris, said at a briefing with reporters. “Pending approval, it’s going to be a major player in prostate cancer.”

Alpharadin, also known as radium-223 chloride, may generate peak sales of 640 million euros ($864 million) by 2018, according to Alistair Campbell, an analyst at Berenberg Bank in London. The drug works by emitting small doses of alpha radiation that damage the DNA of cancer cells, killing them, without harming healthy cells.

To contact the reporter on this story: Simeon Bennett in Geneva at sbennett9@bloomberg.net

New Chip to Test Compounds for Toxcicity Early on

2011-09-20T13:24:00.000-07:00

http://news.sciencemag.org/scienceinsider/2011/09/white-house-boosts-transla
tional.html?ref=hp

The NIH and the Defense Advanced Research Projects Agency will each invest
as much as $70 million over five years on a chip to test compounds for
toxicity before they are administered to humans. The agencies will also
coordinate with the FDA, which could utilize the chip to accelerate the
drug-approval process. "If things are going to fail, you want them to fail
early," said NIH Director Francis Collins. "Now you'll be able to find out
much quicker if something isn't going to work." Meanwhile, the NIH is
searching for someone to lead its proposed National Center for Advancing
Translational Sciences.

Prostate Cancer Info Link Interesting Article

2011-09-20T13:00:00.000-07:00

If you are among the people in America who agree with one or other of the following two statements, you need an immediate crash course in what approval of a new drug by the U.S. Food & Drug Administration (FDA) does actually mean:

FDA only approves drugs without serious side effects.
FDA only approves “extremely effective” drugs.
According to a recent survey conducted by Schwartz and Woloshin and just published in the Archives of Internal Medicine:

25 percent of 2,944 people surveyed did indeed believe that the FDA only approves drugs without any serious side effects.
39 percent of 2,944 people surveyed did indeed believe that the FDA only approves “extremely effective” drugs.
In fact, neither of these two things are true at all. So what is the truth?

In reality, FDA approval only implies that — after careful review — the agency has determined that “the benefits [of the approved agent] are judged to be greater than the harms. It doesn’t mean that they’re big and important,” said Woloshin in a statement to Reuters, which has also reported on this study.

Schwartz and Woloshin also assessed people’s perceptions about the relative value of newer and older medicines based on FDA approval. The two drugs used in this test actually had approximately equal efficacy and approximately the same side effects in the management of heartburn, but some 66 percent of those questioned picked the newer medication when asked to make a choice between the two.

In fact, in many cases, FDA approval is not based on direct comparisons of effectiveness and safety between drug X and drug Y, so there may be no good reasons to believe that one is any better or safer than the other. In the case of new cancer drugs, the FDA does try hard to encourage drug developers to carry out trials that compare a new drug to the “standard of care” at the time a new trial is being designed, but it is not always possible to do this, and events may overtake reality.

As an example, it would be nice to know whether MDV3100 is or is not safer or more effective than abiraterone acetate in the treatment of castration-resistant prostate cancer (CRPC). However, abiraterone acetate wasn’t approved at the time the Phase III trials of MDV3100 were being designed. At that time, the standard of care for any man with CRPC — metastatic or otherwise — was still chemotherapy with docetaxel + predisone. Unless either the survival benefit demonstrated by MDV3100 is a lot more or a lot less than 3.9 months compared to placebo, or the side effects of MDV3100 are a lot worse or a lot better than those exhibited by patients on abiraterone acetate compared to placebo, there will be no way to assess whether one drug is any “better” than the other. For very similar reasons, we have no idea of the relative merits of treating men with CRPC with either abiraterone acetate of sipuleucel-T.

The FDA does its best to ensure that important new drugs for conditions like prostate cancer are moved through the regulatory process in a timely manner. In recent years, they have become pretty successful at this. However, we are likely, over time, to discover than some of these new drugs have additional, and potentially significant, side effects that were simply not seen or reported in the relatively small numbers of patients who participate in the clinical trials that customarily lead to drug approval.

Here is a brief list of some very simple things that it is well worth understanding about what an FDA approval of a new drug actually does and does not mean:

FDA approval means that, on average, the benefits of using a drug outweigh the risks in a well-defined set of patients with a specific disorder.
FDA approval means that the FDA has worked closely with the drug developer to create detailed prescribing information for the new drug
The prescribing information for every drug includes
Information about what types of patients the drug is approved for
Information about the effectiveness of the drug in this set of patients
Information about the side effects of the drug when used in this set of patients
Warnings about serious adverse effects (up to and including death) associated with the use of the drug
Information about the recommended dose of the drug and how it should be given to or taken by patients
FDA approval of a drug never implies that
A drug is completely safe
A drug has no side effects
All the side effects of a drug have been discovered
A drug will necessarily be effective for you as an individual
On average, the benefits of using a drug will outweigh the risks if the drug is used to treat an unapproved condition
A drug is “better” than other drugs for the approved condition (unless it has been compared to another drug or drug in a “head-to-head” clinical

Family Physician Prostate Cancer Screening

2011-09-06T17:40:00.000-07:00

Prostate Cancer: Who Should Be Treated?

Am Fam Physician. 2011 Aug 15;84(4):424.

See related article on prostate cancer treatments.

What are the pros and cons of treating prostate cancer?

Prostate cancer is usually found in the early stages, when treatment can cure it. Some men have more aggressive cancer that spreads quickly; treatment can be life-saving in these cases. However, treatment can also cause urinary, sexual, and bowel problems.

Why is treatment not recommended for some people?

In most men, prostate cancer grows so slowly that it will not lead to death within 10 years, even if the cancer is not treated. Prostate cancer is usually found late in life, so men who are expected to live less than 10 years and who have a slow-growing cancer will probably not benefit from treatment.

How do I know how aggressive my prostate cancer is?

Your doctor will do a biopsy and a blood test to find out your risk. These tests will also tell you whether the cancer has spread outside the prostate. Treatment is recommended if the risk of the cancer spreading is high, or if it has already spread.

What treatment options are there?

The two most common options are surgery and radiation therapy. Your doctor can help you choose which treatment is best for you. After either treatment, about two out of three patients have problems getting an erection. However, many of these patients usually had this problem before the cancer was found. Surgery is more likely to cause urinary problems, and radiation therapy is more likely to cause bowel problems. One type of radiation therapy, called brachytherapy (BRAY-kee-THER-uh-pee), has fewer side effects. In brachytherapy, radioactive seeds are put inside the prostate gland.

What happens if I choose not to treat my prostate cancer?

If you choose not to treat your cancer, your doctor will have you follow a program called active surveillance. In this program, you will have blood tests and biopsies done on a regular basis. If these tests find that your risk has increased, your doctor may recommend that you consider treatment.

This handout is provided to you by your family doctor and the American Academy of Family Physicians. Other health-related information is available from the AAFP online at http://familydoctor.org.

This information provides a general overview and may not apply to everyone. Talk to your family doctor to find out if this information applies to you and to get more information on this subject.

Copyright © 2011 by the American Academy of Family Physicians.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.

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PCa Guidance to Family Doctors

2011-09-06T17:31:00.000-07:00

The August 15 issue of American Family Physician — supposedly one of the most widely read medical journals in America — carried an article by Mohan and Schellhammer entitled “Treatment options for localized prostate cancer.” Unfortunately the full text of this article is not available on line for the average reader.

In their article, Mohan (a family physician) and Schellhammer (a urologic oncologist who is himself a prostate cancer patient with progressive disease) offer family doctors rather more than a standard review of the diagnosis and treatment of prostate cancer, and it is the first review of prostate cancer to appear in American Family Physician since 2005. To that extent, it should be seen as a key overview on the subject of prostate cancer for the primary care community.

The article makes a number of evidence-based key points about the treatment of localized prostate cancer for the family practitioner, as follows:

Treatment of localized prostate cancer is unlikely to improve the survival of [most] men with low- and very low-risk disease and all such active interventions have potentially negative effects on health-related quality 0f life.
Despite this information, some 70 to 90 percent of men with localized prostate cancer choose an interventional treatment shortly after a positive biopsy.
More than 50 percent of such patients significantly over-estimate the survival benefit of treatment.
Treatment of localized prostate cancer should normally be recommended for higher-risk patients.
Risk level can be estimated based on cancer stage and grade, PSA level, and comorbidity-adjusted life expectancy (CALE).
Patients can be counseled that surgery and external beam radiation therapy are almost equal in efficacy for the treatment of localized prostate cancer.
Brachytherapy is an appropriate form of monotherapy in low-risk, localized prostate cancer.
Active surveillance is a reasonable management option for low- and very low-risk, localized prostate cancer.
The article also includes a series of tools that may be useful to primary care physicians and their patients in assessing risk and the appropriateness of differing forms of treatment, including:

A questionnaire to assess patient understanding of the benefits and risks of different treatment options.
A simplified algorithm (derived from the prostate cancer guidelines of the National Comprehensive Cancer Center Network) that can be used to aid selection of appropriate management of localized prostate cancer
A table to assist in assessment of a patient’s Charlson comorbidity index (CCI)
A table to assist in assessment of a patient’s comorbidity-adjusted life expectancy (CALE)
A table summarizing expected adverse effects at 2 years after treatment for localized prostate cancer
The Klotz (Canadian) protocol for active surveillance of men with localized prostate cancer (including indications for interventional treatment)
The article is supplemented by a handout for family physicians to use with their patients entitled “Prostate Cancer: Who Should Be Treated?” The full text of this brief handout is available on line.

Support group leaders and other prostate cancer educators are encouraged to ask the assistance of their family physicians or their local medical librarian in obtaining a copy of this article for their personal use.

It is inevitable that an article like this will not meet the approval of everyone in the prostate cancer community. It is an easy article to “pick holes in” if one is of a mind to do so. However, even with such limitations, what this article does do is to provide a series of tools and sound general information that will help the family practitioner to become more involved in the provision of appropriate guidance to patients diagnosed with prostate cancer — and particularly those patients of 60 to 80 years of age who comprise a significant majority of those being diagnosed with localized, low-risk prostate cancer today.

AlphaPhosphatase S, One Patient's Experience

2011-08-30T09:48:00.000-07:00

Alkaline Phosphatase
An alkaline phosphatase (ALP) test measures the amount of the enzyme ALP in the blood. ALP is made mostly in the liver and in bone with some made in the intestines and kidneys . It also is made by the placenta of a pregnant woman.

The liver makes more ALP than the other organs or the bones. Some conditions cause large amounts of ALP in the blood. These conditions include rapid bone growth (during puberty), bone disease (osteomalacia or Paget's disease), or a disease that affects how much calcium is in the blood (hyperparathyroidism), vitamin D deficiency, or damaged liver cells.

If the ALP level is high, more tests may be done to find the cause.

Why It Is Done
A test for alkaline phosphatase (ALP) is done to:

Check for liver disease or damage to the liver. Symptoms of liver disease can include jaundice, belly pain, nausea, and vomiting. An ALP test may also be used to check the liver when medicines that can damage the liver are taken.
Check bone problems (sometimes found on X-rays), such as rickets, osteomalacia, bone tumors, Paget's disease, or too much of the hormone that controls bone growth (parathyroid hormone). The ALP level can be used to check how well treatment for Paget's disease or a vitamin D deficiency is working.
How To Prepare
An alkaline phosphatase test is often done at the same time as a routine blood test. You do not need to do anything before having a routine blood test.

If you are having a follow-up ALP test, you may be asked to not eat or drink for 10 hours before the test. The ALP level generally goes up after eating, especially after eating fatty foods.

Many medicines may change the results of this test. Be sure to tell your doctor about all the nonprescription and prescription medicines you take.

Talk to your doctor about any concerns you have regarding the need for the test, its risks, how it will be done, or what the results will mean. To help you understand the importance of this test, fill out the medical test information form(What is a PDF document?).

How It Is Done
The health professional drawing your blood will:

Wrap an elastic band around your upper arm to stop the flow of blood. This makes the veins below the band larger so it is easier to put a needle into the vein.
Clean the needle site with alcohol.
Put the needle into the vein. More than one needle stick may be needed.
Attach a tube to the needle to fill it with blood.
Remove the band from your arm when enough blood is collected.
Put a gauze pad or cotton ball over the needle site as the needle is removed.
Put pressure to the site and then a bandage.

One Patient's Experience with AlphaPhosphatase S

First, the prostate specific antigen (PSA) is a substance expressed by a healthy prostate gland. It is easily measured in the blood steam. While arguments rage about its use to diagnose the presence of prostate cancer in the beginning, there is little argument about its reliability to follow the post-treatment progress of men like me. Usually, a climbing PSA means an increase in the tumor population. Next, alkaline phosphatase (ALP). “ALP S” can be measured in the blood stream as part of a routine liver function test known as CMP (complete metabolic panel). Bone-specific ALP is measured from a separate blood specimen. It is believed to reliably track tumor progression in the skeleton during treatment, even when other indicators may be less reliable.

Comparing the values of these indicators from February 9, just after we started chemotherapy with Taxotere, with those from August 11, 75 days after starting Zytiga, we see disappointing increases in both ALPs and rocket-sled behavior from the PSA. What might this mean? Answer: we really don’t know.

There are several possibilities, but the bottom line at this point is: the September test must show some “benefit” from the Zytiga or I go back on chemotherapy - this time with a similar drug called Jevtana - and hope we can bring the three indicators back to the pre-Zytiga levels of early June

2011-07-31T12:46:00.000-07:00

We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.

As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.

Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.

Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.

SCOTT T. WILLIAMS
Washington, July 12, 2011

The writer is vice president of the Men’s Health Network.

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Prostate Cancer Risks for Men inBreastCancerFamilies

2011-07-26T12:10:00.000-07:00

THE "NEW" PROSTATE CANCER INFOLINKEntries RSS | Comments RSS Follow The "New" Prostate Cancer InfoLink news blog on TWITTER or FACEBOOK.

Copyright © 2008-11 Prostate Cancer International, Inc.Prostate cancer and prostate cancer-specific survival of men from breast cancer-prone families
Posted on July 26, 2011 by Sitemaster
i1 Votes

An Australian research team has used data from 148 men from 1,423 families identified through the Kathleen Cunningham Consortium for Research into Familial Breast Cancer (kConFab) to assess the risks associated with prostate cancer in males from breast cancer-prone families, and most particularly from those families in which the BRCA2 gene mutation is prevalent.

Although it is well understood that there is a strong association between the presence of the BRCA2 gene mutation and the risk for development of prostate cancer, the consequent clinical presentation of prostate caner in such men, and their treatment-related outcomes, have not previously been thoroughly characterized.

kConFab is a multi-center research consortium that identifies and studies families at high risk for breast cancer from across Australia and New Zealand. Thorne et al. were able to search the kConFab database to identify 148 male patients who met the following three criteria:

They had all been diagnosed with prostate cancer.
They were all confirmed as either a carrier or a non-carrier of a family-specific BRCA pathogenic mutation.
Comprehensive clinical and treatment data were available on all 148 men.
Detailed analysis of the clinical and familial data from these 148 male prostate cancer patients established the following:

The men all had high risk of disease progression, irrespective of mutation status.
Carriers of the BRCA2 mutation had an increased risk of overall and prostate cancer-specific mortality (hazard ratio [HR] = 4.5; P = 8.9 × 10^-5) by comparison with non-carriers.
For both carriers and non-carriers of the BRCA2 mutation given first-line treatment with curative intent, long-term survival outcomes were relatively poor (when compared to the survival outcomes of men from non-breast cancer-prone families
Serum PSA readings taken prior to diagnosis in 90 percent of these men, after age adjustment, were above clinical significance.
Based on the D’Amico risk stratification criteria
77.5 percent of the carriers of the BRCA2 mutation had high-risk disease
58.7 percent of non-carriers also had high-risk disease.
BRCA2 mutation status was an independent prognostic indicator of overall survival.
Thorne et al. conclude that:

If diagnosed with prostate cancer, all men in breast cancer-prone families are at significant risk of developing an aggressive form of the disease.
This information should be made clear by genetic counselors and medical professionals in discussions about cancer risk with men in such families, whether the individual is a carrier or a non-carrier of a BRCA gene mutation.
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Support for Provenge, a Prostate Cancer Dug

2011-07-18T08:20:00.000-07:00

Provenge, a Prostate Cancer Dug

CloseLinkedinDiggMySpacePermalinkTo the Editor:

We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.

As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.

Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.

Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.

SCOTT T. WILLIAMS
Washington, July 12, 2011

The writer is vice president of the Men’s Health Network.

American Cancer Society on PSA Screening

2011-07-13T17:34:00.000-07:00

The American Cancer Society (ACS) recommends that men have a chance to make an informed decision with their health care provider about whether to be screened for prostate cancer. The decision should be made after getting information about the uncertainties, risks, and potential benefits of prostate cancer screening. Men should not be screened unless they have received this information.

The discussion about screening should take place at age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.

This discussion should take place starting at age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65).

This discussion should take place at age 40 for men at even higher risk (those with several first-degree relatives who had prostate cancer at an early age).

After this discussion, those men who want to be screened should be tested with the prostate specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as a part of screening.

If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the patient’s general health preferences and values.

Men who choose to be tested who have a PSA of less than 2.5 ng/ml, may only need to be retested every 2 years.

Screening should be done yearly for men whose PSA level is 2.5 ng/ml or higher.

Because prostate cancer grows slowly, those men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.

Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in the patient's health, values, and preferences.

Mediterranean Diet Fundamentals

2011-07-09T15:23:00.001-07:00

The Mediterranean diet has been shown to reduce the risk of death from both heart disease and cancer, lower the risk of developing type 2 diabetes, control weight, lower blood pressure and cholesterol levels, and even reduce the risk of Alzheimer’s disease. Convinced?

Here are the 11 foundations of the Mediterranean diet to help you get started:

Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet

A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.

Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)

University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)

In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under

Mediterranean Diet Fundamentals

2011-07-09T15:23:00.000-07:00

Malecare's Prostate Cancer Under (age) 50 program

2011-07-09T11:06:00.000-07:00

Malecare's Prostate Cancer Under (age) 50 program began in late 2004 and Malecare's Advanced Prostate Cancer program began in late 2006. Today, we are asking you to tell us how we can make them better. Please email your suggestions and comments. We are asking in this free form way, as we know that each of you approaches your diagnosis, treatment and lives uniquely ... we want to fit your needs into our programs rather than create programs that you have to make an effort to fit into.
So, if you were diagnosed with prostate cancer before the age of 50, tell us what help is missing or what can be improved in your lives...in the services and support groups we offer....anything, everything....the sky and your imagination are your only limits. Family and friends are welcome to email their comments, too.
Same goes for those of you initially diagnosed with late stage prostate cancer, or were diagnosed with a recurrence of prostate cancer after a primary treatment.
I can tell you that we are revising the Advanced Prostate Cancer handbook that approx. 6,000 of you received. We're writing Version 2.0 and would welcome your critique of Version 1.x We're also planning many more teleconferences for you to attend.
All of our Malecare volunteer's have lots of work to do this summer, and we hope that you will help by taking just a few minutes to email your comments to me, Darryl, at darryl@malecare.org

P.S. Our advocacy efforts continue, with work focused on protecting the federal Prostate Cancer Research Program, building awareness with the second annual Men's Health Night on November 20 and trying to increase collaboration with our brother and sister cancer survivor nonprofits...more news about that, next month

More Information on Provenge's FDA Approval

2011-07-06T20:35:00.000-07:00

From: Dendreon Corporation Investor Relations
[mailto:newsdesk@broadcast.shareholder.com]
Sent: Thursday, June 30, 2011 4:52 PM
To: Riccio, Scott
Subject: Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE

Dendreon Corporation

Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE

- FDA Approves Los Angeles Immunotherapy Manufacturing Facility, CMS
Announces National Coverage Decision, and Product Specific Q-Code Effective
-

SEATTLE, June 30, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN)
today announced significant milestones that support broad availability for
on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular
immunotherapy for the treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC).
* The U.S. Food and Drug Administration (FDA) approved the Los Angeles
immunotherapy manufacturing facility on June 29, 2011. The facility includes
36 workstations, and Dendreon will bring these on in a staged approach.
* In addition, the Centers for Medicare and Medicaid Services (CMS)
issued a final National Coverage Decision (NCD) for PROVENGE on June 30,
2011, requiring Medicare contractors to cover the use of PROVENGE for
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer. The NCD will standardize
coverage processes across the country for all Medicare patients with
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer and provides the local Medicare Administrative
Contractors (MACs) specific criteria, consistent with the label, on how
PROVENGE should be covered.
* PROVENGE was issued a product specific Q-code effective July 1,
2011, which allows for electronic submission of claims and is expected to
accelerate time to payment for physicians.
* As part of this expanded access, Dendreon supports programs to
provide comprehensive assistance for eligible patients seeking access to
treatment with PROVENGE, including through grants to independent foundations
and establishment of a patient assistance program for uninsured patients.
Dendreon provides grants to independently run foundations providing
qualifying patients with financial assistance for co-pays, co-insurance, and
treatment-related travel costs.

"These significant achievements support broad access to PROVENGE, the
foundation of care for men with asymptomatic or minimally symptomatic
metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D.,
president and chief executive officer of Dendreon. "The increased capacity
and positive National Coverage Decision by CMS in conjunction with the
patient assistance programs will ensure patients who may benefit from
treatment with PROVENGE have increased access to it."

For information about these programs, please visit www.provenge.com
or call 1-877-336-3736.

PROVENGE Indication and Safety

PROVENGE was approved by the U.S. Food and Drug Administration in April 2010
as the first autologous cellular immunotherapy for the treatment of
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested
for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients
in four randomized clinical trials who underwent at least one leukapheresis
procedure. The most common adverse events (incidence greater than or equal
to 15%) reported in patients in the PROVENGE group are chills, fatigue,
fever, back pain, nausea, joint ache, and headache. Serious adverse events
reported in patients in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In
controlled clinical trials, severe (Grade 3) acute infusion reactions were
reported in 3.5% of patients in the PROVENGE group. Reactions included
chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness,
headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5
acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's
ongoing commitment to patients, Dendreon will conduct a registry of
approximately 1,500 patients to further evaluate a small potential safety
signal of cerebrovascular events. In four randomized clinical trials of
PROVENGE in prostate cancer patients, cerebrovascular events were observed
in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in
the control group.

For more information on PROVENGE, please see the full Prescribing
Information at www.provenge.com or call
1-877-336-3736.

Medicare now covers first FDA-approved immunotherapy for PCa treatment

2011-07-06T20:30:00.000-07:00

Medicare now covers first FDA-approved immunotherapy for prostate cancer treatment

Medicare patients with metastatic prostate cancer can get a first-of-its kind treatment just approved by the Food and Drug Administration, under a final coverage decision issued today by the Centers for Medicare & Medicaid Services (CMS).

Autologous cellular immunotherapy, known clinically as sipuleucel-T, is marketed in the United States as Provenge, for treating some forms of prostate cancer in seriously ill patients. Today’s decision is effective immediately.

Provenge activates a patient’s own immune system to defend him against prostate cancer. The treatment consists of a multi-day regimen in which the patient’s white blood cells are collected and exposed to proteins that direct the white blood cells to fight prostate cancer cells. After the patient’s cells are treated, the patient receives his own cells back into his body in order to stimulate his immune system to fight the prostate cancer. This regimen is repeated over several weeks for a total of three treatments.

“We are optimistic that innovative str ategies may improve the experience of care for our beneficiaries who have cancer,” said CMS Administrator Donald M. Berwick, M.D. “CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes.”

Prostate cancer is the most common non-skin cancer in men in the United States. The cancer forms in the prostate, a gland in the male reproductive system, which can spread to other parts of the body and threaten life. In 2009, an estimated 192,280 new cases of prostate cancer were diagnosed and an estimated 27,360 men died. According to the National Cancer Institute, prostate cancer is most commmonly a cancer of older men, with most men diagnosed after 65 and the median age at diagnosis of 72.

CMS internally initiated the national coverage determination process for Provenge for multiple reasons, including: variations in local coverage; questions about the appropriate benefit category for Provenge; and inquiries from Congress. There was no prior NCD on this technology, and local contractors were generally making case by case determinations.

CMS convened the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a group of nationally recognized independent medical and scientific experts, on November 17, 2010 to make recommendations about the evidence. The MEDCAC votes supported coverage of Provenge for the FDA labeled indication and did not support coverage for unlabeled uses.

Today’s coverage decision includes coverage of Provenge for the uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

More information for patients and health professionals about FDA’s approved uses of Prpvemge is online at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210037.htm.

“CMS is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label,” said Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards & Quality. “Similar to other tr eatment decisions, individual patients should discuss the risks and benefits with their physician to make an individual decision.”

The final coverage decision is available on the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Autologous%20Cellular% 20Immunotherapy%20Treatment%20of%20Metastatic%20Prostate%20Cancer&bc=ACAAAAAAIAAA&NCAId=247&.

Free New Cancer Support Services

2011-06-21T19:39:00.000-07:00

WASHINGTON, D.C., June 14, 2011 - The Cancer Support Community (CSC) -- an
international non-profit dedicated to providing support, education and hope
to people impacted by cancer -- today announced a free new service:
CancerSupportSource(tm), an innovative mobile application providing cancer
patients and their caregivers with a unique set of tools addressing their
physical, social and emotional concerns related to living with cancer and
its treatment. The app is available for download
le.com/us/app/cancersupportsource/id402342273?mt=8&ls=1> via the iTunes
Store (category: Medical).

Whole Genome Sequencing for Prostate Cancer

2011-06-21T14:49:00.000-07:00

Whole Genome Sequencing for Prostate Cancer
Today’s announcement regarding the sequencing of whole prostate cancer genomes is an historic development in the fight against prostate cancer. The ability to sequence whole genomes will spare some patients from unnecessary treatments and side effects while eliminating an estimated $1.5 billion that is spent each year on overtreatment. The complete research findings will be published in the February 10 issue of Nature. The following Q and A is from content discussed during a teleconference announcing the significance of the findings and of whole genome sequencing to prostate cancer research.

Why is this discovery historic for prostate cancer research, and all cancer research generally?

A great journey begins with a small step. This is PCF’s first “Lewis and Clark” moment exploring the genomic landscape of prostate cancer. For the first time, researchers have uncovered a comprehensive genetic map of seven patients’ prostate tumors. Each of the seven maps offers a macroscopic view of the complete genetic sequence and mutations that might underlie and cause each patient’s disease. The whole genome view also shows us how prostate cancer is complex in a way that is different from other cancers. Instead of having many “spelling errors” or point mutations, prostate cancer has an unprecedented number of large rearrangement segments called “DNA fusions.”

What should patients be asking urologists today that they couldn’t ask yesterday?

Although these findings have not yet been translated into widely employed clinical practices, patients can begin to ask their respective medical teams about participating in studies that use whole genome sequencing in clinical trials. Opportunities for employing genomic scans in research and treatment studies for prostate cancer patients are rapidly expanding.

How much does it cost to sequence a whole prostate cancer genome? How long does it take?

The current estimated cost of sequencing a whole genome is $20,000 or less. Experts predict that the cost of routine sequencing will ultimately be around $5,000 per genome. (This figure compares favorably to the cost of $90,000-$150,000 per patient for a radical prostatectomy followed by several years of androgen deprivation therapy using Lupron.) The process of whole genome sequencing for a single patient currently takes between 2 and 3 weeks.

How will whole genomic sequencing accelerate the development of new medicines and diagnostics for prostate cancer patients?

Knowledge of DNA fusions from leukemia genome sequencing led to breakthrough medicines for chemotherapy-resistant leukemia. PCF believes that prostate cancer genome sequencing could follow suit and lead to a cancer-specific tests or fusion-specific medicines for distinct types of prostate cancer. Additionally, information provided by sequencing a given tumor could facilitate matching up a patient to existing clinical trials targeting DNA fusions and mutations—PCF is currently monitoring 11 trials of this kind.

What does the genome look like to a doctor or a patient?

The DNA code of each of the multiple tumors sequenced contains 3 billion letters. Depicting the sequence of these letters in a linear fashion would make it hard to visualize the important patterns and features of the structural variation with the code. It would also be exceedingly long to read.

Instead of sifting through a 3-billion letter code, a diagram was developed as a short-hand tool for visualizing important relationships within the genome. It was created with Circos software and is called the Circos plot. Designed with the express purpose of aiding in the visualization of genomic data, its circular layout is analogous to a clock face. Just as a clock face displays time through the use of a fixed dial indicating the hours in a 12-hour cycle, the Circos plot displays the 23 chromosome pairs on which the entire human genome is stored.

These chromosomes are numbered clockwise on the outer circumference of a circle plot. The demarcations within the circle relate information about what might be important for a doctor or patient to know about the genome being studied. On the chart below, the green ticks represent losses of coding information and the purple arcs represent gene fusions, how genetic material goes from the “right place” to the “wrong place” in the genome.

Scientists can quickly assess a Circos plot just as patients can easily glance at a clock face and tell time. Essentially, the Circos plot is an individualized, unique portrait of each patient’s prostate cancer, akin to a CT Scan of the entire genome.

What kinds of cancers were sequenced? Does this data help us distinguish between aggressive and non-aggressive prostate cancer?

All seven patients had cancers that were Gleason Grade 7, 8, or 9 (aggressive prostate cancers). These patients’ cancers were hand-picked to represent meaningful, advanced cancers (i.e. cancers that, without surgery or treatment, could possibly progress and take the life of the patient). An important question to ask is what do lower grade tumors in patients undergoing proactive surveillance look like by whole genome sequencing on a Circos plot. It may well be that indolent tumors have a much “quieter” genome, missing far less code and showing far less damage—a Circos plot without many lines or ticks. If we broadened this study by sequencing thousands of patients and following them in the clinic, we might be better able to distinguish indolent cancers with the tendency to remain “quiet” from those that require aggressive treatment.

Were these genomes just a snapshot in time for these patients? If you were to sample the same patients again would they have changed already?

Yes. In this study, the sequencing captures a snapshot of the seven patients’ tumors at the time of surgery. Conceivably you could take multiple “snapshots” of the genome at the time of diagnosis, prognosis, treatment, and throughout survivorship.

Now that we have these genomic portraits, what do you expect scientists around the world to do with the information? How will the data be made publically available?

This data will be carefully studied to compare and contrast the prostate cancer genome with other cancer genomes (i.e. breast cancer genomes) where we might find clues for understanding how to design better drugs for both kinds of cancers. Additionally, learning more about how certain genes are mutated or fused gives us insight into the fundamental processes of why cancer is caused, how and why it does or does not spread, and why it does or does not go into remission with certain existing treatments. With regard to the seven tumors sequenced, the patients’ identities have all been protected; however, any scientist around the world who logs into a database and fills out the appropriate consent form can responsibly access the information. Every person who uses the data must identify him or herself.

Do the whole genome maps help us explain the disproportionate burden of prostate cancer incidence and death in African-Americans and other affected populations?

Not yet, but large-scale populations studies are now urgently needed to address this important question. For studies on this scale, it takes several thousand patient samples to compare and contrast the patterns that may exist in the Circos plots in order to assess whether the genome can tell us more about the undue burden.

Listen to the Entire Teleconference

Teleconference Participants:

Dr. Jonathan W. Simons (moderator)
President & CEO, PCF
Dr. Levi Garraway (Co-lead investigator)
Dana-Farber Cancer Institute, The Broad Institute

Dr. Michael Berger
Memorial Sloan-Kettering Cancer Center
Dr. Mark Rubin (Co-lead investigator)
Weill Cornell Medical College

Dr. Ash Tewari
Weill Cornell Medical College
Dan Zenka
VP of Communications & Patient Advocate, PCF

The FDA Warning on Drugs Treating Enlarged Prostate

2011-06-21T14:31:00.000-07:00

By Steven Reinberg
HealthDay Reporter

Thursday, June 9 (HealthDay News) --The FDA issued a warning concerning drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.

In a statement released Thursday, the agency said the drugs involved include popular medications sold under the brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).

According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.

The agency is advising doctors not to start patients on these drugs until prostate cancer -- which can mimic the symptoms of an enlarged prostate -- and other urological conditions have been ruled out.

According to the agency, this new warning is based on the results of two large prostate cancer trials.

Although these trials did not include Propecia, which is prescribed to treat hair loss in men, its label is also being updated. However, the FDA said "the applicability of the Avodart and Proscar studies to Propecia, is currently unknown."

All of these drugs are part of a class of medications called 5-alpha reductase inhibitors (5-ARI). According to the FDA, Proscar, Avodart and Jalyn are approved to treat symptoms of enlarged prostate, while Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is a lower-dose version of Proscar.

Merck issued a statement Thursday on the FDA ruling.

"Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997," the company statement said. "Merck's goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions."

Less than a year ago, GlaxoSmithKline asked the FDA to approve the use of Avodart to prevent prostate cancer, although the FDA declined that request in January. The company based its reasoning on the results of one of the trials on which the agency is now basing its new warning.

In addition to this new side effect, recent research has shown that Proscar, Propecia and Avodart are all associated with increasing the risk of erectile dysfunction in men who take the medications.

Commenting on the FDA warning, prostate cancer expert Dr. Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston, said, "I think that the warning is appropriate. The risk is very small, but not zero."

"What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs -- even though you are less likely to get a low-grade cancer."

Why that is is not clear, D'Amico said. "But I think the warning is fair," he added.

The drugs really do work in preventing prostate cancer, D'Amico said. "You have to weigh the 24 percent reduction against the 1 percent increased incidence of high-grade disease," he said.

"These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention," D'Amico said.

Copyright © 2011 HealthDay. All rights reserved.

Defense Department 2012 Prostate Research Prog

2011-06-17T13:39:00.000-07:00

THE "NEW" PROSTATE CANCER INFOLINKEntries RSS | Comments RSS Follow The "New" Prostate Cancer InfoLink news blog on TWITTER or FACEBOOK.

The "New" Prostate Cancer InfoLink has been developed to become a primary source of accurate, current, and topical information about prostate cancer for patients and their families.
This web site is a service of Prostate Cancer International.

Other PCI web sites
El Cáncer de Próstata Latinoamérica
Prostate Cancer Africa

Prostate Cancer Caribbean

Solidarité Prostate InfoLink

The "New" Prostate Cancer InfoLink is intended for informational purposes only. It is not engaged in rendering medical advice or professional services.
News and information provided on this site should not be used for diagnosing or treating any health problem or disease.

The "New" Prostate Cancer InfoLink is not a substitute for professional care. If you have or suspect you may have a health problem, please consult your healthcare provider.

Perspective Confidentiality Disclosure Reliability Courtesy

Copyright © 2008-11 Prostate Cancer International, Inc.Funding for the DoD PCRP in FY 2012
Posted on June 16, 2011 by Sitemaster
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So here’s a quick status report on the potential funding for the US Department of Defense (DoD) Prostate Cancer Research Program (PCRP) for the fiscal year (FY) that begins on October 1, 2012 and runs through September 30, 2013.

As regular readers of this news blog may remember, funding for FY 2011 was renewed at the same level of $80 million as we had seen in the preceding few fiscal years. Congress has now initiated the process of looking at funding for the Department of Defense in FY 2012, and our current understanding is that there will be cuts to many of the Congressionally Directed Medical Research Program (CDMRP) initiatives, including the PCRP.

At this time, the House Appropriations Committee has proposed a 20 percent cut to the PCRP, which will mean a reduction in the total budget for PCRP from $80 million to $64 million for FY 2012. This is not good, but it could have been a lot worse. However, this is also just the first step in what may be a long process. We believe that the House of Representatives will vote on this bill some time next week. Hopefully, it will pass without any further fuss, but then we will have to wait and see what the Senate decides to do, and that could take a while.

For new readers, the PCRP is the largest single source of US government funding specifically dedicated to prostate cancer research. At its height, in FY 2001, a total of $100 million was dedicated to this initiative. Securing continuing funding for the PCRP is a critical priority for the Prostate Cancer Roundtable here in the USA. As a group, under the current economic circumstances, it is probably safe to say that the Roundtable members would be willing to live with a 20 percent budget cut of this type — even if we don’t like it! However, …

Two-Tiered Prostate Cancer Surveillance

2011-06-14T18:33:00.000-07:00

null
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OncologyStat®One Source, Many Resources.® By Elsevier
News
Two-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
Two-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
J Smith
20110418
2011 May 18
Elsevier Global Medical News
Find more items about these cancer types:

ProstateTwo-Tiered Prostate Cancer Surveillance Could Curb Overtreatment
Elsevier Global Medical News. 2011 May 18, J Smith

A two-tiered system of surveillance could reduce prostate cancer deaths by half while also curbing overdiagnosis and overtreatment, according to results from a large Swedish study.

The system would allow men who test for high levels of prostate-specific antigen (more than 1.6 ng/mL) in their 40s to undergo close surveillance as they age, while the rest - approximately half of all men - would need to be tested only three times between the ages of 44 and 60 years.

The findings, released May 18 and highlighted during a press briefing at which the American Society of Clinical Oncology offered a preview of studies to be presented at its annual meeting in June, could help lead to a more "rational" screening strategy, according to the study's investigators.

While there is evidence that PSA screening can detect prostate cancer at an early, curable stage, it is viewed as problematic because of the risk of overtreatment. PSA levels are not necessarily indicative of present cancer, and a large number of men must be screened to prevent a single death.

The investigators, led by Dr. Hans Lilja of Memorial Sloan-Kettering Cancer Center in New York, conducted a case-control study nested within a cohort of 12,090 Swedish men who provided blood between 1974 and 1986. A total of 4,999 provided repeat samples 6 years later. The investigators also looked at an independent cohort of 1,167 men who provided blood at age 60 years. Men with evidence of prostate cancer metastasis or death (n = 252) were matched 3:1 with controls.

The study found that 44% of prostate cancer deaths occurred in men who had the top 10% of PSA levels (greater than 1.6 ng/mL) for their age group when they were tested for the first time between the ages of 44 and 50 years.

Men whose PSA levels remained below the median for the population in their age group saw a progressively declining rate of death or metastasis.

The investigators found that 28% of metastases or deaths from prostate cancer over the next 27 years occurred in men aged 44-50 years whose initial screens showed a PSA below the median in the population (0.7 ng/mL).

For men aged 51-55 years with a PSA lower than the median (0.8 ng/mL), the risk of metastatic prostate cancer or death was 18% over 27 years. At age 60 years, only 0.5% of deaths or metastases occurred in men with a PSA less than the median for that age (1.1 ng/mL).

The findings show that PSA levels at the time of initial screening among men aged 44-50 years can accurately predict the risk of death from prostate cancer or metastatic prostate cancer up to 30 years later. Concentrating surveillance in this group of men could allow the rest to undergo only three lifetime tests at the ages of 44, 51-55, and 60 years, the investigators concluded.

Dr. Lilja disclosed owning stock in Arctic Partners, a firm that holds patents for PSA assays.

Copyright © 2010 International Medical News Group

Abiraterone ProlongsOverall Survival

2011-06-14T18:25:00.000-07:00

Abiraterone Prolongs Survival in Metastatic Castration-Resistant Prostate Cancer
Elsevier Global Medical News. 2011 May 25, MA Moon

Abiraterone acetate, a selective inhibitor of androgen biosynthesis, prolonged overall survival, reduced mortality risk by 35%, and delayed time to disease progression in men with metastatic castration-resistant prostate cancer who had already undergone chemotherapy, according to a report in the May 26 issue of the New England Journal of Medicine.

"The use of hormonal agents is typically not considered in patients who have received chemotherapy. These results show that continued androgen-receptor signaling contributes to disease progression, and they provide support for the evaluation of other endocrine therapies in this [advanced] stage of the disease," wrote Dr. Johann S. de Bono of the Institute of Cancer Research and Royal Marsden Hospital, Sutton (England), and his associates.

Several previous studies have demonstrated that, despite medical or surgical castration, prostate cancers continue to have sufficient levels of androgens, perhaps from synthesis within the tumor itself, to propel tumor growth. In phase I and phase II trials, abiraterone acetate - which potently blocks cytochrome P450 c17 (CYP17), an enzyme critical to testosterone synthesis - has shown promising antitumor activity even in advanced prostate cancer.

Dr. de Bono and his colleagues performed this international phase III randomized double-blind trial at 147 sites to compare daily oral therapy with four 250-mg abiraterone acetate tablets plus low-dose prednisone against placebo plus low-dose prednisone. They enrolled 1,195 men who had previously received docetaxel and showed disease progression despite ongoing androgen deprivation.

The primary end point of the study was overall survival.

At a preplanned interim analysis, active treatment was found to reduce the risk of death by 35%, compared with placebo. Mortality was 42% with active treatment, compared with 55% with placebo. Median overall survival was 14.8 months with abiraterone, compared with 10.9 months with placebo, the investigators reported (N. Engl J. Med. 2011;364:1995-2005).

This survival benefit "was consistent across all subgroups, and ... robust after adjustment for stratification factors in a multivariate analysis," they said.

Based on these findings, the trial was unblinded and patients in the placebo group were allowed to switch to active treatment.

"All the secondary end points analyzed provided support for the superiority of abiraterone acetate over placebo," Dr. de Bono and his associates said. Treatment response was greater with abiraterone whether measured by PSA levels (29% response vs. 6%) or Response Evaluation Criteria in Solid Tumors (RECIST) criteria (14% vs. 3%). Time to PSA progression was longer (10.2 months vs. 6.6 months), as was median progression-free survival on radiography (5.6 vs. 3.6 months).

Active treatment reduced the risk of disease progression by 42% when assessed by PSA levels and by 33% when assessed by radiographic imaging.

Exploratory end points, including pain palliation and time to 25% of patients having a skeletal event, also consistently favored abiraterone over placebo.

"This study validates the hypothesis that the biosyntehsis of steroid hormones downstream of CYP17 contributes to progression of castration-resistant prostate cancer in a subgroup of men for whom this disease remains driven by steroid ligands and should not be described as 'hormone refractory.' Since these men cannot be identified a priori, continuing to call this disease 'androgen independent' or 'hormone refractory' is imprecise," Dr. de Bono and his associates said.

"As our study shows, blocking androgen synthesis by inhibiting CYP17 can produce tumor responses in patients who no longer have a response to standard hormonal therapies and who had received docetaxel-based chemotherapy," they added.

Compliance with abiraterone acetate therapy was high, "and side effects were easily manageable and reversible, despite the advanced age and level of frailty of the study population," the investigators said.

Toxic effects included hypokalemia, hypertension, and fluid retention, "which were largely abrogated by the use of low-dose prednisone," they wrote.

The rates of drug discontinuation and dose reduction were low, and therapy "did not appear to increase the risk of metabolic changes or symptoms associated with chronic androgen deprivation. Nevertheless, longer follow-up is warranted to evaluate late toxic effects," they noted.

In editorial accompanying the study, Dr. Emmanuel S. Antonarakis and Dr. Mario A. Eisenberger wrote that the findings "provide a proof of principle that metastatic castration-resistant prostate cancer remains androgen-driven" (N. Engl. J. Med. 2011;364:2055-8).

The results of this phase III trial led to Food and Drug Administration approval of abiraterone [Zytiga] in late April for patients who had received docetaxel, but they also "provide sufficient evidence of efficacy to justify the use of abiraterone in all patients with metastatic castration-resistant prostate cancer (i.e., even those with no previous chemotherapy treatment)," said Dr. Antonarakis and Dr. Eisenberger, who are with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore.

Moreover, "it is clear ... that our knowledge of the biologic mechanisms involved in the progression of metastatic castration-resistant prostate cancer has reached a level at which the discovery of more effective targeted approaches will probably further improve outcomes," they added.

Johns Hopkins receives funding from Cougar Biotechnology and participated in this clinical trial, but Dr. Antonarakis and Dr. Eisenberger were not involved. They reported ties to Sanofi-Aventis, Millennium, Astellas, and Tokai.

This study was sponsored by Ortho Biotech Oncology Research and Development, a unit of Cougar Biotechnology, with further support provided by the Medical Research Council of the United Kingdom, the Experimental Cancer Medical Centre, the National Institute for Health Research Biomedical Research Centre, and the Prostate Cancer Foundation. Dr. de Bono is employed by the Institute of Cancer Research, where abiraterone was designed and synthesized, and which has a commercial interest in the drug. He and his associates reported ties to numerous drug and biotechnology companies.

Finasteride & Dutasteride Raise Risk Of Hi-Gr PCa

2011-06-12T14:36:00.000-07:00

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Finasteride And Dutasteride Raise Risk Of High-Grade Prostate Cancer, FDA Informs
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Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology; Regulatory Affairs / Drug Approvals
Article Date: 10 Jun 2011 - 7:00 PDT

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Although finasteride and dutasteride lower overall risk of developing prostate cancer, they raise the chances of developing high-grade prostate cancer, a more serious form of the disease, the FDA (Food and Drug Administration) has announced. The Agency adds that the risk is low; but doctors need to be aware of this.

The FDA announced that all 5-alpha reductase inhibitor (5-ARI) medications will now have new safety information about the risk of developing high-grade prostate in their labeling, in the Warnings and Precautions section.

Examples of 5-ARI class medications include finasteride (Proscar, Propecia), dutasteride (Avodart), turosteride, bexlosteride and izonsteride. They are drugs with antiandrogenic activity and are used to treat benign prostatic hyperplasia (prostate gland enlargement) and androgenic alopecia (hair loss, baldness).

The FDA evaluated two randomized controlled trials - PCPT (the Prostate Cancer Prevention Trial), which compared finasteride 5mg against placebo for 7 years, and REDUCE (Reduction by Dutasteride of Prostate Cancer Events trial), which compared dutasteride 0.5 mg against placebo for 4 years. Both trials were measuring prostate cancer risk reduction in males aged 50+ years.

Even though both studies demonstrated an overall reduction in prostate cancer risk with both drugs, they also showed a higher risk of high-grade prostate cancer.

High-grade prostate cancer (Gleason score between 8 and 10) is the most deadly form of prostate cancer. It is an aggressive cancer which grows and spreads into surrounding areas rapidly. The cancer cells are large, very difficult to treat, and frequently reappear.

The FDA stresses that patients should talk to their doctors first before deciding on whether to change or stop any prescription medication.

Finasteride is marketed by Merck. Dutasteride is marketed by GlaxoSmithKline.

Written by Christian Nordqvist

View drug information on dutasteride; Propecia; Proscar.

Copyright: Medical News Today

Androgen Ablation &Bone Metastasis

2011-06-10T14:13:00.000-07:00

Androgen Ablation
Androgen deprivation therapy (ADT) is commonly used in the treatment of prostate cancer.53 Survival in men with nonmetastatic prostate cancer treated with ADT is long, with a median survival of greater than 7 years.54 Hence, long-term effects on bones are of particular concern. At least one study has also suggested skeletal fractures as an adverse predictor of overall survival in men with prostate cancer.55

Even at baseline, men with prostate cancer who have not received ADT have a higher incidence of osteoporosis than the general age-matched population.56 Effects of hormone treatment most likely compound the problem.21

A Danish case-control registry study compared more than 15,000 men aged older than 50 years who had fractures with 45,000 men who did not. The authors found that a diagnosis of prostate cancer was associated with an increased odds ratio (OR) for fracture of 1.8 (95% CI, 1.6-2.1) and ADT was associated with an increased OR of 1.7 (95% CI, 1.2-2.5). It was noted that the increased risk became apparent soon after diagnosis and persisted even in long-term survivors.57

Retrospective cohort studies of men who have survived prostate cancer for many years have demonstrated that ADT therapy is associated with an increase in fracture risk (Table 2).58-65 Shahinian et al performed a Surveillance, Epidemiology, and End Results (SEER) database study of 50,613 men who were diagnosed with prostate cancer between 1992 and 1997. Five years after starting treatment, 19.4% of survivors who received ADT developed a fracture at any site, whereas only 12.6% of survivors not receiving ADT developed a fracture.58 Dickman et al studied almost 18,000 men who were treated for prostate cancer with bilateral orchiectomy, and compared their fracture risk with that of approximately 360,000 healthy controls. The authors found that those who had undergone orchiectomy had a fracture risk over 10 years of 12% at the femoral neck alone, compared with 5% in the general population.60 Smith et al conducted a claims-based retrospective cohort study of 3887 men with nonmetastatic prostate cancer receiving GnRH agonists compared with 7774 who did not receive these agents. GnRH agonists were associated with an increased clinical fracture risk (7.88 clinical fractures per 100 person-years in the GnRH group vs 6.51 per 100 person-years in controls; relative risk [RR], 1.21; 95% CI, 1.14-1.29 [P < .001]).59 However, these studies are limited in that fractures were not designated as osteoporotic versus pathologic, and no relation with BMD was performed.

2011-05-31T13:11:00.000-07:00

NCCN Annual Report
Support NCCN About NCCN
More Oncology Drug Shortages
By Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor

Recent news is plentiful with stories about how local hospitals and physician practices are struggling to provide their patients with drugs they critically need in today’s climate of drug shortages. In a previous eBulletin article, we described some ways to cope with the ever-expanding list of drugs that are in short supply. According to the FDA Drug Shortages website, three additional drugs (daunorubicin, thiotepa, and vincristine) have been added to the list of injectable drugs that are in short supply and used for the active treatment of cancer since that article was written. The shortage resolved for one drug previously on the list, which is carmustine. The list of oncology drugs currently experiencing a shortage stands as follows:

Bleomycin
Cisplatin
Cytarabine
Daunorubicin
Doxorubicin
Etoposide
Leucovorin/levoleucovorin
Mechlorethamine
Thiotepa
Vincristine.
As you can see, many of the drugs on this list are critical pieces of well-established chemotherapy regimens. In the short term, the US Food and Drug Administration (FDA) has some ability to help resolve some shortages. However, this ability is somewhat limited, especially if the cause of the shortage is due to circumstances beyond their control. Nonetheless, the FDA may be able to expedite the review of submissions by manufactures for a new product or manufacturing change that, if approved, may help to increase the supply of the drug that is currently experiencing a shortage. Additionally, the FDA works with manufacturers to identify sources of raw material or encourage others to increase production of the drug. Lastly, the FDA can utilize enforcement discretion to temporarily allow the importation of a drug from other countries, although the FDA has maintained that this practice is rare.1 Interestingly, it appears that the FDA is considering allowing the importation of certain oncology products (e.g., cytarabine, thiotepa).2, 3

Recently, legislation that may offer some long-term relief to this crisis was introduced to Congress. The “Preserving Access to Life Saving Medications Act (S. 296)” proposes to establish an early warning system so that manufacturers must report to the US Food and Drug Administration (FDA) on conditions that would likely result in a drug shortage. It also would provide the FDA with the power to impose financial penalties for manufacturers who fail to comply with this reporting.

As more drugs are added to the list of those in short supply, there is growing concern among the public regarding how patients are affected by these shortages. Hopefully, the actions of the FDA and Congress will relieve some of these problems and we will again see an adequate supply of these important medications.

Dick: have you seen this available in the US>????? A Pill that gives men with advanced prostrate cancer an extra 4 months of life has come a

2011-05-01T16:02:00.000-07:00

A Pill that gives men with advanced prostrate cancer an extra 4 months of life has come a step closer to being approved for use in Britain. Zytiga is a hormonal drug that cuts of the source of testosterone, which makes prostrate cancer cells grow.
Standard hormone treatments for prostrate cancer blocks production of male hormone in the testes, but recent research shows that tumours can produce their own supply, as does the adrenal gland. Zytiga block all testosterone generation. It can be used in up to 80 per cent of patients with aggressive drug resistant prostrate cancer who have run out of options after exhausting a range of anti-hormonal therapies and chemotherapy. The drug is not available for use on the NHS, but makers Johnson and Johnson have applied for licensing approval in Europe that could be granted by the end of this year. That approval looks more likely after U.S. watchdogs at the Food and Drug Administration gave the green light to the drug there nearly 2 months earlier than expected, following its successful trial. A trial on almost 800 patients in 13 countries found those taking the drug combined with conventional steroid treatment survive ed for about 15 months compared with 11 months on steroid alone.
The study was cut short so all patients could be given Zytiga clinical name abiraterone acetate - after independent monitors determined a clear survival benefit.
Around 250,000 men in the UK are living with prostrate cancer, with 37,000 new cases diagnosed each year. It is the biggest cancer killer after lung cancer, with 10,000 men dying from the disease each year. Zytiga was discovered by British scientists at the institute of Cancer Research.
Professor Johann de Bono, of the ICR said "This news will be incredibly important ot prostrate cancer patients and their families"

Rd Wine &Reveratrol. Good for Your Health

2011-03-09T14:20:00.000-08:00

While the news about red wine might sound great if you enjoy a glass of red wine with your evening meal, doctors are wary of encouraging anyone to start drinking alcohol. That's because too much alcohol can have many harmful effects on your body.

Still, many doctors agree that something in red wine appears to help your heart. It's possible that antioxidants, such as flavonoids or a substance called resveratrol, have heart-healthy benefits.

How is red wine heart healthy?
Red wine seems to have even more heart-healthy benefits than other types of alcohol, but it's possible that red wine isn't any better than beer, white wine or liquor for heart health. There's still no clear evidence that red wine is better than other forms of alcohol when it comes to possible heart-healthy benefits.

Antioxidants in red wine called polyphenols may help protect the lining of blood vessels in your heart. A polyphenol called resveratrol is one substance in red wine that's gotten attention.

Resveratrol in red wine
Resveratrol might be a key ingredient in red wine that helps prevent damage to blood vessels, reduces "bad" cholesterol and prevents blood clots.

Most research on resveratrol has been done on animals, not people. Research in mice given resveratrol suggests that the antioxidant might also help protect them from obesity and diabetes, both of which are strong risk factors for heart disease. However, those findings were reported only in mice, not in people. In addition, to get the same dose of resveratrol used in the mice studies, a person would have to drink over 60 liters of red wine every day.

Some research shows that resveratrol could be linked to a reduced risk of inflammation and blood clotting, both of which can lead to heart disease. More research is needed before it's known whether resveratrol was the cause for the reduced risk.

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r Risk-based system to reduce unnecessary biopsies

2011-03-03T14:30:00.000-08:00

OncologySTAT: How will we select men for biopsy in the future, and where are
we in terms of identifying molecular markers for aggressive prostate tumors?

Dr. Parker: I have no doubt that in the future we will be using risk
calculators based on multiple risk factors in order to decide who gets a
biopsy and who doesn't. Now, the adoption of these risk calculators has been
slow, partly because there are so many different risk calculators and no
consensus on which is better than any other, and partly because they have
not been extensively validated in separate cohorts. There is a pressing need
to validate these risk calculators and to see which of the currently
available risk calculators does the best job in different settings. I think
it is important that individual centers that do large numbers of prostate
biopsies should be auditing their results, seeking to validate these risk
calculators with a view to using them in future practice. So, in the very
near future, investigators should not be relying on PSA thresholds but
rather on the risk calculator that works best in their setting. There are a
large number of new markers that are coming through, which appear to predict
the risk of finding prostate cancer and, more importantly, the risk of
finding high-grade prostate cancer on biopsy. There is no doubt that some of
them will provide extra utility over and above the standard risk calculators
that are available today.

But, I'm also confident that none of these new markers is going to tell the
whole story. We should not expect any new marker to replace PSA and be used
on its own, to indicate who should get a biopsy and who shouldn't. Rather,
these new markers will need to be incorporated into existing risk
calculators. Among the novel markers, one of the best known is the urinary
PCA3 score, which looks promising. There are also a plethora of germline
genetic markers, which also appear to put men at increased risk of prostate
cancer, although, as yet, I'm not aware of any germline marker that is
associated with high-grade prostate cancer.

The fact that there are so many markers being evaluated underlines the need
for us to move from PSA-based decision-making to risk-based decision-making.
Right now, we have traditional risk factors, which I mentioned earlier, but
in 5 years' time, we are going to have a large number of new risk factors,
whether they are urinary markers, or blood markers, or germline genetic
markers. The only way we are going to make sense of all these new markers is
to use them as part of a risk-based approach.

So, again, the decision whether or not to have a prostate biopsy should be
made, in the future, not on a man's PSA level, but rather on the risk of
finding high-grade prostate cancer.

OncologySTAT: Then, aside from validating these different scoring systems
and validating more of the marker research, what are key, yet-unanswered
questions that need to be tested in clinical trials?

Dr. Parker: It will be important to know how effective these risk
calculators will be in avoiding unnecessary biopsies and reducing
over-diagnosis. Roobol et al have made a very nice first attempt at
estimating what the impact would be. They selected 10,000 men who took part
in the European randomized trial of prostate cancer screening, and described
what happened in the trial, given that biopsy was indicated for men with a
PSA level greater than 3 ng/mL. Then, they compared that with what would
have happened if they had used a risk threshold using the European risk
calculator.5

What they found was that about one-third of all the prostate biopsies would
have been avoided and that the number of indolent prostate cancers detected
would have been significantly reduced. Their work is a first step at showing
what could be gained from moving from a PSA-based system to a risk-based
system.

The other point to make is that while the immediate and obvious advantages
of using a risk-based system would be to reduce unnecessary biopsies and
reduce over-diagnosis, there is also a possible further benefit, because it
may be that we would be able to find harmful prostate cancers earlier,
before a man's PSA rises above the standard threshold, and finding it
earlier might improve the effectiveness of treatment. That is speculation,
but it is a further reason why we should be moving towards a risk

Xgeva(denosumab)is more effective than Zometa® (

2011-03-03T13:40:00.000-08:00

Xgeva Reduces Bone Complications From Prostate Cancer

Among men with bone metastases from prostate cancer, Xgeva™ (denosumab) was more effective than Zometa® (zoledronic acid) at delaying or preventing bone complications such as fracture. Results from this Phase III clinical trial were published in The Lancet.

Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including prostate cancer—have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression, and may require treatment with surgery or radiation therapy.

Bisphosphonate drugs such as Zometa have been commonly used to reduce the risk of complications from bone metastases. Xgeva is a newer type of drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Xgeva was approved by the U.S. Food and Drug Administration (FDA) in 2010 for the prevention of bone complications in patients with bone metastases from solid (not blood-related) cancers, including prostate cancer.

To directly compare Xgeva to Zometa among prostate cancer patients with bone metastases, researchers conducted a Phase III clinical trial. The study enrolled 1,901 patients with metastatic, hormone-refractory prostate cancer. Study participants were assigned to receive either Xgeva or Zometa. Xgeva is given as a subcutaneous (under-the-skin) injection; Zometa is given intravenously (IV).

The objective of the study was to determine whether the occurrence of bone complications (“skeletal related events”) differed between the two study groups. The bone complications that were evaluated were fracture, radiation to the bone, surgery to the bone, and spinal cord compression.

The results of this study suggest that Xgeva is more effective than Zometa at delaying or preventing skeletal complications in prostate cancer patients with bone metastases.

Reference: Fizazi K, Carducci M, Smith M et al. Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomized, double-blind study. The Lancet. Early online publication February 25, 2011.

PSA Velocity, Helpful by Itself?

2011-02-28T09:51:00.000-08:00

Current guidelines for the early detection of prostate cancer recommend a biopsy for men whose P.S.A. rises rapidly, no matter what the initial level. But a new study says that the practice does not help patients find aggressive cancers and that it results in many unnecessary biopsies.

P.S.A., or prostate-specific antigen, rises with age, and what is considered normal varies. In general, a level under 4 nanograms per milliliter is considered safe. But even with a normal reading, an increase of 0.35 nanograms per year is widely believed to be high enough to require a biopsy.

Researchers examined the records of 5,519 men with a base-line P.S.A. under 3. They followed them for seven years with yearly tests and a biopsy if the level rose above 4.

They also analyzed P.S.A. velocity — the rate of change in readings from year to year. But after adjusting for age, base-line P.S.A. and other factors, they found little evidence that giving a biopsy to men whose velocity was greater than 0.35 helped find prostate cancer. And it was particularly useless in uncovering the most aggressive types of cancer, the ones most important to treat.

The researchers, writing in the March 16 issue of The Journal of the National Cancer Institute, concluded that using P.S.A. velocity for prostate cancer detection is ineffective, that it leads to unnecessary biopsies and that references to it should be removed from professional guidelines and policy statements.

Andrew J. Vickers, the lead author, drew an analogy: A basketball player’s height, he said, is important to his ability to play, and it correlates very closely with his shoe size. But once you know his height, his shoe size is irrelevant to judging his value as a player.

Similarly, it is easy to demonstrate a statistical relationship between sharp rises in P.S.A. and cancer, but the correlation reveals no more information than is already available with a P.S.A. reading, a digital examination and a family history. It is irrelevant in deciding whether a biopsy is needed.

Not all experts agree. Dr. Anthony V. D’Amico, a professor of radiation oncology at Harvard, said that the methodology of Dr. Vickers’s study was sound, but that the data gathered were almost certainly flawed.

The problem, Dr. D’Amico said, is that many factors that have nothing to do with prostate cancer can cause a rapid increase in prostate-specific antigen. Sexual activity, riding on a bicycle or on horseback, a recent colonoscopy, a bladder or prostate infection, even variations in the ways laboratories perform the test can radically affect the readings.

“It may well be that the high velocity in your case is not important,” he said. “But before you reach that conclusion, I would get a repeat P.S.A.” If there is still a spike after eliminating those other possible causes, he continued, a biopsy should be the next step.

Dr. Vickers, a researcher at Memorial Sloan-Kettering Cancer Center in New York City, agreed that prostate cancer was only one of many reasons for a high P.S.A. “A doctor sees a high P.S.A. and says, ‘Could this be cancer or some other reason?’ ” he said. “Well, the thought was that P.S.A. velocity could help you think this through” — that measuring the rate of change would be decisive.

But in practice, Dr. Vickers said, it does not work. If he had strictly applied the guidelines to the men in his study, he said, one in every seven would have had to have a biopsy. This would mean millions of American men would need biopsies, he said, with almost none of them revealing a cancer.

Dr. Vickers and his colleagues acknowledged that there might be better methods of calculating P.S.A. velocity that could lead to more accurate predictions, and that some effect might have been found if the patients had been followed for more than seven years.

But at this point, he is firmly against biopsies on the basis of velocity alone. “If your P.S.A. is in the normal range, you shouldn’t get a biopsy,” he said. “Changes or spikes in P.S.A. are not something to worry about if your P.S.A. is still normal.”

sequencing the complete DNA of an individual organism's genome.

2011-02-09T15:04:00.000-08:00

Today’s announcement regarding the sequencing of whole prostate cancer genomes is an historic development in the fight against prostate cancer. The ability to sequence whole genomes will spare some patients from unnecessary treatments and side effects while eliminating an estimated $1.5 billion that is spent each year on overtreatment. The complete research findings will be published in the February 10 issue of Nature.

What is whole genome sequencing?
It is the process of sequencing the complete DNA of an individual organism's genome.

How much information is this?
If the DNA sequence of the human genome were compiled into books, it would fill 200 volumes of a Manahattan-sized phone book (or one 35-foot high phone book.) People won't be carrying this data around on flash drives either - it would still take a significant hard drive to store all of this information.

What did this research do?
Researchers mapped the complete genome of prostate cancer. They took the genetic material from the tumors of seven patients with advanced prostate cancer and then compared these cancer genomes to the normal genomes of these same patients. This information is visually presented using a Circos plot.

What is a Circos plot?
A Circos plot is a diagram created with Circos software for visualizing data in a circular layout. It was originally designed to aid in the visualization of genomic data.

Here are the Circos plots of the seven prostate cancer patients' genomes:

What does this mean for men diagnosed with prostate cancer?
The data expands our fundamental understanding of the disease’s biology and provides the technical and clinical roadmap for improving patient treatment and outcomes. Ultimately, every patient with prostate cancer will get a Circos plot with the whole genome sequencing of their biopsy as a unique portrait of the code that makes their prostate cancer manifest as it does.

How much does it cost to sequence a whole genome?
The current estimated cost of sequencing a whole genome is $25,000 or less. Experts predict that the cost of routine sequencing will ultimately be around $5,000 per genome. (This figure compares favorably to the cost of $90,000-$150,000 per patient for a radical prostatectomy followed by several years of androgen deprivation therapy using Lupron.)

Research Background
Work conducted by lead institutions, The Broad Institute, Dana-Farber Cancer Institute and Weill Cornell Medical College, along with 15 other collaborating institutions, completed this initial project ahead of a planned NIH effort.

Teleconference
The Prostate Cancer Foundation (PCF) hosted a teleconference to provide insight and commentary from leading professionals in the field. Click on the image above right to listen to the teleconference.

Listen to the Teleconference

Teleconference Participants:

Dr. Jonathan W. Simons (moderator)
President & CEO, PCF
Dr. Levi Garraway (Co-lead investigator)
Dana-Farber Cancer Institute, The Broad Institute

Dr. Michael Berger
Memorial Sloan-Kettering Cancer Center
Dr. Mark Rubin (Co-lead investigator)
Weil Cornell Medical College

Dr. Ash Tewari
Weill-Cornell Medical College
Dan Zenka
VP of Communications & Patient Advocate, PCF

© 2011 prostate cancer foundation
Media Center | Terms of Use | Privacy Policy | Site Map | Site Credit

Provenge Treatment Results to Date(Jan 2011)

2011-02-05T11:56:00.000-08:00

Sipuleucel-T is an autologous active cellular immunotherapy used in the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC). It is the first therapeutic cancer vaccine to receive US FDA approval. Approximately 3 days prior to each infusion of sipuleucel-T, patients undergo a leukapheresis procedure for collection of autologous peripheral blood mononuclear cells. Preparation of sipuleucel-T involves enrichment for antigen-presenting cells from the leukapheresis product and activation ex vivo with a recombinant fusion protein (PA2024). In the randomized, double-blind, placebo-controlled IMPACT study in patients with metastatic CRPC, sipuleucel-T was associated with a 22% relative reduction in the risk of death (hazard ratio 0.78; p = 0.03), which was the primary endpoint of the trial. After a median follow-up period of 34.1 months, median survival was 4.1 months longer with sipuleucel-T than placebo (25.8 vs 21.7 months). There was no significant between-group difference for the median time to objective disease progression (a secondary endpoint). Almost all patients treated with sipuleucel-T in clinical trials reported an adverse event, although these were mild or moderate in severity (grade 1 or 2) in most patients. The most common adverse events (e.g. infusion-related events, such as chills and fever) generally occurred within the first day after administration of sipuleucel-T and resolved within 2 days.

Written by:
Plosker GL. Are you the author?

Reference: Drugs. 2011 Jan 1;71(1):101-8.
doi: 10.2165/11206840-000000000-00000

PubMed Abstract
PMID: 21175243

RPP, the most cost-effective treatment for OCPCa.

2011-02-05T11:43:00.000-08:00

Written by Lynda Coghlan
Wednesday, 02 February 2011 07:52
Urology Centre, Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.

sashurol@gmail.com

With the increasing prevalence of prostate cancer and evolving methods for the definitive treatment of OCPCa, health economic analyses will be critically important, albeit difficult to carry out. Preliminary studies point to RPP as the most cost-effective treatment for OCPCa. The quickest postoperative recovery, in experienced hands, occurs in RARP and RPP, with ORPP having a slightly, but statistically in significant, shorter hospital stay. It should be stressed that initial treatment costs are not the only important factor in healthcare costs. Readmission for early and late complications and the loss of productivity resulting from variation in time to return to work, need also to be considered. Loss of productivity may also vary in cost between different institutions and countries depending upon the proportion of patients employed. Further large-scale multicentre studies are necessary to assess this.

Written by:
Kommu SS, Eden CG, Luscombe CJ, Golash A, Persad RA. Are you the author?

Reference: BJU Int. 2011 Jan;107(1):1-3.
doi: 10.1111/j.1464-410X.2010.09885.x

PubMed Abstract
PMID: 21176067

UroToday.com Prostate Cancer Section

Active Surveillance & Ffocal Therapy Treat PCa

2011-02-05T11:32:00.000-08:00

Written by Lynda Coghlan
Thursday, 03 February 2011 03:12
USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.

Active surveillance and focal therapy for prostate cancer have been proposed as treatment alternatives for prostate cancer. In this review, we track the emerging technologies that will support the viability of such management strategies.

Widespread prostate-specific antigen (PSA) testing and extended prostate biopsy practice patterns have resulted in a significant increase in the diagnosis of low-risk prostate cancer. As most low-risk prostate cancers may not require radical treatment, alternatives for appropriately selected patients have been proposed and implemented - namely, active surveillance and focal therapy. Both alternatives to radical therapy require accurate mapping and precise targeting of lesions within the prostate, for which current technological shortfalls limit their clinical utility. The emerging tools that will help overcome these challenges include refined imaging modalities, three-dimensional modeling for planning and tracking intervention, elastic fusion image technology, and automated mechanical delivery of the intervention needle.

Current prostate biopsy technologies have largely advanced as separate entities. Further refinement of these innovations continue, but the ultimate challenge will be integrating them into one comprehensive platform.

Written by:
Ukimura O, Hung AJ, Gill IS. Are you the author?
Reference: Curr Opin Urol. 2011 Mar;21(2):115-20.
PubMed Abstract
PMID: 21178631
UroToday.com Prostate Cancer Section

Last Updated ( Thursda

New VA Coverage for Agent orange

2011-01-09T18:17:00.000-08:00

Politico
© August 31, 2010
By David Rogers

Age and Agent Orange are closing in on Vietnam veterans, a legacy of hurt for those who served — and a very big bill for American taxpayers.

It’s a world turned upside-down from decades ago when returning soldiers had to fight to get attention for deadly lymphomas linked to the herbicide. Now the frailties of men in their 60s — prostate cancer, diabetes, heart disease — lead the list of qualified Agent Orange disabilities, and the result has been an explosion in claims — and the government’s liability.

The latest expansion, approved by Veterans Affairs Secretary Eric Shinseki in October, adds ischemic heart disease and Parkinson’s and will cost at least $42 billion over the next 10 years. The VA estimates 349,000 individuals are already receiving Agent Orange disability benefits and that number could soon reach 500,000 — or one out of every four surviving Vietnam veterans by the VA’s count.

As the costs rise, so do the questions about the science involved and the box Washington put itself in by failing to address Agent Orange’s impact more directly at the outset.

And because Vietnam service is still such a political minefield for American politicians, the most telling, often edgy debate is among veterans themselves.

“It is what it is. The anecdotal evidence of Vietnam veterans dying and getting diseases earlier is enormous,” said an exasperated Richard Weidman, an Army medic in the war and now legislative director for Vietnam Veterans of America. “I know five people in the VVA leadership alone who have been diagnosed with Parkinson’s. In no other side of my life have I seen anything like that.”

Yet for many who saw Vietnam firsthand, a 1-to-4 ratio of service-connected disabilities for Agent Orange strains credibility. And this is especially the case when the top conditions are heart disease and diabetes, two illnesses so linked to diet and lifestyle.

“Heart disease is a common phenomenon regardless of potential exposure to Agent Orange,” wrote Sen.Jim Webb (D-Va.) in a June letter to Shinseki challenging the secretary’s decision. A decorated Marine infantry officer in the war, Webb has since softened his tone after catching heat for his stance. But with his urging, the Senate Veterans Affairs Committee has scheduled a hearing Sept. 23 on the new regulations, slated to take effect by December.

“I just want to understand the logic of how they decided this latest service connection,” said Webb. “This is a helluva awkward position to be in where I’ve been an advocate all my adult life on veterans’ benefits. I just want to know how they got to this point.”

Backing Webb is Anthony Principi, also a Vietnam veteran, and the VA secretary under President George W. Bush.

“He’s gotten some heat, but how can anyone question his patriotism and what he has done?” Principi said of Webb. “It’s got to be looked at; it’s got to be addressed. ... This is serious. The numbers are dramatic.”

“We’re 40 years later and we need to ask, is there a better way to do this? You want to do what’s right for veterans,” he told POLITICO. “At the same time, you want to protect the integrity of the disability compensation program.”

The convergence of cost pressures now is striking as captured by events on Tuesday this week.

That morning, the VA expects the Federal Register to publish the new Agent Orange rules to implement the latest expansion of benefits, including heart disease coverage. And that evening, President Barack Obama will speak to the nation on the U.S. transition between Iraq and Afghanistan, two fresh post-Vietnam wars with their own legacy of new disability claims.

In fiscal 2005, the annual cost of VA’s compensation obligations was $28.6 billion; for fiscal 2011, the number’s $48.8 billion — a $20.2 billion or 71 percent increase.

Still more worrisome is the government’s long-term unfunded liability, a number tucked away in VA’s annual financial reports. The latest for Sept. 30, 2009, shows an unfunded liability of $1.32 trillion for VA’s compensation and pensions account. That’s up almost $400 billion from $924 billion in a matter of five years.

Yet for many Vietnam veterans, now in their 60s and approaching retirement, the tax-free disability payments represent a valuable supplement to Social Security.

In the case of ischemic heart disease, VA is assuming that most claims will be treated as a 60 percent disability, which translates into about $1064 per month for a married veteran. If the same veteran were already on 20 percent disability for diabetes, the payment could be $1,333 or almost $16,000 annually.

The VA calculates that IHD claims will account for three-quarters — about $31.2 billion — of the 10-year costs associated with the latest expansion. Disability percentages are typically lower for diabetes, but the sheer number of claims — more than 239,000 since 2002 — dwarfs all others before heart disease was added.

For example, prostate cancer generated about 57,300 claims in the same period by VA’s count; lung cancer less than 11,600 and non-Hodgkin’s lymphoma half that again.

Congress will have 60 days to review the regulations put forward by Shinseki, but lawmakers already approved a $13.6 billion down payment to cover retroactive claims related to the secretary’s ruling. And with November’s election around the corner, no one expects a major rollback.

“The horse is out of the barn, it’s a mess.” said one outside scientist who has worked with VA on Agent Orange claims. House Veterans Affairs Committee Chairman Bob Filner (D-Calif.) would go even further, extending the same disability benefits to thousands more veterans, such as “blue water” sailors who served on ships off the Vietnam coast.

“We owe this. It’s like a debt in my opinion,” Filner told POLITICO. “My motto is if you were there, we care.”

Indeed few topics touch more raw nerves at once: the bitter history of the Vietnam War, the often bad treatment of soldiers returning and the military’s early refusal to come to grips with the health impacts of its unprecedented use of the herbicide.

Agent Orange, which got its name from the orange-colored band on the storage barrels in Vietnam, was the most common of several dioxin-contaminated herbicide blends employed in Indochina over an almost 10-year period during the war. Literally thousands of tons were sprayed by the U.S. to try to destroy the jungle canopy and mangroves but also to clear tall grasses around American fire support bases.

It follows that exposure was greatest for those assigned to the spraying or in combat infantry units on the ground underneath — a fraction of the total U.S. force. But after a period of denial, the government gave up sorting out military records and said any veteran who put “boots on the ground” in Vietnam from early 1962 to May 1975 would be presumed exposed.

“Do you deny the deserving, or do you include in the presumption those people who may not have been exposed?” adds Dr. Victoria Cassano, a senior VA official dealing with environmental agents and Agent Orange. “The greater evil is to deny people who deservedly should be compensated for diseases because of this exposure.”

But Principi admits he still struggles with his role in what proved a sea change in policy, adding Type 2 diabetes to the list of presumed Agent Orange disabilities. The regulations were among the first order of business on his desk when he arrived in 2001, and from his war experience and prior service in VA, the new secretary brought with him an emotional tie to the late Adm. Elmo Zumwalt, who commanded Navy swift boat forces in Vietnam and watched his own son — a Navy Vietnam veteran as well — die of a cancer that the father attributed to Agent Orange exposure.

“It puts secretaries in a very untenable position,” Principi said. “I didn’t really care about the cost, our responsibility was to take care of veterans. But at the same time, I wanted to make sure the science was there and I just struggled with it.”

In fact, there’s a real disconnect between the outside scientists who advise the VA and the decision makers themselves. Congress can be faulted for the loose standard of proof it set in the 1991 Agent Orange Act to guide the process. But without more science — especially studies of veterans themselves — the integrity of the disability process is vulnerable to attack.

The chief outside actor is the Institute of Medicine within the National Academy of Science. Every two years since the mid-90s, IOM has produced detailed reports — volumes as thick as 682 pages with recommendations and updates of what scientists worldwide have learned relevant to Agent Orange’s impact.

Over time, these reports have led to a steady expansion of the diseases presumed to be associated with exposure to the herbicide. But often IOM and the VA seem to talk past one another as to what the science means.

“You are asking for the balancing of two different value systems, to come up with an answer and address a harm done to a person,” said Dr. Jeanne Stellman of Columbia University who has done extensive research on Agent Orange. “How do you translate science into law and policy?”

“The decision is very easy if it says no or if it says absolutely. In between is when there is imprecision,” said Dr. Robert Jesse, VA’s principal deputy undersecretary for health. And that comes often comes back to this question: What does IOM really mean when it says there is “limited or suggestive evidence of an association” between a disease and exposure to Agent Orange?

To hear IOM tell it, the category was never meant to be all decisive but more of a middle niche: “Something might be emerging here, something to keep an eye on,” one scientist told POLITICO. Along the same lines, a special IOM panel in 2008 went back and looked at the 2001 decision on diabetes and argued that the VA would have done better to test the association against “high-quality data for a representative cohort of veterans.”

VA officials answer that they are bound by the legal construct of the 1991 Agent Orange Act, which requires the secretary to respond within 60 days to any evidence of a positive association cited by IOM — however tentative.

“We can’t dismiss it,” said Cassano. “We have to take it as a positive association even though it states it as the lowest level of a positive association. We have to consider it credible.”

Asked if she were comfortable, as a scientist, with an end result where one in four Vietnam veterans could soon be getting service-connected Agent Orange disability payments, Cassano didn’t back down.

“Yes,” she said flatly. “We are comfortable with it; it is the right thing to do; it is the legal thing to do. ... When you are working in the VA and you have statutory requirements and basically a directive, a mission to be advocates for veterans, you are therefore bound by those parameters, and it really doesn’t matter much what outside scientists say.”

A closer look at Shinseki’s decision on IHD illustrates some of these conflicts.

It was a 14-member panel for the IOM, which set the ball rolling in its 2008 update, released last year. A similar panel in 2006 had been divided on the heart disease question, but after revisiting the question, IOM elevated the illness to the category of “limited or suggestive evidence of association.”

That decision was driven in part by newly published evidence showing a dose-response curve: the greater the exposure to Agent Orange, the greater occurrence of heart ailments. “When you see a dose-response curve, then you are much more inclined to be thinking causal,” said Jesse.

The VA had contributed an important piece with a 2006 study analyzing the incidence of heart disease among Vietnam veterans who had served in the Army Chemical Corps. And Shinseki, who himself served in Vietnam, found that this built on well-established evidence that dioxins present in Agent Orange could damage blood vessels. “Veterans who endure health problems deserve timely decisions based on solid evidence,” he said.

Nonetheless, the leader of the IOM panel, Dr. Richard Fenske of the University of Washington, told POLITICO that he was “surprised by the speed” with which the VA decided to add the presumption for heart disease. And Weidman argues that the department repeatedly ignores what he sees as a central tenet of the 1991 law: that more should be invested in scientific studies of veterans themselves.

“The whole concept of the 1991 law was to leave it to science, not politics, but we haven’t invested in the science in the 20 years since,” he said. In a shot back at Webb, he adds: “If you want more scientific data, fund the damn science.”

For all the debate over Agent Orange, what’s most surprising is how little or no effort has been made to track down specific infantry units that operated in the widely sprayed areas of Vietnam.

Instead, decisions are more often dependent on extrapolating data from studies of other populations: European and Asian chemical and agricultural workers, for example. The VA study of the Army Chemical Corps stands out for at least being Vietnam-centric. But even here, the focus did not include the great many more ground troops who were not involved in the actual spraying.

With so many claims on file now, the VA could yet work backward, identifying what units veterans served with in the war and their location in respect to the spraying. “The associations may be very much stronger if we really had the proximity data of where people served,” Jesse said. But to his frustration, Weidman has found that the VA’s health data is kept in a manner where this is not easily searchable. “They don’t want to know,” he said.

The biggest new effort is an old one: After almost a decade of delay, the VA is preparing to make another run at the long-promised National Vietnam Veterans Longitudinal Study to take a broad view at lasting health problems. A contract is expected to be awarded this fall, and, if successful, this could be the broadest assessment of ongoing Vietnam veteran health problems since the late '80s.

But the more lasting impact of the Agent Orange experience may be on the treatment of future veterans — not Vietnam’s.

At the end of a long interview, VA officials perk up most when the subject turns to VLER — their new “virtual lifetime electronic records” initiative to track each future veteran’s health charts from enlistment to grave. Included would be data from the military as to what toxic threats a soldier might be exposed to; “We will be able to know what levels of exposure there were to chemicals,” said Cassano.

And did Agent Orange influence this?

“Oh, certainly it has,” she said.

NCCN Prostate Cancer Treatment Guidance, 2011

2011-01-06T13:45:00.000-08:00

Prostate cancer is the most common cancer in men, with lung cancer the second most common. Because of significant improvements in screening and early detection of prostate cancer over the past 30 years, the outlook for many men diagnosed with this disease has improved.

If you have been diagnosed with prostate cancer, you probably have many questions. How it is likely to be treated? What happens when treatment is completed? This overview, which is based on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for prostate cancer, will help you understand the treatments available for prostate cancer. Talk to your doctor about these options so that together you can decide on a treatment plan that is right for you.

BackgroundThe prostate gland lies just below the bladder and produces a fluid that forms part of the semen. Men older than 65 years, those with a family history of prostate cancer (especially if a brother or father has been diagnosed with prostate cancer), and those of African descent are at higher risk for prostate cancer.

Screening for Prostate CancerMany men are choosing to be screened for prostate cancer using prostate-specific antigen (PSA) testing and digital rectal examination (DRE). The decision about whether to be screened is personal, but it should be based on an understanding of the potential risks and benefits of screening. Risks include discomfort, the possible side effects if a biopsy is done, and the physical and mental implications of finding out you have a cancer that may not pose a threat to your life. Benefits include finding prostate cancer at its earliest and most treatable stages.

Experts estimate that deaths from prostate cancer have decreased 40% since PSA testing became widespread in 1992. At the same time, there is a lot of disagreement about the value of early diagnosis with PSA testing. This is because many of the cancers found with screening will probably never pose a threat to a man’s life. Therefore, some men may undergo treatment that has no benefits to their life expectancy---in other words, these men will live as long as they would if they did not have prostate cancer, and the side effects of treatment could decrease their quality of life.

Prostate cancer often can be present for a long time before any symptoms appear. However, some aggressive and life-threatening cancers will be found through screening and therefore will be treated before they can spread. The greatest benefits of screening are for men at high risk for prostate cancer either because of family history or African-American descent. Benefits of screening are also most significant in men younger than 70 years.

Diagnosis of Prostate CancerProstate cancer rarely causes any symptoms until it is advanced and usually incurable. However, prostate cancer may be suspected for several reasons, including:

A lump in the prostate gland or an asymmetric prostate
Inability to pass urine
Difficulty starting or stopping the urine flow
Need to urinate often, especially at night
Weak flow of urine
Urine flow that starts and stops
Pain or burning during urination
Difficulty having an erection
Blood in the urine or semen
Frequent pain in the lower back, hips, or upper thighs
Suspicious findings from a DRE or PSA test do not necessarily mean that a man has cancer, and the symptoms above are not always caused by cancer (they can also be caused by a noncancerous condition called benign prostatic hyperplasia, or BPH.

To determine whether symptoms or an abnormal DRE or PSA results are caused by benign enlargement or prostate cancer, the doctor will perform a biopsy, often called a transrectal biopsy, under ultrasound guidance. In this procedure, the prostate is viewed using a probe the size of a finger inserted in the rectum. Tissue is removed with small needles from many areas of the prostate and examined under a microscope to look for cancer cells. This is the only way to specifically diagnose prostate cancer; an elevated PSA or abnormal DRE does not necessarily mean you have prostate cancer.

More Testing
If the biopsy indicates that you have prostate cancer, tests may be done to find out how aggressive the cancer may be. You may be scheduled for tests that will help your doctor determine whether your tumor is confined to the area where it began (that is, it is localized) or whether it has spread (that is, it has metastasized). Your doctor also will take a detailed medical history and may request other tests to determine your health and whether certain treatments are appropriate for you.

More tests may be ordered depending on how large the tumor is, your PSA level, and the Gleason score of your tumor. The Gleason score or grade is scaled to the aggressiveness of the prostate cancer. The Gleason grade is determined by a pathologist using a microscope to examine your cancer; it reflects the ability of the cancer to form glands. Generally, the lower the score, the more likely the tumor is growing slowly and the less likely it is to spread.

Additional tests may include:

A radionuclide bone scan to see whether cancer cells have spread to the bone
Magnetic resonance imaging (MRI) and/or computed tomography (CAT or CT scan) to show detailed images of the insides of the body
A pelvic lymphadenectomy, which is a surgical procedure to remove lymph nodes in the pelvis to see whether cancer has spread to these nodes
Each of these procedures provides information about grade and characteristics of the cancer that is important for determining the stage of your disease. Knowing the stage of your disease, in turn, is vital to determining which treatment program promises the best results.

Staging of Prostate Cancer A formal system called staging is used to identify how localized or widespread your cancer is. Prostate cancer stages range from stage I (most localized; cancer cells are only in the prostate) to stage IV (cancer cells have spread to distant lymph nodes and/or organs in your body, including the bones).

Staging is an important part of developing the best treatment plan for you.
For a more detailed discussion of staging, see the Cancer Staging Guide.

An elevated Gleason score and an elevated PSA level indicate that the cancer is likely to spread and that there is an increased chance that it might recur (come back) after treatment. This risk (or chance) of recurrence is another important factor in making treatment decisions.

Risk of Prostate Cancer Recurrence The risk that cancer may recur after treatment is a significant consideration in the treatment decisions patients make with their doctors. Many factors influence the risk that prostate cancer might recur. Among the most important are the size and location of the tumor; the PSA level in your blood; how fast the cancer cells are growing; and how far, if at all, the cancer has spread from the place where the tumor began. Many prostate cancers, especially in older men, are relatively slow-growing and may not have an impact on their lifespan or general health. Others, however, are quite aggressive and can spread to the bones and vital organs.

In recommending a treatment for you, your doctor will estimate how long you likely would live if you didn’t have prostate cancer based on your age and general medical condition (this is much the same process an insurance company uses in determining life insurance rates). Then, based on factors specific to your tumor, he or she will estimate how long it would take for your prostate cancer to become life-threatening to you. These two time periods are compared to help decide whether the prostate cancer is likely to reduce your lifespan and whether treatment is recommend.

Your doctor will review the results of your PSA test (and PSA tests that you had in the past, if any) to help determine how quickly your cancer is growing. The PSA level at the time your cancer is discovered is an important indicator. Generally, higher values indicate more aggressive cancer.

Additional important information may be obtained from the length of time it takes for your PSA value to double. For this “doubling” test to be valid, you must have had three separate PSA tests over a period of at least 18 months. In general, the faster the doubling time, the more aggressive the cancer. Some men with early-stage prostate cancer will have had enough tests over time for the doctor to compute this doubling time, but many will not have had enough PSA tests.

In addition to assigning a stage as described above, your doctor will also assign a Gleason score for your disease. This score, which ranges from 2 to 10, is a measure of the aggressiveness of your tumor. The pathologist assigns a number from 1 (least aggressive) to 5 (most aggressive) to the most frequently occurring appearance of cancer cells in the tissue sample used in the biopsy and the next most frequently occurring appearance of cancer cells in that tissue sample—this second sample is also assigned a score ranging from 1 to 5. The two scores are added together to get the Gleason score. The higher the score, the greater the chance that the cancer will (or already has) spread.

Based on your PSA level, cancer stage, and Gleason score, your doctor will estimate how likely the cancer is to grow and spread. Because all treatments for cancer can cause side effects, doctors aim to give patients treatments that will cause the fewest side effects while effectively curing the cancer. In some cases, the risk of the cancer getting worse may be relatively small compared with the side effects of treatment. However, when the risk is high that the cancer will grow quickly or recur after treatment, doctors may prescribe aggressive treatment to reduce that risk.

Treatment of Prostate CancerThe effectiveness of treatment depends on how localized the cancer is and whether or how far it has spread in your body. Depending on the stage of your disease and the other indicators discussed above, the characteristics of your tumor, and your age and general health, your doctor will recommend one or more of the following: active surveillance (also called observation, expectant management, or watchful waiting), surgery, radiation therapy, hormone therapy, chemotherapy, or targeted therapy. These options are discussed in the treatment summaries for localized prostate cancer and advanced prostate cancer.

Because some forms of prostate cancer treatment can cause infertility, if you want to father children you may want to discuss sperm banking before treatment begins. Your doctor can help you with this consideration.

Life After Prostate Cancer Treatment After completion of your treatment, you will begin a period called follow-up. During this period, you will visit your doctor at regular intervals. The doctor will perform a physical exam, ask you about how you are feeling, and order tests to make sure that you remain healthy and that any long-term effects of your prostate cancer or its treatment can be addressed. See Taking Care of Follow-Up Care.

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2010-12-29T08:29:00.001-08:00

http://prostatecancerinfolink.net/2010/12/29/second-study-confirms-data-on-p
sadt-and-survival-post-surgery/

* Only PSA doubling time (™9.0 months vs 3.0-8.9 months vs < 3.0
months) remained independently predictive of overall and/or metastasis-free
survival in multivariate analysis.

The authors note that - based on this data set - overall and metastasis-free
survival "can be extensive for men with PSA-recurrent prostate cancer, even
in the absence of further therapy before metastasis."

In other words, men with a PSA doubling time > 9 months after initial
biochemical failure have a high probability of long-term metastasis-free
survival, which may call into question the value of any form of second-line
therapy until there is clear evidence of the presence of metastatic disease.

Link is also available on the VPCC Facebook page.

Abiraterone Acetate Update

2010-12-21T09:49:00.000-08:00

Marketing application also submitted to European Health Authorities
HORSHAM, Pa., Dec. 20, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate. Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.

Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.

Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.

Data from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.

"These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company," said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. "We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients."

If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.

About Metastatic Advanced Prostate Cancer

Prostate cancer is considered to be advanced when metastases beyond the prostate occur and when resistance emerges to conventional hormonal therapies. Metastatic advanced prostate cancer is also referred to as castration-resistant prostate cancer, or CRPC, when disease progresses despite conventional hormone therapies or appearance of new metastases.

Prostate cancer occurs when cancer cells form in the tissues of the prostate. The prostate is a gland located around the urethra (under the bladder) in men that produces part of the seminal fluid. In some cases, cancer of the prostate can grow slowly compared with other cancers. However, depending on factors including characteristics specific to the patient and the tumor, prostate cancer can also grow very quickly and spread widely.

Prostate cancer is the second most common type of cancer in American men. One in six men will be diagnosed with prostate cancer, and in the United States in 2009, nearly 200,000 men were diagnosed with the disease. In 2010, an estimated 217,000 new cases of prostate cancer and 32,000 related deaths are expected to be reported in the United States.

About Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care. For more information about Centocor Ortho Biotech, visit www.centocororthobiotech.com.

About Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.

More information can be found at www.janssen-emea.com.

About Johnson & Johnson Pharmaceutical Research & Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com.

About Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.

Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., partners with affiliated units and companies in the Janssen Pharmaceutical Companies of Johnson & Johnson, such as Centocor Ortho Biotech Inc. and J&JPRD, in the research and development of oncology and supportive care treatments.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International or Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

*Editor's Note: J&JPRD has initiated an early access program (EAP) for abiraterone acetate in metastatic advanced prostate cancer patients who have exhausted currently approved treatment options including docetaxel and are likely to benefit from the therapy. For information about early access to abiraterone acetate, please call 1-800-457-6399.

Aspirin Therapy and Seniors'\Sexual Activity

2010-12-07T07:01:00.000-08:00

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Physician's First Watch for December 7, 2010
David G. Fairchild, MD, MPH, Editor-in-Chief

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Poll results are in!

Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis

Sex Remains Important to Many Elderly Men

NIH Issues Guidelines on Managing Food Allergies

Featured in Journal Watch: Suicide Attempts in the Population — What Counts?

Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis

Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.

Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)

Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).

In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation.

Lancet article (Free abstract)

Physician's First Watch coverage of study showing link between low-dose aspirin and reduced colorectal cancer risk (Free)

Sex Remains Important to Many Elderly Men

Roughly half of elderly men consider sex to be at least somewhat important to them, according to an Annals of Internal Medicine study.

Some 3000 community-dwelling men aged 75 to 95 in Australia completed questionnaires about sexual activity and health conditions. (The men also underwent sex-hormone measurement several years earlier.)

Among the findings:

Overall, 30% reported having sex in the previous year; the prevalence was highest among the youngest men (40% among 70- to 79-year-olds vs. 11% among 90- to 95-year-olds).
Of those who reported being sexually active, more than half were satisfied with the frequency.
Independent predictors of not being active included a diagnosis of prostate cancer, osteoporosis, or diabetes; antidepressant or beta-blocker use; and lack of interest or physical limitations of one's partner.
Higher free testosterone levels were associated with increased odds of activity.

Annals of Internal Medicine article (Free abstract)

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2010-12-01T12:03:00.000-08:00

Prostate Cancer Roundtable Optimistic that ODAC will Recommend Approval of
Dutasteride for Prostate Cancer Prevention

Washington, DC, November 30, 2010 – On Wednesday, December 1, the U.S. Food
and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
will hear presentations about the effectiveness and safety of dutasteride in
reduction of the risk for prostate cancer in men at greater than average
risk of such a diagnosis – and then decide whether to recommend approval of
dutasteride for this new indication.

Speaking on behalf of the entire Prostate Cancer Roundtable, Dan Zenka, a
vice president of the Santa Monica-based Prostate Cancer Foundation, said,
“We are optimistic that ODAC will send a strong signal to the FDA that the
benefits of dutasteride as an agent for the prevention of prostate cancer
far outweigh the known side effects of this agent. Dutasteride is a drug
that has been widely used for many years by hundreds and thousands of men as
a treatment for benign prostatic hyperplasia.”

The ability to significantly reduce lifetime risk for selected forms of
cancer is dependent, in part, on our ability to develop and bring to market
agents that can clearly reduce that risk -- in the same way that
cholesterol-lowering agents have been able to reduce risk for certain types
of cardiovascular disease. To date, only two drugs have ever been approved
for the prevention of any form of cancer -- tamoxifen and raloxifene -- each
of which is approved for the reduction of risk from invasive forms of breast
cancer in well-defined patient types.

“It is important to note that prostate cancer can have a devastating effect
on entire families,” said Theresa Morrow of Women Against Prostate Cancer.
“Just a little encouragement from a spouse or another family member can get
a man to his healthcare provider for regular health checks, including
prostate cancer testing when appropriate. The approval of a drug that can
help to reduce risk for prostate cancer would be another positive message in
the continuing battle to improve men’s health.”

The 8,200-patient REDUCE trial was a double-blind, randomized,
placebo-controlled, multi-center study that evaluated whether dutasteride --
at a daily dose of 0.5 mg -- decreased risk of biopsy-detectable prostate
cancer by comparison with a placebo. The patients tested in the REDUCE trial
were men between the ages of 50 and 75 who were at increased risk for
prostate cancer because of prostate specific antigen (PSA) levels between
2.5 and 10 ng/ml (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL
(in men aged greater than 60 years).

Results from the REDUCE trial were initially presented at the annual meeting
of the American Urological Association in April 2009 and subsequently
reported in the New England Journal of Medicine. They showed that
dutasteride lowered the relative risk of developing prostate cancer by 23
percent in men with an increased risk of the disease. The absolute reduction
in risk for a diagnosis of prostate cancer associated with dutasteride as
compared to a placebo was 5.2 percent.

The REDUCE trial clearly achieved its primary endpoint and demonstrated that
dutasteride significantly reduced the risk of biopsy-detectable prostate
cancers over a period of just 4 years. A total of 1,516 cancers were
identified among the 6,729 men who underwent a biopsy or prostate surgery,
with 659 in the dutasteride arm and 857 in the placebo arm.

“The approval of dutasteride for the prevention of prostate cancer
represents an important opportunity for men known to be at elevated risk for
this disorder,” said Tom Kirk, president of Us TOO International, the
world’s largest, patient-focused, prostate cancer education and support
network. “It may only be a first step toward the development of more
effective and even safer agents for the prevention of this disease, but it
would further validate the concept of chemoprevention for men at risk of one
of the most common forms of cancer, thereby encouraging continued research
into newer and potentially better agents for the future.”

As prostate cancer continues to strike one in six American men, and with
African American men having an incidence rate up to 60% higher than white
men, it is important that patients and their physicians engage in a
meaningful conversation about prostate cancer, about individual risk for
this disease, and about the value of prevention, early detection, and
appropriate management.

Wendy Poage, president of the Prostate Conditions Education Council stated,
“I cannot over-emphasize the importance for men to engage in an ongoing
dialogue with their healthcare providers about their individual risk for
prostate cancer and the need for appropriate baseline and follow-up testing.
It could mean the difference between living with or dying from this
disease.”

About Prostate Cancer

Prostate cancer is the most prevalent form of cancer among American males.
Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about
32,000 will die from this disease. Risk factors for prostate cancer are
known to include race, family history, elevated PSA levels, positive
findings on a digital rectal examination, and selected pathological findings
on prior biopsies.

About Dutasteride

Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under
the brand name Avodart. Dutasteride has previously been approved in the USA
and other countries around the world for the treatment of moderate-to-severe
symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged
prostate. When used in the management of BPH, dutasteride has been shown to
improve urinary tract symptoms, to reduce the risk of acute urinary
retention, and to lower risk for surgical intervention to resolve symptoms
of BPH.

Dutasteride, like all other prescription medicines, is known to be
associated with some common and some rare side effects. Common side effects
of dutasteride (occurring in less than 5% of patients) include impotence,
decreased libido, difficulty with ejaculation, and tenderness or enlargement
of the breast. Dutasteride is also known to trigger a rare allergic
reaction. Signs of this allergic reaction include a skin rash, hives, and
swelling of the eyelids, face, lips, arms or legs.

In the REDUCE trial, men receiving dutasteride had an increased incidence of
heart failure (30 events or 0.7 percent) compared to men receiving placebo
(16 events or 0.4 percent).

About the Prostate Cancer Roundtable

The Prostate Cancer Roundtable is a group of independent, not-for-profit
organizations which cooperate to foster the development of policies
supporting the prevention and early detection of clinically significant
prostate cancer, the effective treatment of men with this disease, and the
appropriate education of all men at risk for this disease.

###

The above statement has been issued on behalf of and endorsed by

American Urological Association Foundation

Cancer Survivor Bob Whitesel on Provenge treatment

2010-11-14T14:08:00.000-08:00

Commenter: Whitesel, Robert
Date: 07/29/2010
Comment:
Autologous cellular immunotherapy Is it "reasonable and necessary" under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act? My name is Robert Whitesel. [PHI Redacted]

[PHI Redacted] Autologous cellular immunotherapy seems more "reasonable" to me than other Medicare accepted prostate cancer therapies, e.g., radical prostatectomy and chemotherapy. To treat aggressive, advanced cancers, to be sure, it would seem to me at least as "necessary" as the aforementioned therapies already accepted as reasonable.

I wish to make three (3) points in support of my affirmative response to the question above:

[PHI Redacted]
2. It is important to minimize treatments with destructive side effects. Quality of life suffers and the patient's immune system may be weakened and left vulnerable to other diseases. This therapy has been designed to build on the immune- system-boosting-capability of GM-CSF (granulocyte macrophage-colony stimulating factor) agents and doesn't leave one's immune system compromised by the destructive effects of taxane-based chemotherapy agents.

3. Some way must be found to reduce the cost of this out- patient-administered therapy. Long-term costs could be reduced by treating the largest possible number of qualified patients early in their disease progression, thereby putting the cancer cells at least into dormancy and reducing or eliminating the subsequent need of today's similarly costly and less-effective treatments for these men.

Urologist Dr Mark Scholz on Provenge as Treatment

2010-11-14T13:59:00.000-08:00

Dear CMS Reviewers,

As an oncologist who specializes in treating
prostate cancer patients, I was extremely pleased
when the U.S. Food and Drug Administration
approved Provenge for the treatment of
metastatic, castrate resistant prostate cancer as
it represents an important advancement not only
in the treatment of prostate cancer, but the
beginning of a new treatment paradigm for the
treatment of all cancers.

I have used Provenge in my practice and continue
to be impressed by the ease of administration
with the treatment, as well as the almost total
lack of side effects experienced by patients. As
someone who has worked with prostate cancer
patients for nearly 20 years, I am all too
familiar with the difficult issues that patients
sometimes face with other treatments. Provenge
marks a new chapter in how I am able to treat my
patients, one that offers an improved survival
benefit, as well as an extremely mild side effect
profile and treatment duration when compared to
other treatments, such as chemotherapy. The
limited toxicity is so critical in maintaining a
good quality of life in these elderly ,
testosterone deprived individuals.

In addition to my clinical work, I am also the co-
founder and executive director of the Prostate
Cancer Research Institute, a non-profit
educational and research institute the focuses on
disseminating state-of-the-art information about
the diagnosis, staging and treatment of prostate
cancer. Provenge’s availability provides
healthcare professionals, as well as the patients
we treat, with a long-awaited and much-needed
alternative therapy for one of the neediest
patient populations in the prostate cancer
community.

There is a great deal of excitement among the
prostate cancer community to have a new and
effective treatment in the form of an
immunotherapy. I firmly believe that CMS has a
duty to both patients and their healthcare
providers to fully reimburse Provenge for the
indication in which it was approved, ensuring
that patients who have long awaited a new
treatment option to help them in their battle
with prostate cancer will have access to it. I
ask you, as a physician and an advocate for the
prostate cancer community, please do not delay or
inhibit access to Provenge.

Mark Scholz, M.D.
Medical Director of Prostate Oncology
Specialists, Inc., Marina Del Ray, CA
Associate clinical professor at the University of
Southern California School of Medicine
Co-Founder and Executive Director of the Prostate
Cancer Research Institute

Medical Phyicist Robert Baker to MEDCAC on Provenge

2010-11-14T13:32:00.000-08:00

View Public Comment for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)

Commenter: Baker, Robert
Title: Consultant, CEO
Organization: RJB Consulting
Date: 07/14/2010
Comment:
I am a Medical Physicist (Ph. D., licensed by the
American Board of Radiology), and have worked in
the medical field for more than 35 years. My role
always involves patients being treated with
radiation, e.g. from a linear accelerator treating
a cancer patient, or implanted radioactive seeds;
both of these techniques are often directed at
prostate cancer

I began my career in the early 1970’s, at the
University of California, San Francisco Medical
Center, (now a clinical trial center, with
researchers enthused about Provenge, and a very
long waiting list of patients!). Chemotherapy was
new and experimental then; Radiation Oncologists
began prescribing these new drugs (there were no
Medical Oncologists yet); doctors called them the
“telephone drugs”, because they had names like
Roche 7473. (These doctors also referred to them
as “poison”). Now we have enough of these drugs
to fill a phone book!

Then President Nixon declared the “War on
Cancer”. After several decades, and billions of
dollars had been spent on this “war”, I have heard
many of these same physicians say, in effect, “we
should just admit we have lost the war!” Cancer
incidence was up, not down, survival was not much
affected.

Since that time, we have had improvements in
treatment delivery involving radiation (IMRT,
Gamma Knife, Cyberknife, etc), but radiation’s
effect is explained statistically; radiation never
completely eliminates the tumor cells; it merely
reduces the tumor burden to the level that the
body’s own innate defenses can eradicate it.

The Holy Grail of Cancer research has always been
to activate the body’s natural defenses (the
immune system) to destroy the tumor. Provenge has
finally accomplished just this task, and as such,
it is the FIRST FDA approved product to do so!

Provenge has greatly reduced side effects,
compared to any and all chemotherapies. The
specific clinical trial leading to the final
approval of Provenge, involved patients with very
advanced stage prostate cancer, that had already
failed multiple other existing treatment regimens,
and in the majority of cases had already
metastasized; “compassionate use” allowed these
clinical trial patients in the Standard of Care
arm (Taxotere) to “cross over”, if they were
failing treatment under the standard treatment;
many did so (I believe the majority), and even
these were helped by Provenge, even though they
were provided the drug late, and with a preserved
(frozen) form of Provenge.

This is truly a remarkable accomplishment, a
dramatic result, and supporters of this product
believe (and there is evidence) that Provenge can
be even more effective when applied earlier and in
broader circumstances.

In summary: Provenge is a breakthrough,
disruptive, new, dramatic, life extending, quality
of life preserving, treatment, that should be made
available to all prostate cancer patients whose
doctors determine they will benefit!

New Biomarker for Prostate Cancer

2010-11-07T18:04:00.000-08:00

PROTEIN ARRAY ACCURATE
FOR PROSTATE CA
A panel of prostate cancer-derived
autoantibodies distinguished cancer
from benign prostatic hyperplasia and
healthy tissue with greater than 90%
accuracy, according to a preliminary
report from the 2010 American Association
for Cancer Research meeting.
The functional protein microarray had
similar accuracy for detecting cancer
(sensitivity) and for ruling it out when
used to evaluate noncancerous tissue
(specificity).
Prostate specific antigen (PSA) testing
also has a sensitivity of about 90% but a
specificity of less than 50%, John Anson,
PhD, said at a press briefing during
the American Association for Cancer
Research International Conference on
Molecular Diagnostics in Cancer Therapeutic
Development.
“What that means is there are lots of
potential false-positives,” said Anson, of
Oxford Gene Technology in the UK.
“What that translates to in clinical practice
is that a lot of men are going on for
unnecessary diagnostic procedures, such
as needle biopsies, and even radical
prostatectomy, which perhaps are not
required. Biomarker panels offer the
potential to significantly improve detection
of prostate cancer

Preventive Services Update

2010-10-26T12:50:00.000-07:00

Oct 26, 2010
The Wall Street Journal Health Blog: "The United States Preventive Services
Task Force has canceled a meeting set for early next month at which the
thorny issue of prostate-cancer screening was due for a vote. ... [W]hen
prostate-cancer screening came up last fall, the USPSTF initially voted to
recommend against screening for men of all ages before opting instead to
re-vote on the issue. . Currently the USPSTF has an 'I' rating for
prostate-cancer screening, which means the current evidence is insufficient
to assess the balance of benefits and harms, for men younger than 75. For
older men, the rating is 'D,' which means the USPSTF recommends against
screening. The group last issued recommendations in August 2008, but in
2009, results from two large screening trials were published. The studies
provided no clear answer of whether the benefits of screening outweighed the
harms" (Hobson, 10/26).

This is part of Kaiser Health News' Daily Report - a summary of health
policy coverage from more than 300 news organizations. The full summary of
the day's news can be found here and you can sign up for e-mail
subscriptions to the Daily Report here. In addition, our staff of reporters
and correspondents file original stories each day, which you can find on our
home page.

Important New PSA Research

2010-10-25T20:05:00.000-07:00

MONDAY, Oct. 25 (HealthDay News) -- Having a prostate-specific antigen (PSA) test to screen for prostate cancer reduces the risk that if cancer develops it will spread to other parts of the body, new research indicates.

The finding adds to the ongoing debate on whether PSA screenings actually improve survival rates or, by contrast, lead to unnecessary treatment.

"Our study shows that routine screening not only improves the patient's quality of life by stopping metastatic disease, but it also decreases the burden of care for this advanced disease that must be provided by the health-care system," study author Chandana Reddy, a senior biostatistician at the Cleveland Clinic in Ohio, said in a news release from the American Society for Radiation Oncology.

"This demonstrates that the PSA test is extremely valuable in catching the disease earlier and allowing men to live more productive lives after treatment," Reddy said.

Reddy and his colleagues are to report their findings Monday at the American Society for Radiation Oncology annual meeting, in San Diego.

PSA tests are blood tests that have been available and widely used since 1993. They measure levels of the prostate-specific antigen protein produced by the prostate; high levels are thought to be an indication of prostate cancer.

However, critics have cautioned that some patients diagnosed with early prostate cancer are subjected to aggressive treatments -- and their unwelcome side effects, such as incontinence and erectile dysfunction -- for a disease that is often slow-moving and of no real consequence to survival if left untreated among older patients who are likely to die of other, unrelated causes.

However, the researchers pointed out that prostate cancer is not curable when it is caught late and has spread (or metastasized) to other parts of the body. They suggested that assessing to what degree a PSA diagnosis might reduce the risk of metastasis could be the best way to determine the value of the test.

To that end, Reddy and his team analyzed data on more than 1,700 prostate cancer patients who between 1986 and 1996 had been treated with either radiation therapy or surgery to take out their prostate gland and the surrounding tissue.

Noting that in the first half of the study period, PSA tests were not yet available, the authors compared the spread of the disease over the course of 10 years among those who had been diagnosed with a PSA test and those who had not.

Over the 10-year period, metastatic disease took hold among 13 percent of all the patients. However the researchers found that regardless of whether patients were categorized as having high-, medium-, or low-risk disease, those who had been diagnosed as a result of a PSA screening were significantly less likely than those who weren't to have seen their cancer spread during the decade following their original treatment.

Dr. Lionel L. Banez, an assistant professor of urologic surgery at Duke University Medical Center, said that the current study leans toward the relative benefits of prostate cancer screening.

"There is compelling evidence that PSA testing saves lives, especially when performed in an optimized strategy," he said. "For example, getting an initial PSA measurement at age 40 to properly assess baseline prostate cancer risk has been proven to be quite beneficial.

Nevertheless, Banez acknowledged that doctors need to interpret test results judiciously.

"The challenge," he stressed, "lies in ensuring that the risks for over-diagnosis and over-treatment, as well as potential decline in quality of life, are minimized or avoided."

More

United Health Care Program to Cut Individualized Treatmnts

2010-10-20T13:13:00.000-07:00

UnitedHealthcare plans to announce on Wednesday a one-year project with five
oncology practices, offering doctors an additional fee. The new fee is meant
to encourage doctors to follow standard treatments rather than opting too
often for individualized and unproven courses of therapy, which can include
the most expensive drug combinations. By proposing a different type of
payment structure, companies hope to lower doctors' dependence on a system
that generates substantial sums for cancer specialists who routinely favor
top-of-the line treatments.

Regional insurers in some states, including California, Washington and
Pennsylvania, are negotiating similar limits with doctors and their clinics.
WellPoint, another large insurer, is developing a way of paying oncologists
to coordinate and manage patient care.

By almost any measure, cancer treatments can be exorbitantly expensive.
Cancer care in the United States costs almost $100 billion a year, and
medical bills for the average patient on chemotherapy can top $100,000 a
year.

http://www.nytimes.com/2010/10/20/health/policy/20cancer.html?_r=1&emc=eta1

What does this mean for forward movement with new treatments once they are
approved? Also are they considering anything other than cost? What about
QOL? Will this have an impact on the development of new treatments?

Kathy

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Vitam Update

2010-10-12T14:31:00.000-07:00

Knowing What’s Worth Paying For in Vitamins

CloseLinkedinDiggMixxMySpaceYahoo! BuzzPermalink By LESLEY ALDERMAN
Published: December 4, 2009
WHEN I stock up on ibuprofen (my painkiller of choice), I typically buy a 500-count bottle of a store brand like Kirkland or Rite Aid. After all, ibuprofen is ibuprofen. Each pill costs me about 3 cents — or only one-third the cost of 9-cent Advil.

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Chester Higgins Jr./The New York Times
A Vitamin Shoppe location in Manhattan. ConsumerLab.com found products sold by vitamin chains tended to be more reliable than drugstore brands.

Well
Share your thoughts on this column at the Well blog.

Sales over the last decade had been growing by about 4 percent annually. But this year, as more people are taking their health into their own hands, perhaps hoping to stave off doctor bills, vitamin sales are expected to grow by 8 percent to a total of $9.2 billion, according to Nutrition Business Journal, a market researcher and publisher.

About 42 percent of shoppers purchase their vitamins at natural and specialty retail outlets, like GNC and Whole Foods, according to the journal, while only 23 percent take the discount approach and buy their bottles at supermarkets and club stores. The other 35 percent buy through mail order or from a health care provider.

Of course, it’s controversial whether we should be taking vitamins at all. Recent studies have indicated that taking a multivitamin won’t protect you from heart disease or cancer. And experts maintain that if you eat well, you don’t need vitamin supplements.

“The evidence shows that a healthy diet and exercise are the best way to ward off disease; a vitamin cannot replace those benefits,” says Eric Rimm, associate professor of epidemiology and nutrition at the Harvard School of Public Health.

But what if you don’t eat well or are chronically stressed out? Then, Professor Rimm says, there may be some benefit from taking a multivitamin. “Certain subgroups, including women of child-bearing age attempting to get pregnant, may need specific supplements, like folic acid and omega-3,” he added.

As for the matter of cost: If you take only a daily multivitamin mainly as a medical insurance policy, it certainly won’t hurt your health — as long as you do not already eat a lot of fortified food. And it could help. But it will require spending some money. And if you take a multivitamin and a few individual vitamins and minerals, it’s even more worth your while to make sure you’re not paying more than you need to.

USE ONLY WHAT YOU NEED Popping too many vitamin pills is not only a waste of money but can be bad for your health. Talk to your doctor about what added vitamins or minerals you might require; you can ask for a blood test to learn what you might be lacking.

For example, if you don’t get enough vitamin D — many people who live in the northern states or who wear sunscreen everyday are low on this crucial vitamin — then buy just a D supplement. Standard multivitamins will probably not have the levels of D you require (many doctors suggest taking 1,000 to 2,000 international units a day).

If your doctor recommends a specific supplement, like omega-3, ask in what form you should be taking it.

FIND A REPUTABLE SOURCE Vitamins and minerals are commodity items, and every manufacturer has access to the same ingredients. For that reason, researchers and scientists say paying more for a name brand won’t necessarily buy you better vitamins.

“When we measure levels of vitamins in the blood, we find the levels are the same whether the person was taking a generic brand or a name brand,” says Dr. Rimm, who has been studying the effects of vitamins for 20 years.

That said, don’t be too cheap. Purchase your vitamins from well-known retailers that do a brisk business and restock frequently, whether that’s Costco or Drugstore.com. Vitamins lose their potency over time and must be stored at, or below, room temperature. If bottles are sitting on a shelf in warm room or in direct sunlight, they may degrade even before their expiration date.

PRICE MAY NOT MEAN QUALITY While the Food and Drug Administration regulates vitamins as part of the nutritional supplement industry, it does not test them before they are put on the shelves. The F.D.A. places the responsibility on the manufacturer to ensure that its dietary supplement products are safe before they are marketed. All of which means that no matter what the price, quality is not assured.

ConsumerLab.com, a company based in White Plains that tests hundreds of vitamins each year, finds that 30 percent of multivitamins have a quality problem: the pills might have more or less of a stated ingredient, or they might not dissolve properly.

Taking exception to such assertions is the vitamin industry’s trade group, the Council for Responsible Nutrition. In response to questions, the council released a statement from Andrew Shao, a vice president for scientific and regulatory affairs.

Mr. Shao said that the F.D.A. allowed for “a reasonable amount of variation” — which he characterized as up to 15 percent more of an ingredient than the label might indicate. Mr. Shao said that manufacturers frequently add slightly more of an ingredient to ensure that the amount is at least at the level claimed on the label as the product nears the end of its shelf life.

In any case, ConsumerLab.com says it has found a few patterns that consumers may find helpful. Products sold by vitamin chains tend to be more reliable than drugstore brands, and Wal-Mart and Costco’s vitamin lines are usually worth considering. In a recent test of multivitamins, ConsumerLab.com found that Equate-Mature Multivitamin 50+ sold by Wal-Mart was just as good as the name brand Centrum Silver, but at less than a nickel a day is half the price.

Puritan’s Pride, a catalog and online retailer, also has very good prices, and Dr. Cooperman says that its products are generally good.

Curious consumers can subscribe to ConsumerLab.com for $30 a year and learn how other supplement brands fare in the lab’s tests.

CERTIFICATION SYMBOLS One quality check you can make, although it is not a perfect screening, is to see whether a product is certified by one of several nonprofit organizations that check supplements for purity and quality.

The two most commonly used groups are the United States Pharmacopeia (www.usp.org) and NSF International (www.nsf.org), according to Mr. Shao. Manufacturers voluntarily submit a product for review and, if it passes, the product can bear an approval seal, such as USP or NSF. Because the process is voluntary, Mr. Shao points out, the absence of the seal does not necessarily mean the product is of poor quality.

But at least the seal should mean you know what you’re getting. And with vitamins, anything beyond that simple assurance may not be worth paying for.

Nanoparticle PSA Test Improves Detection

2010-10-07T15:07:00.000-07:00

Prostate Cancer Resources

Managing Bone Metastases and Pain

Side Effects of Prostate Cancer Treatment

Nanoparticle PSA Test Predicts If Prostate Cancer Will Return; Ultrasensitive Test Gives First Accurate Answer After Surgery
by Alton Parrish | BeforeItsNews.com | 06.02.2010
Men who have just had their cancerous prostate gland removed have one pressing question for their doctors: Am I cured? But conventional tests haven't been sensitive enough to provide a concrete answer.

Current tests that measure the level of protein called PSA (prostate-specific antigen), which signals the presence of cancer, often detect no PSA, only to have cancer return in up to 40 percent of the cases.

New research from Northwestern University Feinberg School of Medicine and the University International Institute for Nanotechnology shows that an ultrasensitive PSA test using nanoparticle-based technology (VeriSens™ PSA, Nanosphere, Inc., research-use-only) may be able to definitively predict after surgery if the cancer is cured long-term or if it will recur.

The new test, which is based upon assays invented at Northwestern in the laboratories of co-principal investigator Chad A. Mirkin, is 300 times more sensitive than currently available commercial tests and can detect a very low level of PSA that indicates the cancer has spread beyond the prostate. The test also may pick up cancer recurrence at a much earlier stage, when secondary treatment is most effective for a patient's survival.

"This test may provide early and more accurate answers," said co-principal investigator C. Shad Thaxton, M.D., an assistant professor of urology at Feinberg and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

"It detects PSA at levels in the blood that cannot be detected by conventional tests. It may allow physicians to act at the earliest and most sensitive time, which we know will provide the patient with the best chance of long-term survival."

This ability to quickly detect very low levels of PSA may enable doctors to diagnose men with prostate cancer recurrence years earlier than is currently possible. Prostate cancer is the second leading cause of cancer death for men in the United States.

Not only may the new test more accurately predict the course of the disease; it also gives an early indication of whether secondary treatments, such as radiation and hormone therapy, are working. If not, then doctors can quickly begin alternative treatment and refer patients to clinical trials.

The study results will be presented at the American Urological Association 2010 Annual Meeting. These and the results of other Northwestern PSA studies will be presented at the meeting by Lee Zhao, Dae Kim and Hannah Alphs, urology residents at Feinberg.

"These studies suggest that the nanotechnology PSA test might become the preferred postoperative PSA test for men who have been treated with radical prostatectomy," said William Catalona, M.D., professor of urology at Feinberg, a physician at Northwestern Memorial Hospital and director of the clinical prostate cancer program at the Lurie Cancer Center.

"It should be especially useful in the early identification of men who would benefit from adjuvant postoperative radiation therapy and those who need postoperative salvage radiation therapy for recurrence."

Catalona, a senior investigator on the study, was the first to demonstrate that the PSA test could be used as a screening test for prostate cancer.

The study confirms and builds on the previous findings of a 2009 pilot study Thaxton conducted with Mirkin, the George B. Rathmann Professor of Chemistry in the Weinberg College of Arts and Sciences, and other colleagues.

PSA is a protein normally secreted out of the prostate cells into the semen in high concentrations. Usually, very little diffuses into the blood stream, and the normal PSA value for men without prostate disease is less than 2 nanograms per milliliter.

When the prostate gland has a disease process, such as inflammation, benign enlargement or cancer, the barriers to PSA diffusion into the blood stream are breached, and PSA levels rise.

In a man who has his cancerous prostate removed, there should be no PSA in the blood except for a minute amount produced by the periurethral glands. However, any PSA produced by cancer recurrence ends up in the blood stream and can be detected earlier with the more sensitive nanotechnology PSA assay.

For the new study, researchers obtained blood serum retrospectively from men whose PSA serum samples had been frozen after surgery and whose assays (blood analysis) showed an undetectable PSA level based on the conventional test.

Northwestern researchers then tested those serum samples using the more sensitive nanotechnology-based test. They wanted to see if they could detect PSA at levels below the limit of the conventional test, and if those results could predict the cancer outcome for those patients, who were followed for up to 10 years.

Using the new test, Thaxton and colleagues found that the low and non-rising PSA levels (presumably produced by the normal periurethral glands) of patients meant that the prostate cancer was effectively cured and did not return over a period of at least 10 years. Scientists also found a PSA level higher than that expected from the periurethral glands based on the new test meant the patients would have their disease recur.

As result of the study, researchers were able to assign a PSA level number to a cure for the first time as well as a number that indicated the disease would recur and if it would recur aggressively.

These newly identified levels were below what could have been detected with the conventional PSA test. The researchers were able to quantify PSA values at less than 0.1 nanograms per milliliter, the clinical limit of detection for commercial assays.

Thaxton said the next step for scientists is a prospective clinical trial to compare the nanoparticle-enhanced PSA assay to traditional PSA assays and determine if earlier detection and treatment can save lives.

CMS Payment Coverage Debate over Provenge

2010-09-28T18:34:00.001-07:00

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Dendreon vs CMS: Why the Provenge Coverage Controversy Is Bigger Than Just One Product
by Ramsey Baghdadi | CancerNetwork.com | 09.22.2010
It appeared that the controversy surrounding the prostate cancer immunotherapy Provenge ended with FDA approval in April. But now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.
Is $93,000 beyond the upper limit of what a drug company can charge for a non-curative cancer therapy when the government is the primary payer? That may be one interpretation of a recent action by the Centers for Medicare & Medicaid Services (CMS) to review its coverage policy for Dendreon’s prostate cancer cell-based immunotherapy Provenge.

Although the looming fight between Dendreon and CMS appears to be specific to the product in question, there is a larger lesson for other biopharmaceutical companies, particularly those operating in cancer drug development: as the government becomes an increasingly large payer, it is paying closer attention to what officials may see as exorbitant pricing practices.

And CMS has the tools at its disposal to force a de facto price negotiation—or go down fighting.

At the very least, the case of Provenge serves as another reminder that there are two regulators in Washington—not one—that are critical in determining a product’s commercial success. Approval by the Food & Drug Administration (FDA) remains, of course, a defining milestone for biotech companies and their investors, but satisfying CMS can be just as critical, especially in the field of oncology where Medicare is the dominant payer.

CMS may end up covering Provenge without limitation, or it may end up putting restrictions on coverage that have no real impact on a product that is going to be in relatively tight supply for the near future. But simply by initiating the review, the agency is encouraging public conversation about the value of the therapy.

That certainly has the attention of investors—and may be a sign of things to come for the biopharma sector overall.

Provenge Clears One Regulatory Hurdle, Faces Another

It’s almost never a good thing when your drug is the topic of daily conversations at CMS. That’s exactly the situation Dendreon found itself in with Provenge.

Investors cheered when Provenge was approved by FDA on April 29. The stock price rose as the days grew closer to Dendreon’s user fee date for Provenge as investors correctly anticipated that the product would complete its turnaround from a devastating “complete response” letter sent three years earlier. Even after the run-up, the stock increased by almost 35% the day the approval letter was disclosed, bringing its year-to-date increase to 100%. All that on top of a 10-fold price increase in 2009.

It looked to be the successful end of a long, up-and-down journey for the biotech company. During a same-day conference call announcing the Provenge approval, CEO Mitchell Gold declared that Dendreon had found the “Holy Grail of oncology” and that the company would begin a rollout of Provenge the following week.

The price? $93,000 for a three-course cycle; or $31,000 per infusion…

Even though breakthrough oncology therapies typically can garner an attractive premium compared with drugs in other therapeutic areas, the high price surprised even the most bullish Provenge watchers who had been following the progress of the cell-based immunotherapy.

Would reimbursement be a problem at that price, especially considering approximately 75% of patients who will use Provenge are Medicare beneficiaries?

Dendreon anticipated that Medicare and private payors would cover the costs of Provenge, Gold said, and a company official noted that the prostate cancer therapy Taxotere cost roughly $60,000 for a full treatment, making it “very close” to Provenge. The company also highlighted the cost advantage of Provenge as a defined, three-course regimen rather than a more typical open-ended course of therapy.

In the end, the price, Dendreon said, represented and “advantageous cost/value structure.”

Moreover, Dendreon planned to rollout Provenge to only 2,000 patients in the first 12 months, translating to a $110 million cost—not typically a sum that grabs a lot of attention when it comes to the large Medicare program.

CMS Opens a National Coverage Analysis

However, CMS was paying attention.

In a shocking move, CMS announced on June 30th that it had opened a national coverage analysis (NCA) for Provenge to determine whether the therapy is “reasonable and necessary.”

The Medicare agency said specifically: “CMS opens this NCA for autologous cellular immunotherapy treatment of prostate cancer. CMS is requesting public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer…CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the subject under review. CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) in 2010.” The National Coverage Decision is expected in March 2011.

How big an impact did CMS’ announcement have? For Wall Street, it is simple: CMS’ decision to review coverage of the therapy erased all the gains from the approval of the product; with the stock dropping all the way back to the levels it had in January.

Put another way, investors seem to feel that the uncertainty surrounding the coverage policy means as much to the value of the company as did the uncertainty around FDA’s regulatory decision.

Using an alternative metric, based on Dendreon’s market cap of approximately $7.3 billion the day following FDA approval, Dendreon would have to give Provenge to more than 78,000 men with prostate cancer to meet the cap number. Following the CMS announcement, the number of prostate cancer patients dropped to just over 41,000 needed to meet the $3.9 billion market cap in early July.

And investors wondered: If CMS is taking on Provenge, will it take on other cancer therapies, like Roche AG’s Avastin, Herceptin and Rituxan?

The answer to that question is: it just might.

All indications are that the decision to review Provenge was triggered by specific circumstances surrounding what is, after all, a completely new type of therapy: a cell-based cancer “vaccine.” In that sense, it is probably an over-reaction to read into CMS’ decision a blanket review of coverage of all high-priced cancer therapies currently in use and in the pipeline.

But, having opened up the conversation in this specific context, there is nothing to stop CMS from expanding its reach and looking more broadly at what everyone in the healthcare policy world agrees is a key issue for the future: the exploding cost of cancer treatment in the U.S.

The Wrong Approach

It appears to have been a confluence of four factors that led to the NCA for Provenge: the price, Dendreon’s lack of communication with CMS, noise from private payers, and an agreement between FDA and CMS to facilitate the exchange of information.

First off, there are indications that CMS was unhappy that Dendreon did not talk with agency officials much earlier in the development and review process, given the certainty that Medicare would be the primary payer for the new therapy. During the April 29 conference call, Dendreon essentially admitted it was not focused on CMS early on, saying it planned to meet with agency officials the week of May 3 to discuss reimbursement issues.

The lack of communication is one thing; the pricing decision is another. After hearing the price set by Dendreon for Provenge, some CMS officials became concerned about the high cost. At that point, the immunotherapy began being discussed regularly at the agency.

At the same time, CMS was hearing concerns from medical directors at private insurers who were complaining about the sticker-shock price.

Almost serendipitously from CMS’ point of view, a memorandum of understanding (MoU) was signed between the Medicare agency and FDA “to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the federal partners.”

The MoU provides a framework for CMS medical experts and coverage analysis group to get full access to Dendreon’s study data of Provenge.

CMS’ decision to initiate an NCA may be nothing more than a back-door price negotiation.

It wouldn’t be the first time. Biogen Idec expected to get a payment code soon after launching its diagnostic/radiotherapeutic agent ibritumomab (Zevalin). The code was delayed for several months and then was set at 78% of Average Wholesale Price (AWP) as opposed to the much better rate of AWP-5%. Subsequently, Zevalin took another hit when CMS reclassified it as a procedure rather than a drug, giving it an even lower reimbursement rate.

What happened? CMS leadership became aware that Biogen had set Zevalin’s AWP at about $30,000 and communicated to the company that either there needed to be a price cut or Biogen could keep waiting for a coverage code. Eventually, the agency and Biogen were able to reach a compromise, but Zevalin never reached the commercial success that Biogen had hoped for.

CMS’ Options: Many or Few?

The Zevalin issue, however, took place outside of the “official” coverage process; with Provenge, CMS is going by the books, and that means there really isn’t much room for Dendreon to make an accommodation on price.

Here is how CMS officials see the options for a potential national coverage decision:

(1) Coverage

(2) Coverage with evidence development

(3) Coverage for on-label use only and blanket non-coverage for off-label use

(4) More restrictive coverage affecting even on-label use

(5) Blanket non-coverage

However, under the applicable Medicare statute, it appears as though CMS is relatively boxed in, and will have to cover, at the very least, the labeled uses of the therapy.

Sec. 1861(t)(2)(A) of the Medicare statute defines “drugs” to include “any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.”

The description under the law of a medically accepted indication: “includes any use which has been approved by the Food and Drug Administration for the drug and such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or the carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this sub-clause by the Secretary.”

Still, there is ambiguity about whether CMS could in fact deem an FDA-approved drug to be not “reasonable or necessary” despite the definition, and some officials within CMS believe the therapy should not be covered, citing skepticism over the study data used to support FDA approval.

If CMS were to attempt to move away from routine coverage of cancer drugs, it would indeed have dramatic implications for the biopharma sector and the scientific inquiry and development of novel cancer therapeutics.

Copyright CancerNetwork.com 2010

CMS Payment Coverage Debate over Provenge

2010-09-28T18:34:00.000-07:00

Using Finasteride Sor PCa Prevention?

2010-08-29T19:40:00.000-07:00

Few Doctors Prescribe Finasteride to Prevent Prostate Cancer, Despite Effectiveness
by Thomas H. Maugh II | Los Angeles Times | 08.11.2010
Most physicians are reluctant to prescribe the drug finasteride to prevent prostate cancer in older men with elevated risk of the disease, despite evidence that the drug can reduce risk by about a quarter, researchers said Tuesday.

"There are no other proven ways of reducing yours risk of prostate cancer -- this is the only one," Dr. Ian M. Thompson of the University of Texas Health Science Center in San Antonio, told Bloomberg. Its use could reduce new diagnoses by "tens of thousands," he said.

Thompson was the lead author of a 2003 report that showed that the drug, sold by Merck under the brand name Proscar, could reduce the risk of prostate cancer among such men from 24% to 18%. Another study earlier this year showed that a second drug, dutasteride, might be even slightly more effective.

About 217,730 men will be diagnosed with prostate cancer this year, according to the National Cancer Institute, and about 32,000 will die from it. That makes it the second-leading cause of cancer death among men, following only lung cancer.

Risk factors for prostate cancer include being over the age of 65, having elevated levels of prostate-specific antigen (PSA), a family history of the disease and being African American.

In the new study, Dr. Linda S. Kinsinger of the Veterans Health Administration National Center for Health Promotion and Disease Prevention and her colleagues surveyed a random sample of 325 VHA urologists and 1,200 VHA primary care physicians to determine how their prescribing practices changed from 2000 through 2005, a period that included the widely heralded finasteride trial.

The researchers reported in the September issue of the journal Cancer Epidemiology, Biomarkers & Prevention that the use of finasteride did increase somewhat during the period, but to treat benign prostatic hyperplasia, not to prevent prostate cancer. Fully 64% of urologists and 80% of primary-care physicians said they never prescribed the drug for prevention, and 52% of the latter group said they did not even know that the drug could be used for that purpose.

One concern among urologists was that the 2003 study suggested that, even though finasteride reduced the risk of prostate cancers, those who did develop the disease might be more likely to develop a highly aggressive form of the disease. Researchers have subsequently shown, however, that that was an artifact of the study and that the drug doesn't increase the risk of such tumors.

"The prospect of chemoprevention is a difficult one for patients and physicians," Kinsinger said in a statement. She compared using finasteride to ward off prostate cancer to using statins to ward off heart disease.

The primary difference between the two, she added, is that the effects of statins can be monitored by measuring cholesterol levels, but there is no analogous marker to show that finasteride is working. The only marker is not developing cancer.

The primary side effect of finasteride is that it increases hair growth. In fact, the drug is also sold under the brand name Propecia to promote new hair growth in the balding. The amount of drug in Propecia is about 20% of that in Proscar.

Copyright Los Angeles Times 2010

Initial Savings May Hide True Cost of Prostate Cancer Care
U.S. News & World Report | 08.23.2010

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National Cancer Institute's Clinical Trials

2010-08-27T11:13:00.000-07:00

Click Here for more information and links to surveys

Multiple trials

Prostate cancer trials at the NIH Clinical Center in Bethesda, MD [080706]

NCI currently conducting trials for patients with prostate cancer -- The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), conducts more than 150 clinical trials at the NIH Clinical Center in Bethesda, MD. NCI is currently conducting clinical trials for patients with prostate cancer.

Visit http://bethesdatrials.cancer.gov/prostate for a listing of prostate cancer clinical trials that are currently enrolling patients at the NIH Clinical Center.

There is no charge for medical care received at the NIH Clinical Center. Study participants will be responsible for travel costs for their initial screening visits. Once participants are enrolled in a trial, NCI will pay for the transportation costs for all subsequent trial-related visits for participants who do not live in the local area. In addition, these participants will receive a small per diem for food and lodging expenses if they are being treated as outpatients.

For more information on clinical trials conducted at NCI, please visit http://bethesdatrials.cancer.gov or call the Clinical Trials Referral Office (formerly Clinical Studies Support Center) at 1-888-NCI-1937 (1-888-624-1937).

The National Cancer Institute also sponsors clinical studies at cancer centers nationwide. To learn more about these studies, call 1-800-4-CANCER (1-800-422-6237).

Hormone refractory/hormone resistant PCa

2010-08-27T11:05:00.000-07:00

AFFIRM (A Study Evaluating the EFFicacy and Safety of Investigational DRug MDV3100 in Men with Advanced Prostate Cancer) [012010]

Now enrolling patients, this trial will evaluate the efficacy and safety of the investigational drug MDV3100 as a treatment for advanced prostate cancer – specifically a type known as hormone-resistant prostate cancer. The study will evaluate the impact of MDV3100 on survival and other factors, including quality of life.

The first triple-acting, oral anti-androgen, MDV3100 has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than the most commonly used anti-androgen, bicalutamide. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone from binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells and inhibits binding to DNA. Preclinical data published in Science demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

Patients who were previously treated with the chemotherapy drug docetaxel may be eligible for the study. Two-thirds of patients will randomly be assigned to receive MDV3100 while 1/3 will receive placebo (sugar pill), which does not contain active medicine.

For more information on eligibility and enrollment, patients can call the AFFIRM study hotline toll-free at 1-888-782-3256 or visit www.affirmtrial.com

Dr Patriclk Walsh on Selectiing Your Surgeon

2010-08-27T10:50:00.000-07:00

Dr. Patrick Walsh, former director of Johns Hopkins's Brady Urological Institute, shares his insights on choosing a doctor for your cancer surgery.

Dr. Patrick Walsh, dean of prostate cancer surgeons, has performed the technically challenging radical prostatectomy procedure thousands of times, and has personally schooled hundreds of surgeons in the finer points of the difficult nerve-sparing cancer operation. He certainly knows what it takes to be an expert in curing a man of cancer, preserving bladder function, and maintaining the nerves responsible for erections. What about the doctor you're considering for your own prostate cancer surgery?

"Your doctor may be nice and personable," says Dr. Walsh, "a practitioner whose empathy for your condition appeals to you, which is great. But what do you know about him? He's got a terrific bedside manner, but is he a board-certified urologist? What training has he had? Does he know and use the nerve-sparing cancer surgery techniques -- the anatomical approach to radical prostatectomy? How many of these cancer surgeries does he perform annually? What success has he had in preserving potency and continence? If he can't or won't give you his rate of success as compared to reports from other surgeons, or to results published in medical journals, this may be a red flag, and perhaps you should look elsewhere for your cancer surgeon.

"You should be able to get a good idea of his success rate in numbers or percentages. In addition, if he hasn't done very many of these cancer operations -- ideally, hundreds -- you might want to find a more experienced surgeon. Look at it this way: Do you want to be one of the patients he's learning on? Do you want to be part of someone's learning curve?

"Remember: You don't want a surgeon who's "pretty good" at removing the prostate. There are no second chances here: This is a one-shot operation. You are looking for the one surgeon who will perform the one radical prostatectomy you will ever receive in your life, the one operation that will cure your cancer.

"You want a surgeon who is going to make sure that no cancer is left behind, and who knows how to minimize trauma to your body during surgery so you don't wind up with incontinence, erectile dysfunction, or both.

"Finding the right surgeon may mean that you must travel to a major medical center in another city. This may mean that you'll be away from home for four days. But after that, even though you may need to wear a catheter for a week or two, the recovery from the operation is usually speedy, and follow-up communication can be carried out over the telephone."

IDing Which of the 24 Types of PCa You Have

2010-08-18T19:51:00.000-07:00

Some 218,000 American men will be diagnosed with prostate cancer this year.
An estimated 85% of those
tumors will grow so slowly that they will never cause problems. But the rest
are aggressive and lethal. As of now,
there's no way to tell early on which cancers are which, so tens of
thousands of men undergo surgery or radiation
each year for cancers that never needed treatment, risking impotence or
incontinence in the process.
Several recent genetic discoveries could help doctors evaluate how
aggressive a man's prostate cancer is much
earlier. Scientists at the University of Michigan have identified at least
24 different kinds of prostate cancer of
varying virulence whose DNA signatures can be read like a bar code. Memorial
Sloan-Kettering Cancer Center
researchers have identified other genetic subtypes of prostate cancer that
seem to predict whether the tumor will
be low or high risk. And Harvard Medical School scientists have found a
specific gene that causes prostate
cancers to spread. Some of the discoveries also could lead to new
treatments, tailored specifically for the kind of
prostate tumor a man has.

.

Transdermal Estradiol Therapy for Prostate Cancer

2010-08-17T15:15:00.000-07:00

Transdermal Estradiol Therapy for Prostate Cancer
Reverses osteoporosis of androgen suppression, reduces blood clot risk compared with oral estrogen
by Jacqueline Strax

August 11, 2005 -- Can a hormonal therapy for men with advanced prostate cancer move forward by going "back to the future"? As an alternative to standard androgen suppressing drugs like Lupron and Zoladex, some doctors and patients in the US and the UK are looking at estradiol patches.

Tomasz Beer in Oregon and Paul Abel and Jeremy Ockrim in the UK have shown that estradiol patches are effective. Because transdermal estradiol enters the bloodstream through the skin, without passing through the liver, the patches cause fewer cardiovascular side effects than oral estrogen. And compared with Lupron and Zoladex, estradiol patches seem to reduce andropause symptoms and protect against osteoporosis.

Men treated with Lupron and Zoladex experience acute onset andropause ("male menopause"). Most men experience hot flashes, and some report emotional changes and loss of libido, or sex drive.

Osteoporosis, a silent side effect, which can lead to hip or spinal fracture, is another problem with the conventional drugs, especially for white men and men who arenot overweight.

Estradiol dose can be controlled by number of patches used, placement on the body and how often patches are changed. Some men use dispenser-measured doses of estradiol gel. The gel method has not yet been tested in clinical studies, but studies have been done using estradiol patches and results look positive.

Dr. Beer at Oregon Health and Science University and Portland Veterans Affairs Medical Center tested the safety and efficacy of transdermal estradiol (TDE) and the effect on hot flashes, sex hormones, the procoagulant cascade, and bone turnover in patients with androgen independent prostate cancer (AIPC).

In the Oregon study, patients progressing after primary hormonal therapy received transdermal estradiol at a rate of 0.6 mg per 24 hours (administered as six 0.1 mg per 24-hour patches replaced every 7 days). Serum prostate-specific antigen (PSA) and hormone levels, coagulation factors, markers of bone turnover, bone density measurements, and a hot flash diary were collected at regular intervals. Median time to disease progression was 12 weeks.

Three of 24 patients (12.5%) had a confirmed PSA reduction of greater than 50 per cent. Estradiol levels in the blood increased from mean starting level of 17.2 pg.mL to 460.7 pg/mL (range, 334.6-586.7 pg/mL). Total testosterone remained suppressed to castrate levels during treatment, "but the free testosterone level decreased as a result of increased sex hormone binding globulin." Toxicity was "modest" Beer says, "and no thromboembolic complications occurred."

Jeremy Ockrim and Paul Abel At Hammersmith Hospital, London, say transdermal estradiol patches are an effective alternative to current androgen deprivation therapy. In a small pilot study men were given transdermal estradiol patches for 1 year with follow up of 15 months.

The patches produced "an effective tumor response" Abel says. Cardiovascular toxicity was substantially reduced compared with that expected of oral estrogen."The changes in the coagulation parameters suggest down regulation of the hypercoaguable state inherent to advanced prostate cancer," Abel says.

"Transdermal estradiol therapy prevented andropause symptoms" and "improved quality of life scores and increased bone density," Ockrim and Abel say. A common side effect of androgen suppression, gynecomastia (breast enlargement and soreness) was "negligible."

Estradiol levels above 1,000 pmol./l. were achieved using 2 patches and higher levels were obtained by increasing the number of patches. All patients achieved castrate levels of testosterone within 3 weeks and had biochemical evidence of disease regression. However, one patient died of disease at 14 months and 1 cardiovascular complication occurred.

The patches avoided the clotting problem (hypercoaguable state) associated with estrogen therapy (This is especially important because blood clots are associated with prostate cancer as such). Vascular flow improved. Bone mineral density was significantly increased. Mild or moderate gynecomastia occurred in 80% of patients but no patient had hot flushes. All other functional and symptomatic quality of life domains improved.

The effect on bone mineral density looks especially impressive. Ockrim measured patients for bone bone mineral density of the lumbar spine and the proximal femur with dual-energy x-ray absorptiometry, and correlated with computerized tomography and isotope bone scan findings at 6-month intervals. He found that transdermal estradiol patches improved bone mineral density of men with prostate cancer.

In 20 patients treated with transdermal estradiol patches, in all measured regions bone mineral density increased with time. By 1 year mean bone mineral density had increased by 3.60% +/- 1.6% in the lumbar spine, 2.19% +/- 1.03% in the femoral neck, 3.76% +/- 1.35% in the Ward's region and 1.90% +/- 0.85% in the total hip, respectively. Of 12 osteoporotic sites 4 had improvement based on World Health Organization grading. All other sites improved toward a better classification.

Signs of osteoporosis have been seen in some men's bone density scans within 6 months of their first shot of Lupron, although not all men develop it.

"Patients with prostate cancer treated with androgen suppression are at risk for skeletal fracture," Martin Resnick at Case Western Reserve reported in 2001, "and risk increases with the duration of therapy. Slender white men are at greatest risk. Conversely, black men and those with body mass indexes greater than normal (greater than 25 kg/m(2)) are at minimal risk despite a prolonged duration (10 years) of androgen suppression."

Bone density loss can be delayed and even reversed by biphosphonates (also called bisphosphonates and diphosphonates) , notably Zometa, a powerful drug given by rapid intravenous injection. (Less potent drugs in this class include Aredia, Actonel and Fosomax). Biphosphinates may also prevent prostate (and breast) cancer lesions from breaking down bone. Unfortunately, these drugs can cause osteonecrosis, a rare but incurable, painful condition. Some cancer patients and women with osteoporosis taking biphophonates have developed osteonecrosis (patches of dead, crumbling bone) in the jaw or elsewhere after dental extraction, trauma or fever.

Lupron was first approved by the FDA in 1985 for palliative treatment of men with advanced prostate cancer. The drug is made by Deerfield, Ill.-based TAP Pharmaceuticals Inc., which is a joint venture of Abbott Laboratories and Takeda Chemical Industries, Japan's largest drug company. The Food and Drug Administration approved Lupron and Zoladex without requiring research into their long term effects on mens' quality of life. Studies done for FDA approval purposes lasted for six weeks.

Standard treatments for advanced prostate cancer at the time were limited to surgical castration or relatively high-dose oral estrogen. The high doses of estrogen increased mens' risks of blood clots, deep vein thrombosis, pulmonary embolism and heart attacks. Lupron and Zoladex carry no increased risk of blood clot or heart attack.

In the USA Medicare covers most of the cost of Lupron, Zoladex and other drugs in that class. Younger men are not eligible for coverage, though, unless they are Veterans. Drugs like Casodex and Flutamide, which allow testosterone to circulate in the man's body while preventing it from docking in androgen receptors, are not covered by Medicare.

Cost should never be a prime motive for choosing one cancer therapy over another. But this is an undeniable factor. As Dr. Ockrim says, estradiol is available for " a tenth of current therapy cost, with the potential for considerable economic savings over conventional hormone therapies."

L

Introduction to the New ProstRcision Surgery

2010-08-15T09:14:00.000-07:00

The Highest Documented Cure Rate for Prostate Cancer

The two methods with the highest proven cure rate for prostate cancer are ProstRcision and radical prostatectomy. No other method offers the same cure rates. However, there are significant differences between these two procedures. With ProstRcision, we remove the cancer without damaging urinary muscles, so your existing level of urinary control does not change. And equally important, because nothing is cut with ProstRcision, sex nerves are spared, thus the vast majority of men maintain their sexual function.

As with any cancer, you and your family members are faced with a challenging road ahead, and no doubt, countless questions and concerns. We believe the single most important thing you can do is to perform your own personal research on prostate cancer, including knowing all your treatment options, before making a decision

Neoadjuvant Treat ent with Taxotere

2010-08-13T10:13:00.000-07:00

Neoadjuvant treatment with Taxotere® (docetaxel) and Emcyt® (estramustine) for high-risk localized prostate cancer appears to be safe and produces promising responses compared with standard treatment, according to the results of a Phase III randomized study presented at the 2010 Genitourinary Cancers Symposium in San Francisco

Prostate Cancer & Blood Clots

2010-08-13T10:10:00.000-07:00

Prostate Cancer and the Increased Risk of Blood Clots (4/23/2010)
Men with prostate cancer are at a higher risk for several types of thromboembolic diseases (blood clots), with men undergoing endocrine therapy having the highest risk, according to the results of a study published in the Lancet Oncology

Radiation Hip fractueres, and New Statins Information

2010-08-13T10:06:00.000-07:00

Men treated with external beam radiation therapy for prostate cancer may have an increased risk of hip fracture, according to data presented at the 2010 Annual Scientific Meeting of the American Urological Association.

Statin Use May Lower Risk of Prostate Cancer Recurrence (6/3/2010)
It appears that, among men who have undergone radiation therapy for early prostate cancer, use of statins may lower risk of recurrence, according to a study published in the Journal of Clinical Oncology.

Provenge's Successful Phase III Test

2010-08-13T09:38:00.000-07:00

PROVENGE® FOR HORMONE-REFRACTORY PROSTATE CANCER
CancerConsultants.com, 08/11/2010

Among men with metastatic, hormone-refractory prostate cancer, the immunotherapy agent Provenge® (sipuleucel-T) improves survival by roughly four months. The findings from this Phase III study were recently published in The New England Journal of Medicine

Duodart Treats E larged Prostate

2010-08-13T09:29:00.000-07:00

March 31, 2010
LONDON - Pharmaceutical company GlaxoSmithKline PLC said Wednesday it has received European approval for Duodart, a two-in-one drug for the treatment of the symptoms of an enlarged prostate. The drug is a combination of dutasteride, currently marketed as Avodart, and tamsulosin, a generic drug marketed by Astellas Pharma as Flomax. Glaxo received backing for the drug from Germany under the European Union's decentralized approval procedure, meaning it is applicable across the 27-member bloc. The company said national licenses are expected to be granted throughout the year

Canines May Smell Prostate Cancer

2010-08-13T09:22:00.000-07:00

Dogs May Be Able to Smell Prostate Cancer

Dogs may be able to smell the presence of prostate cancer in patient urine samples, according to data presented at the 2010 Annual Scientific Meeting of the American Urological Association (AUA).

Volatile organic compounds (VOCs) are organic chemical compounds that are derived from a number of man-made and biologic sources, including cancer cells. Data have indicated that concentrations of VOCs differ according to age and produce a scent to which animals may be particularly sensitive. Researchers have been evaluating the capability among dogs to detect cancer by scent; previous research has focused on breast, lung, and bladder cancers.

To investigate whether prostate cancer tumors may excrete certain VOCs through urine that dogs can detect by scent, researchers in Paris trained dogs to recognize the scent of VOCs from prostate cancer cells. The dogs were then trained to distinguish between urine from prostate cancer patients and urine from individuals without cancer. Following this training, the dogs were presented with five urine samples, only one of which came from a patient with confirmed cancer. The animals were instructed to identify the samples from cancer patients.

A total of 66 urine samples were used in the study; of these, the dogs correctly classified 63—meaning in 63 of the 66 samples, they accurately identified which samples were from prostate cancer patients and which were not. The dogs correctly identified 100% of urine samples from cancer patients and correctly classified 91% of samples from people without cancer.

According to the AUA Public Media Committee Chair Anthony Y. Smith, MD, “These data suggest that prostate cancer tumors may excrete certain VOCs that turn up in a patient’s urine and that this ‘scent’ may be specific to prostate cancer.” The next step will be to determine what those VOCs are and to develop a test that can identify them. Further development of accurate screening tests for prostate cancer is an important area of research, as the accuracy of the current primary screening method—the prostate-specific antigen (PSA) test—remains suboptimal.

Reference: Cornu J-N, Girardet C, Cancel-Tassin G et al. The use of canines for prostate cancer detection: towards a non-invasive alternative screening tool. Presented at the 2010 annual meeting of the American Urological Association. May 29-June 3, 2010. San Francisco, CA. Abstract 2159.

Medivation, a New Treatment for Prostate Cancer

2010-08-13T08:11:00.000-07:00

DATA FROM PHASE 1-2 TRIAL OF MDV3100 IN ADVANCED...
NewsRx.com,

April 22, 2010
Medivation, Inc. (NASDAQ:MDVN) and Astellas Pharma Inc. announced publication of positive results from their previously reported Phase 1-2 trial of the novel triple-acting oral androgen receptor antagonist MDV3100 in men with progressive, metastatic castration-resistant prostate cancer in the April 15 online version of The Lancet. According to the published results, MDV3100 demonstrated anti-tumor activity in patients with late-stage prostate cancer as evaluated by reductions in prostate specific antigen (PSA) levels, radiographic findings and circulating tumor cell (CTC) counts. Anti-tumor effects were observed in patients who were resistant to standard anti- androgen treatments, as well as in patients who had progressed following chemotherapy. MDV3100 is currently in Phase 3 development for the treatment of advanced prostate cancer (see also Medivation, Inc.; Astellas Pharma Inc.). "MDV3100, with its unique mechanism of action, could offer an important new treatment option to men with prostate cancer that is resistant to currently available anti-androgens," said Howard Scher, M.D., lead author of The Lancet article and chief of the Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center in New York. "It is particularly encouraging that antitumor activity was seen on all outcomes assessed in patients who had failed chemotherapy because their survival times are one year or less, on average, and their treatment options are limited."

ASTRO PRESIDENT SPEAKS ON PROSTATE CANCER

FDA Criticizes Dendreon's Claims for Provenge

2010-08-10T19:07:00.000-07:00

ERSSTOREABOUT US

FDA Objects to Dendreon Promotions for Provenge
Reuters | 08.06.2010
Dendreon Corp. exaggerated the benefits of its novel prostate cancer vaccine and downplayed risks in some sales materials for the product, U.S. regulators said in a letter released on Friday.

"These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of Provenge," the U.S. Food and Drug Administration said in a letter to the company.

Some of Dendreon's promotions included a chart that "does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of" the company's main study, the FDA said.

The materials also left out some information about sterility testing, the agency said.

The FDA asked Dendreon to immediately stop using the promotions and any others with similar claims.

Dendreon spokeswoman Katherine Stueland said the company "has spoken with the FDA and intends to comply with the request."

The FDA approved Provenge in April for treating advanced prostate cancer.

Unlike traditional vaccines that prevent a disease, Provenge treats prostate cancer by stimulating the body's own immune system to attack malignant cells. It is produced by taking cells from a patient's tumor and incorporating them into a vaccine that is injected back into the patient.

Dendreon shares fell slightly after the FDA letter was released, but recovered to close 1.5 percent higher at $39.05 on Nasdaq.

The FDA posted the letter here:

PROVENGE (sipuleucel-T) - Untitled Letter
DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448

August 3, 2010

Helen Kim
Director of Regulatory Affairs
Dendreon Corporation
3005 First Avenue
Seattle, WA 98121

Re: PROVENGE® (sipuleucel-T)
BLA STN# 125197

Dear Ms. Kim:

The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) has reviewed an In Service Kit (P-A-04.10-007.00) (kit) and PROVENGE Detail Aid (P-A-04.10.009.00) (detail aid) for PROVENGE® (sipuleucel-T). Dendreon Corporation (Dendreon) submitted the kit and detail aid under cover of Form FDA 2253 on May 4 and May 27, 2010, respectively.

These promotional materials are false or misleading because they omit and minimize the risks and overstate the efficacy of PROVENGE. Therefore, this material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).

Background

According to the FDA-approved prescribing information (PI), PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

The Warnings and Precautions section of the PI includes, but is not limited to, the following risks for PROVENGE:

PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination.

According to the Clinical Studies section of the PI, the effectiveness of PROVENGE was studied in 512 patients, “randomized in a 2:1 ratio to receive PROVENGE (n=341) or control (n=171).” This study “was a randomized, double-blind, placebo-controlled, multicenter trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.” As shown in Table 2, the observed median survival time for patients randomized to the PROVENGE arm was 25.8 months and for patients randomized to placebo was 21.7 months. The Hazard Ratio was 0.775 (95% Confidence Interval: 0.614, 0.979). The study achieved a p-value of 0.032 based on a log-rank test (not pre-specified).

Omission and Minimization of Risk Information

Promotional materials are misleading if they fail to reveal facts that are material in light of representations made with respect to consequences that may result from the use of the product as recommended or suggested by the materials.

Specifically, the kit presents a misleading product timeline on the slide entitled, “Is PROVENGE therapy approved for infusion?” The timeline includes “Test Results Complete” before the product arrives at the office, which is contrary to the Warnings and Precautions section of the PI which states that the final (7-day incubation) sterility test results are not available at the time of infusion. Furthermore, the kit omits the Warning and Precaution that the final sterility test results are not available at the time of infusion.

Overstatement of Efficacy

Promotional materials are misleading if they contain a representation or suggestion, not approved or permitted for use in the labeling, that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience.

Page seven of the professional detail aid includes a chart entitled, “Kaplan-Meier Survival Rate Estimates.” This chart presents the percentage of patients alive at 12, 24, 36 and 48 months. This information is misleading because it does not provide sufficient contextual information for the presented survival rate estimates to convey the limitations of the study. For example, the chart does not include a measure of variability, such as the 95% confidence intervals, when presenting the survival rate estimates.

Conclusion and Requested Actions

For the reasons discussed above, your promotional material misbrands PROVENGE under sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §352(a) and §321(n), and FDA implementing regulations, Cf. 21 CFR 202.1(e)(5)(iii) and (e)(6)(i).

We request that Dendreon immediately cease the dissemination of these violative promotional materials for PROVENGE, as well as promotional materials with the same or similar representations. Please submit a written response within ten (10) business days of the date of this letter, stating whether you intend to comply with this request, listing all violative promotional materials for PROVENGE and explaining your plan for discontinuing use of such materials. Please direct your response to Lisa Stockbridge, PhD, Acting Branch Chief at the Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Compliance and Biologics Quality, Division of Case Management, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. In all future correspondence regarding this matter, please refer to the BLA/STN number. We remind you that only written communications are considered official responses.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for PROVENGE comply with each applicable requirement of the Act and FDA implementing regulations.

If you choose to revise your promotional materials, APLB is willing to assist you in assuring that your revised materials comply with applicable provisions of the Act by reviewing your revisions before you use them in promotion.

Sincerely,

Robert A. Sausville
Director, Division of Case Management
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

Statins &Painkillers May Skew PCaScreening Results

2010-08-10T18:59:00.000-07:00

Statins, Painkillers May Upset PSA Test Results
Common medications might affect prostate cancer diagnoses, researchers say
by Amanda Gardner | HealthDay | 08.06.2010
Some of the most widely prescribed drugs in the United States may skew results of prostate cancer screening tests, possibly causing errors in diagnoses, a new study finds.

A prostate cancer diagnosis is typically based on an elevated PSA (prostate-specific antigen) level, but new research shows that common drugs, including cholesterol-lowering statins and certain painkillers, may lower PSA levels.

"Our study reveals that men regularly consuming NSAIDs [non-steroidal anti-inflammatory drugs], statins, and thiazide diuretics may have lower serum PSA levels compared to men who are not taking these medications," said Dr. Steven L. Chang, lead author of a paper published online Aug. 2 in the Journal of Clinical Oncology.

"This could be a confounder when you're trying to screen for prostate cancer," added Dr. Lionel L. Bañez, assistant professor of urologic surgery at Duke University Medical Center in Durham, N.C. "We should exercise caution in interpreting PSA results from patients who are taking any of these medications, especially those who are taking these medications for a long time."

But for now, men shouldn't worry unduly that their health is being compromised, said another expert.

"One PSA reading does not give accurate information," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La. "You want to follow the trend over a number of years. It's time that makes a difference."

Other studies have suggested that these drugs as well as others used to treat enlarged prostate can lower PSA levels, but those studies suffered from various limitations, the authors reported.

Chang and his colleagues studied the effect of 10 common medications on PSA test readings in 1,864 men age 40 and older with no history of prostate cancer.

One year of using NSAIDs, statins or thiazide diuretics gave PSA readings 1 percent, 3 percent and 6 percent lower, respectively, than those for men not on one of these drugs.

The numbers were significantly higher after five years: 6 percent, 13 percent and 26 percent lower PSA levels, respectively.

When statins were combined with the diuretics over five years, PSA levels were lowered 36 percent, the researchers found. (But taking calcium channel blockers -- often prescribed for high blood pressure -- neutralized that effect.)

It's not known why these three classes of medications have this effect, but the finding merits further study, the researchers said.

"The reason why these medications are associated with a lower PSA are unclear, and therefore it is impossible at this time to determine the true implications of our findings," said Chang, who conducted the study while at the Stanford University School of Medicine but is now affiliated with Brigham and Women's Hospital and Harvard Medical School in Boston.

Given how many older men take one or more medications, and often take NSAIDs, statins, or thiazide diuretics, the findings could affect a vast number of people, the authors stated. (The American Urological Association recommends offering prostate cancer screening to men starting at age 40.)

"If future studies show that the difference in PSA has no bearing on the development of prostate cancer, then it may be necessary to lower the PSA threshold for recommending prostate needle biopsies in men who are taking NSAIDs, statins and thiazide diuretics," Chang said.

Another possibility is that these drugs may actually have a protective effect against cancer, researchers speculated.

"Should studies demonstrate that these medications reduce the risk of developing prostate cancer, then there may be some role for NSAIDs, statins and thiazide diuretics in prostate cancer prevention," said Chang.

NSAIDs and statins are already being studied as a means of preventing prostate cancer or its progression, Bañez said.

"There may be another story here," he said.

Nat'l Comprehense Cancer Network Intoduces Proventys

2010-08-07T19:06:00.000-07:00

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News and Updates from the National Comprehensive Cancer Network® (NCCN®) July 26, 2010 | Volume 2 • Issue 15

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NCCN and Proventys to Launch Novel Decision Support System
NCCN has entered into an exclusive collaboration with Proventys, a leader in advanced decision support technologies, to introduce the Proventys CDS Oncology™ system, a first-of-its-kind Web platform designed to arm oncologists with the information and evidence necessary to deliver high-quality patient care. Through this novel, point-of-care platform, Proventys and NCCN are integrating the standard in oncology practice guidelines with technologies that enable clinicians to assess individual patient factors and make decisions along cancer treatment paths more effectively.

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Dr. Schellhammer' Argument for Provenge InsCoverage

2010-07-29T19:56:00.000-07:00

Commenter: Schellhammer, Paul
Title: professor of urology
Organization: urology of virginia/eastern virginia medical school
Date: 07/26/2010
Comment:
I have had experience with delivery of ACI
(Provenge) over the past 10 years in their
multiple trials. I am very favorably impressed
by the clinical trial survival benefit and the
lack of toxicity. I am interested in offering
this to patients with far-advanced prostate
cancer. Please make it possible for me to do so
at the completion of review, and in the interim,
please provide a directive for current coverage.
Men who have to wait one year for a review may
indeed die or become too ill before this
treatment is available. The majority of the men
who participated in clinical trials with active
cellular immunotherapy were over the age of 65,
were found to benefit significantly from therapy,
and should not be denied the opportunity for this
therapy now and over the next year due to
reimbursement issues

The treatment is reasonable because it is not
associated with significant toxicity ( Much less
than chemotherapy (docetaxel) and it is necessary
because it provides better survival outcomes than
chemotherapy (docetaxel). Currently docetaxel is
FDA approved and reimbursed for this group of
patients. ACI is safer and more effective and
likely will be proven to be more cost-effective
as well absent the management of toxicities.

Paul Schellhammer MD

2010-07-29T19:09:00.000-07:00

From: J Manarite
Subject: Re: [Prostatecanceraction] Trailblazers (Medicare) & Provenge
To: "ProstateCancer Action"
Date: Thursday, July 29, 2010, 12:01 PM

I've been trying to do my homework on this, so here's what I know about Trailblazers - Correct me if I'm Wrong -
First of all, remember there are 2 separate Medicare/Provenge issues happening right now. One is the CMS (national Medicare) which the Public Comment is part of. This process is called an NCA or an NCD, and onces it is started, will take close to a year to be complete. This is not the Traiblazer issue.

- - - - - - - - - -
So, here's the Trailblazers issue. While CMS is conducting their NCA, the local/state Medicare Carriers (MAC's) can pay for Provenge. It looks like this:

10 different MAC's, (only 3 have written policies covering Provenge - 7 do not. Traiblazers is one of the 7.)
15 different jurisdictions covering (only 5 have written policies covering Provenge - 10 do not.)
50 states + D.C. + 5 US territories (only 12 states + 2 US territories have written policies covering Provenge)
plus a little bit of arm wrestling in the court system over which MAC has which jurisdiction

So, here is what Traiblazers' jurisdiction currently looks like (to the best of my knowledge)

* Jurisdiction 4 (J4)- Trailblazers Health Enterprises - Colorado, New Mexico, Oklahoma, Texas

* Jurisdiction 11 (J11) - North Carolina, Virginia - Currently Trailblazers Health Enterprises, but Awarded to Palmetto GBA? - (dependent on expected Sept court ruling)

I think the take-home message is that advocates in CO, NM, OK, TX, NC, SC, VA, and WV might get together and start communications with Trailblazers.

correction (from Scott Riccio@ Dendreon) - SC and WV are NOT Trailbalzers for Medicare part B. They are Palmetto, so they are getting Provenge paid for. Good news.

At this point, we are not only advocating for the patients, we are advocating for and with the physicians. Think about the key physicians in the Trailblazer states that have their hands tied re: Provenge reimbursement. Here's one - E David Crawford posted today on Public Comment. Plus - Provenge PI's - Dr Logothetis, Dr Schellhammer - somebody add names, because I know there's more.

I am working on Florida.
Jan Manarite
PCRI Florida Educational Facilitator
(239) 395-0995

--------------------------------------------------------------------------------
From: kmeadelist@aec225.com
To: prostatecanceraction@malecare.com
Date: Wed, 28 Jul 2010 23:12:49 -0400
Subject: Re: [Prostatecanceraction] Medicare & Provenge - an update or 2

I was just told by the wife of a patient in New Mexico that Trailblazer has said they will not pay for Provenge and they were told by the doctor today that he can’t get Medicare/Trailblazer to pay for Jevtana for prostate cancer. She is very upset because these were his last treatment options.

Kathy

From: prostatecanceraction-bounces@malecare.com [mailto:prostatecanceraction-bounces@malecare.com] On Behalf Of J Manarite
Sent: Thursday, July 22, 2010 6:40 PM
To: ProstateCancer Action
Subject: [Prostatecanceraction] Medicare & Provenge - an update or 2

First of all, the CMS public comment (part of a national process that will take almost a year) is a separate issue than the individual Medicare Carrier decisions (which can happen now). So, here's what I've learned.

- - - - - - - -
*Current Status -
Individual Medicare Carriers & their states (Jurisdictions)
Provenge Policy IN WRITING? (when)

Jurisdiction 1 (J1) Palmetto GBA- American Samoa, California, Guam, Hawaii, Nevada, Northern Mariana Islands - YES (May '10)Jurisdiction 2 (J2)- Alaska, Idaho, Oregon, Washington - Awarded to National Heritage Insurance Company - ? (Jim Kiefert may know more)
Jurisdiction 3 (J3)- Noridian Administrative Services -Arizona, Montana, North Dakota, South Dakota, Utah, Wyoming - NO
Jurisdiction 4 (J4)- Trailblazers Health Enterprises - Colorado, New Mexico, Oklahoma, Texas - NO
Jurisdiction 5 (J5)-Wisconsin Physician Services Health Insurance Corporation- Iowa, Kansas, Missouri, Nebraska - NO
Jurisdiction 6 (J6) - Illinois, Minnesota, Wisconsin- Awarded to Noridian Administrative Services * -NO
Jurisdiction 7 (J7) - Arkansas, Louisiana, Mississippi - Awarded to Pinnacle Business Solutions Inc.* -NO
Jurisdiction 8 (J8) - Indiana, Michigan - Awarded to National Government Servces * - NO
Jurisdiction 9 (J9)-First Coast Service Options-Florida, Puerto Rico, United States Virgin Islands - NO
Jurisdiction 10 (J10) -Cahaba Government Services -Alabama, Georgia, Tennessee - NO
Jurisdiction 11 (J11)-North Carolina, South Carolina, Virginia, West Virginia - Awarded to Palmetto GBA? - not yet, but YES (dependent on expected Sept court ruling)
Jurisdiction 12 (J12)-Highmark Medicare Services -Delaware, District of Columbia, Maryland, New Jersey, Pennsylvania -NO
Jurisdiction 13 (J13)-National Government Services -Connecticut, New York - YES (July '10)
LINK: http://www.ngsmedicare.com/sia/ARTICLE%20%20Sipuleucel_T_ProvengeRelatedtoLCDL25820_A50060.htm
Jurisdiction 14 (J14) - National Heritage Insurance Company - Maine, Massachusetts, New Hampshire - NO
Jurisdiction 15 (J15) -Kentucky, Ohio- Awarded to Highmark Medicare Services * - NO

Calcium & Vit E Supplements Don't Cause Disease

2010-07-08T10:05:00.000-07:00

Daily Health News: Calcium, Vitamin D Supplements OK for Arteries
No evidence of raised stroke or heart risks in those taking moderate doses, researchers say
--------------------------------------------------------------------------------
7/5/2010
(HealthDay News) -- Moderate doses of calcium and vitamin D supplements don't raise women's coronary artery calcium (CAC) levels, a new study finds.

Deposits of calcium in blood vessels have been linked to blood vessel blockages and increased risk of heart attack and stroke. Because of this, many women have concerns about taking calcium pills to maintain bone strength, according to the authors of a report published in the June 16 issue of the journal Menopause.

For this study, the researchers used cardiac computed tomography imaging to measure CAC levels in 754 women who were aged 50 to 59 at the time of enrollment. CAC scores were similar among women who took calcium (1,000 milligrams of elemental calcium daily) plus vitamin D3 (400 International Units daily) for an average of seven years and women who took a placebo.

"This study provides reassuring evidence that moderate doses of calcium and vitamin D supplements do not increase calcium deposition in the coronary arteries. Thus, women need not avoid these supplements and sacrifice bone health due to concern about such a risk," Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston, said in a hospital news release.

More information

The U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases has more about calcium and vitamin D.

SOURCE: Brigham and Women's Hospital, news release, June 15, 2010
Copyright © 2010 HealthDay. All rights reserved.
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You should also consult with a healthcare professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem.

Medicare Review of Provenge

2010-07-07T14:47:00.000-07:00

ABOUT PROSTATE CANCERGET INVOLVEDPROGRAMSRESEARCHPARTNERSSTOREABOUT US

Risk Factors

Prevention

Detection

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New Prostate Cancer Research

Prostate Cancer Resources

Dendreon: Medicare Reviewing Provenge Coverage
by Marley Seaman | The Associated Press | 07.02.2010
Medicare administrators say they will take a full year to review Dendreon Corp.'s prostate cancer therapy Provenge and decide whether to cover the costly treatment.

Provenge, which costs $93,000 for a course of treatment, has been widely expected to bring Dendreon billions in revenue in the coming years. But sales will be slashed if Medicare decides not to cover the cost or offers only limited coverage. Medicare's Coverage and Analysis Group will propose a decision in about nine months and make a final ruling about a year from now. That decision will apply to all Medicare contractors.

Shares of Seattle-based Dendreon fell $2.20, or 6.8 percent, to close at $30.13. The stock fell as much as 13.4 percent earlier in the session.

The Food and Drug Administration approved Provenge in late April for patients who have prostate cancer that has spread and that has not responded to hormone-based treatment. Some Medicare insurance contractors already are paying for the therapy, but there is no national policy. Contractors can continue to cover Provenge during the agency's review, but must adhere to any final decision.

Medicare is evaluating whether or not it is reasonable and necessary to cover Provenge. Company studies have shown that taking Provenge added four months to the lives of men with advanced prostate cancer, about a month-and-a-half longer than that afforded by Sanofi-Aventis SA's Taxotere, the only chemotherapy approved for men in this situation. Doctors hope for even greater benefit if they give the drug earlier in the course of the disease.

The Coverage and Analysis Group is a team of medical officers, managers and analysts. A technical panel and a coverage advisory committee also will take part in the review. The group will be considering whether it makes sense to cover a costly drug that has a relatively narrow approval. But if it decides to cover Provenge treatment for patients with less advanced cancer, that could help sales.

Medicare will also deal with a deceptively simple question: what is Provenge? Is it a traditional drug, a biologic drug, or something else? The answer could affect the amount that Medicare will cover because different types of drugs are covered at different rates.

Provenge is designed to train a patient's immune system to attack tumors. It is different from traditional drugs and even biotech drugs because it is made by mixing blood cells from the individual patient with a protein found on cancer cells and an immune system-boosting substance.

Side effects of Provenge are relatively mild, such as chills, fatigue, fever, and headache. By comparison, side effects of chemotherapy typically include hair loss, nausea, anemia and diarrhea.

About 192,000 new cases of prostate cancer were diagnosed in 2009, and 27,000 men died of the disease, according to the FDA. Prostate cancer most often affects older men.

Wednesday [June 30] marked the beginning of a 30-day public comment period on coverage. After the comment period ends, the agency will take about nine months to create a proposal. The public will then have 30 days to comment on the proposal, and Medicare will publish a final decision within 60 days of the end of that comment period. The decision goes into effect as soon as it is published.

Swedish Study:PSA Test Saves Lives

2010-07-07T14:24:00.000-07:00

Sanofi's New Drug Jevtana has FDA Approval

2010-06-30T13:07:00.000-07:00

Advanced Prostate Cancer, Sanofi Could See Expansion to First-Line Use
The Pink Sheet Daily. 2010 Jun 21, E Hayes

Sanofi-Aventis gained a fast approval for its chemotherapy Jevtana (cabazitaxel) - just 11 weeks after the final filing in a rolling submission for second-line treatment of advanced hormone-refractory prostate cancer. But the company is also positioned for a quick expansion to the first-line setting.

Cabazitaxel, the successor to the company's soon-to-lose exclusivity Taxotere , was cleared on June 17 for use in combination with the steroid prednisone to treat men with prostate cancer after treatment with Taxotere (docetaxel).

As part of its post-marketing commitments, Sanofi is required to conduct another Phase III study in second-line treatment and a Phase III study in the first-line setting.

However, Jevtana's potential in earlier-stage disease could be limited by its toxicity profile, Leerink Swann analyst Seamus Fernandez noted. Cabazitaxel is linked to severe, potentially fatal side effects that are given a very high profile in FDA labeling, including a boxed warning for neutropenia and severe hypersensitivity.

The side effect profile could be a determining factor, especially given the availability of Dendreon's just approved first-line treatment Provenge , as well as less toxic agents in late-stage development, particularly Cougar/Johnson & Johnson's abiraterone, Fernandez added. On the other hand, Provenge's penetration is likely to be limited by supply constraints, the analyst noted.

Sanofi said it is confident in Jevtana's potential, and has trials getting under way in lung, ovarian and breast cancer.

Taxotere is Sanofi's fourth best-selling product with sales of €2.1 billion ($2.5 billion) in 2009. But the product faces patent expiry at the end of 2010. While sales breakdowns are not available, Taxotere's success clearly has been driven by its application in multiple indications. In addition to prostate cancer, the drug is approved in non-small cell lung cancer, breast cancer, gastric cancer and head and neck cancer.

Targeting Area Of High Unmet Need

Approval of Jevtana was supported by the open-label Phase III TROPIC study of 755 patients, in which Jevtana was shown to improve survival in a very tough-to-treat population. Median overall survival for patients receiving Jevtana plus prednisone was 15.1 months compared with 12.7 months for patients receiving the chemotherapy drug mitoxantrone.

Jevtana marks an important achievement for an area in need of clinical advances. Metastatic prostate cancer ultimately becomes resistant to hormone treatment, and no drugs had been cleared for those who progress on Taxotere. Results were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in March and were considered game-changing.

Room To Maneuver On Pricing

After the glowing reception of the TROPIC results at the ASCO symposium, Leerink doubled its pricing assumption for Jevtana to $5,000 per cycle, with each patient receiving four cycles. Taxotere has a "surprisingly low" price of about $3,000 per cycle, with patients typically receiving six cycles, Fernandez noted.

Leerink estimates that of the 2 million men with prostate cancer in the U.S., about 17,000 could be eligible to take Jevtana. Assuming a $5,000 price, Leerink conservatively projected in a March 9 note Jevtana sales of €270 million ($333 million) in 2016. This estimate is for the second-line prostate cancer indication alone.

Fernandez also noted that Sanofi has a "wide berth to operate in, given pricing that we have seen with Provenge." Provenge came with a whopping sticker price of $93,000 per year, surpassing analyst expectations.

In an interview, Paul Chew, Sanofi's chief science officer and chief medical officer for the U.S., declined to comment on the price, beyond saying it would reflect the 14 years of development time and the value the product brings to patients.

Dendreon had argued that the price was on par with other oncology treatments when the four months of survival made possible by the vaccine were taken into account. If Sanofi applied the same logic, 2.4 months of benefit could equate to a $50,000-plus price, Fernandez observed.

Label Includes Extensive Safety Warnings

While extensive side effects are to be expected with cytotoxic drugs, Jevtana's labeling indicates a high range of potentially fatal outcomes and significant requirements for management that could present a barrier to wider use.

There is potential for severe hypersensitivity, including generalized rash/erythema, hypotension and bronchospasm - as detailed in a boxed warning. Consequently, every time cabazitaxel is administered patients must be premedicated 30 minutes prior to treatment with a corticosteroid, an antihistamine and an H2 agonist. Antiemetic prophylaxis also is advised, and labeling calls for monitoring of complete blood counts on a weekly basis; Jevtana should not be administered to patients with low neutrophil counts.

Many of the side effects associated with Jevtana are familiar with chemotherapy, but labeling spells out the degree of severity (including deaths) of neutropenia and diarrhea.

"Five patients experienced fatal infectious adverse events (sepsis or septic shock)," labeling states. The label advises G-CSF may be administered to reduce the risks of neutropenia complications, recommending prophylactic use in high-risk patients.

In a clinical trial, deaths related to diarrhea and electrolyte imbalance also occurred, and labeling states "intensive measures may be required." Renal failure is another risk that can have a fatal outcome.

Safety data were collected from a randomized controlled trial comparing Jevtana with prednisone to mitoxantrone and prednisone in 371 patients with hormone-refractory metastatic prostate cancer. Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5 percent) Jevtana-treated patients compared to 3 (<1 percent) of mitoxantrone-treated patients. The most common fatal adverse reactions in Jevtana-treated patients were infections (5 patients) and renal failure (4 patients). The majority (4 of 5 patients) of fatal infection-related adverse reactions occurred after a single dose of Jevtana.

Patients older than 65 were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Older patients need to be monitored closely, the label advises.

Though the risks associated with cabazitaxel are heavy, they are countered by the significance of the efficacy findings: a survival advantage in a population without treatment options.

Approved With Gleevec-like Speed

FDA approval came well before the Sept. 30, 2010, user fee goal date, and the press statement on the approval included a big endorsement from Richard Pazdur, director of the Office of Oncology Drug Products.

"Patients have few therapeutic options in this disease setting. ... FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer," the statement said.

Sanofi's Chew stressed the value his company places on showing a survival benefit for oncology drugs: "The Holy Grail in drug development is increased survival over standard of care. I believe FDA saw this as a significant advance, the first and only drug to provide significant benefit in second-line treatment of hormone resistant prostate cancer."

The swift approval is certainly outstanding - though it has a few precedents in the oncology sphere, such as Novartis' Gleevec , approved in nine weeks.

FDA noted that Sanofi's own Eloxatin (oxaliplatin) for second-line colorectal cancer was approved in only six weeks (6 'The Pink Sheet,' Aug. 13, 2002). Other examples of oncology drugs that had extremely fast reviews include Millennium's Velcade (bortezomib) and Genenetch's Herceptin (trasztuzumab).

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New 2008 Study Strengthens Agent Orange PCa Assn

2010-06-30T06:41:00.000-07:00

http://www.sciencedaily.com/releases/2008/05/080515072810.htm

New Study Strengthens Association Of Prostate Cancer With Exposure To Agent Orange
ScienceDaily (May 16, 2008) — As men age, their risk of developing prostate cancer increases. Aging Vietnam veterans are giving researchers new opportunities to solidify the connection between in-country exposure to Agent Orange and subsequent prostate cancer development. In a study presented during the Annual Scientific Meeting of the American Urological Association (AUA) in Orlando, researchers presented data from a large study of veterans enrolled in the Northern California VA System, examining prostate cancer incidence and disease characteristics in those exposed to Agent Orange compared to those who were not exposed.

More than 13,000 Vietnam Veterans were divided into two groups based on their exposure to Agent Orange. Twice as many men exposed to Agent Orange were identified with prostate cancer. Agent Orange-exposed men were also diagnosed younger and were more likely to present with aggressive or metastatic disease. Other prostate cancer risk factors – race, body-mass index (BMI) and smoking – were not statistically different between the two groups.
This increased evidence suggests that exposure to Agent Orange should be considered a risk factor for developing prostate cancer, similar to African-American heritage or a family history of the disease.
About Agent Orange
Agent Orange is a combination of two synthetic compounds known to be contaminated with the dioxin tetrachlorodibenzo-para-dioxin (TCDD) during the manufacturing process. Named for the color of the barrel in which it was stored, Agent Orange was one of many broad-leaf defoliants used in Vietnam to destroy enemy ground cover. It is estimated that more than 20 million gallons of the chemicals, also known as “rainbow herbicides,” were used between 1962 and 1971; approximately half of the herbicides were Agent Orange. In 1997, the International Agency for Research on Cancer re-classified TCDD as a Group 1 carcinogen, a classification that includes arsenic, asbestos and gamma radiation.
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Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by American Urological Association.

Journal Reference:
0. Chamie K, deVere White RW, Ellison LM: Agent Orange exposure, Vietnam War veterans and the risk of prostate cancer. J Urol, suppl., 2008; 179: 149, abstract 421. [link]

Need to cite this story in your essay, paper, or report? Use one of the following formats:
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MLA
American Urological Association (2008, May 16). New Study Strengthens Association Of Prostate Cancer With Exposure To Agent Orange. ScienceDaily. Retrieved June 29, 2010, from http://www.sciencedaily.com /releases/2008/05/080515072810.htm

Note: If no author is given, the source is cited instead.

http://www.sciencedaily.com/releases/2007/05/070520091858.htm

Veterans Exposed To Agent Orange Have Higher Rates Of Prostate Cancer Recurrence
ScienceDaily (May 21, 2007) — Veterans exposed to Agent Orange have a 48 percent increased risk of prostate cancer recurrence following surgery than their unexposed peers, and when the disease comes back, it seems more aggressive, researchers say.

"We need to be screening these patients earlier, treating their cancer aggressively and following them closely afterward because they are at higher risk for recurrence," says Dr. Martha Terris, chief of the Urology Department at the Augusta Veterans Affairs Medical Center and professor of urology at the Medical College of Georgia.
"We looked at all patients, whether they were exposed or not, to see which were more likely to develop a recurrence and patients with a history of Agent Orange exposure were more likely," says Dr. Sagar R. Shah, MCG urology resident who is presenting the data May 20 during the American Urological Association Annual Meeting in Anaheim, Calif.
The study looked at 1,653 veterans who had prostate cancer surgery at Department of Veterans Affairs Medical Centers in five cities between 1990 and 2006; 199 had been exposed to Agent Orange, a herbicide and defoliant sprayed on the dense forests of Vietnam during the war.
Agent Orange contains the carcinogen, dioxin, which can be stored in body fat and is believed to make its way into the cell nucleus and work as a tumor promoter. In the past, relatively higher mortality rates have been found in chemical plant workers and farmers with prostate cancer who were exposed to dioxin, the researchers write in their abstract.
Dioxin's impact is dose-related, and while the researchers did not measure levels of dioxin or Agent Orange, they suspect that blacks, who were more likely to be ground troops, also were more likely to have had more Agent Orange exposure.
Researchers found veterans with Agent Orange exposure more likely to be black and younger at the time of surgery to remove their prostate gland. The disease appeared to be caught earlier in exposed veterans. Most had their disease staged as T1 by pathologists, which means it appeared confined to the prostate gland, and had lower pre-operative prostate specific antigen scores, an indicator of disease aggressiveness.
However, when the disease recurred, exposed veterans experienced a more rapid biochemical progression of their disease, which PSA measures. In blacks, the PSA doubled in almost half the time of their unexposed peers.
A blood PSA level screens for prostate cancer for most men beginning at age 50 and at age 40 for blacks and men with a family history. Black men have been shown by Dr. Terris and others to have more aggressive disease earlier in life.
To account for known racial differences, researchers also compared recurrence rates in exposed and non-exposed blacks and whites and the results held up. "As a population in general, if you were exposed to Agent Orange, you're more likely to have a recurrence," says Dr. Shah. "If you were black and exposed, you were more likely to recur than if you were black and unexposed."
If it sounds odd that men who had their prostate removed could have disease recurrence, Dr. Terris points out that microscopic cancer cells can migrate out of the area before surgery, becoming detectable later when they start pushing PSA levels back up.
In fact, following any type of prostate cancer treatment, men routinely get PSA levels checked for the rest of their lives. Without cancer recurrence, they should stay at zero.
The study was funded by the Georgia Cancer Coalition and the Department of Veterans Affairs.
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Story Source:
The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Medical College of Georgia.

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MLA
Medical College of Georgia (2007, May 21). Veterans Exposed To Agent Orange Have Higher Rates Of Prostate Cancer Recurrence. ScienceDaily. Retrieved June 29, 2010, from http://www.sciencedaily.com /releases/2007/05/070520091858.htm

Note

WSJ Article,At Least 24 Different Forms of PCa

2010-06-29T19:00:00.000-07:00

Scientists may soon be able to answer the agonizing question facing men with prostate cancer: Does their cancer
need immediate treatment or can it be left alone?
Some 218,000 American men will be diagnosed with prostate cancer this year. An estimated 85% of those
tumors will grow so slowly that they will never cause problems. But the rest are aggressive and lethal. As of now,
there's no way to tell early on which cancers are which, so tens of thousands of men undergo surgery or radiation
each year for cancers that never needed treatment, risking impotence or incontinence in the process.
Several recent genetic discoveries could help doctors evaluate how aggressive a man's prostate cancer is much
earlier. Scientists at the University of Michigan have identified at least 24 different kinds of prostate cancer of
varying virulence whose DNA signatures can be read like a bar code. Memorial Sloan-Kettering Cancer Center
researchers have identified other genetic subtypes of prostate cancer that seem to predict whether the tumor will
be low or high risk. And Harvard Medical School scientists have found a specific gene that causes prostate
cancers to spread. Some of the discoveries also could lead to new treatments, tailored specifically for the kind of
prostate tumor a man has.
Such genetic tests for prostate cancers would go well beyond the current PSA test (for prostate-specific antigen)
used for screening men in general. PSA tests have helped find prostate cancers at much earlier stages, saving
thousands of lives in recent years. But PSA levels also rise for reasons that have nothing to do with cancer,
prompting many men to have prostate biopsies each year that don't find cancer or that find tumors of the
slow-growing variety.
Scientists say new prostate-cancer tests could be available in the
not-too-distant future. "It won't be tomorrow, but if you go by
the pace at which such technology entered the field of breast
cancer, it will be several years [for new prostate tests], not a
decade," says Charles Sawyers, chairman of human oncology and pathogenesis at Memorial Sloan-Kettering.
At the University of Michigan, researchers have focused mainly on what are known as gene fusions, in which
DNA from some genes gets stuck to other genes, altering what they do. Two of the 24 types they have identified
involve the same gene, known as RAF, that drives malignant melanoma, according to a report in the journal
Nature Medicine this month. Although those two types make up only about 2% of the tumors studied so far, they
are highly aggressive, killing an estimated 3,600 men each year.
Treatment for those prostate cancers is on the horizon. Several anti-RAF drugs to treat melanoma have
regulatory approval or are in late-stage clinical trials. Early lab tests show that some of those drugs are effective
What the Genes Tell
Researchers are closing in on ways to determine
whether a prostate tumor is likely to metastasize,
based on gene analyses. Click to enlarge image.
against RAF prostate-cancer cells.
Most of the remaining prostate-cancer types involve fusions of a
gene called ETS, and they are more or less virulent depending
on which fragments of other genes are fused to them. Jonathan
Simons, chief executive officer of the Prostate Cancer
Foundation, which funds much of the Michigan research, likens
the process to rebuilding car engines out of random automotive
parts.
"If you have a tumor with a lawn-mower engine, it may look like
a cancer, we may call it a cancer, but it may never be a problem
in the life of a 72-year old man," he says. "But if you have a
cancer with a bulky Dodge Hemi stuck to a BMW 850csi V-12
engine, that needs treatment."
Four of the 24 cancer types discovered, which together make up
over 50% of the prostate cancers classified so far, have the
equivalent of lawn-mower engines and probably don't have enough power to grow past the prostate gland, Dr.
Simons says. Another 20% are more highly powered and could pose problems in the presence of other gene
fusions.
Getting Aggressive
And one of the most aggressive types, representing 10% to 15% of prostate cancers, appears to follow a different
mechanism: It results when there are excess amounts of a protein known as SPINK1. Since the protein shows up
in urine, the researchers say a urine test could be designed to measure its presence.
There could be more types, represented by different genetic bar codes. "We are finding more every month or so,
filling in the gaps," says the lead investigator Arul Chinnaiyan, director of the Michigan Center for Translational
Pathology. To validate the findings, researchers, who so far have studied some 300 tumor samples, plan to
analyze at least 1,000 samples and to follow how the patients progress.
"We are not there yet, but within the next year, we hope to have a clinical lab test where we can predict what kind
of cancer a man has," says Dr. Chinnaiyan.
Researchers at Memorial Sloan-Kettering are studying a different kind of genetic error involved in prostate
cancer. Instead of two copies of a gene, some cancer cells have too many or too few, known as copy-number
alterations.
In a study in the journal Cancer Cell last week, the researchers analyzed the copy-number alterations in 218
cancerous prostates surgically removed at Sloan-Kettering and found that they fell into six clusters. Those
clusters corresponded closely with how quickly the patients' cancer returned, judging by their PSA.
"It was a surprise to us that so much prognostic information was there in the original samples after surgery," Dr.
Sawyers says. Ideally, "we'd be able to tell a man, 'Your tumor looks like it's in cluster five, so you should get
surgery and radiation and perhaps even more aggressive therapy. Or, you are in cluster two, so you can relax and
maybe just get another biopsy in another year and see if your cluster has changed," he says.
Tracking Patients
Further testing at Sloan Kettering is continuing. The researchers have 1,000 additional samples from prostates
removed more than 10 years ago and can correlate their findings with how the patients fared in that time.
In still another recent breakthrough, researchers at Harvard Medical School identified a gene pathway directly
involved in prostate-cancer metastasis. They isolated a gene, DAB2IP, that acts as a brake for cancer. When too
Previously
The Man, the Gland, the Dilemmas (3/31/2009)
Prostate Cancer: Weighing Options (4/7/2009)
Health Matters: Weighing the Benefits of
'Watchful Waiting' for Prostate Cancer
(4/17/2009)
much of an enzyme, EZH2, is present, the DAB2IP gene is suppressed, removing the brake and allowing the
cancer to spread.
"It's more than just correlation; it's cause and effect," says lead researcher Karen Cichowski, a cancer biologist,
who demonstrated the process in mice in a study in Nature Medicine this year. The Harvard researchers also
studied data from human prostate cancers and found that the patients with the most aggressive tumors had
either excess EZH2 or too little DAB2IP or both.
These findings, too, could yield tests to predict how aggressive a patient's prostate cancer could be. Several
biotech companies have drugs in the works to inhibit EZH2.
The various research findings complement each other by describing different ways that genes mutate as cancers
evolve, says Dr. Chinnaiyan. He expects that diagnostic tests in the future will look at a variety of genes, as well as
proteins, molecules and other "biomarkers" to predict how aggressive a cancer might be.
Another technique being applied to prostate cancer involves
magnetic resonance spectroscopy, a form of imaging that tracks
chemical changes in tissues. In a small study in the journal
Science Translational Medicine this year, researchers at
Harvard showed that the scanning technology can not only
locate cancers within the prostate, but also has the potential to
distinguish fast and slow-moving cancers.
Progress is also being made on ways to measure prostate cancers through simple blood and urine tests, or what
scientists call "liquid biopsies." The biotech firm Gen-Probe Inc., working with the University of Michigan
researchers, has developed a test for a gene called PCA3 that shows up in urine only when a man has prostate
cancer.
For now, the PCA3 test is mainly useful to tell men who have a rising PSA level that they should have a biopsy as
well, or for men who have a negative biopsy that might have missed cancer. Dr. Chinnaiyan hopes the PCA3 test
can also check for gene fusions that can identify which type of prostate cancer a man has.
'Liquid Biopsies'
The PCA3 test is not yet approved by the Food and Drug Administration, but it is approved for use in Europe and
is available in several U.S. labs on an investigational basis.
In other prostate-cancer news, there's more evidence that cholesterol-lowering statin drugs may play a role in
controlling the spread of prostate cancer. In a study in the journal Cancer, researchers at Duke University
Medical Center and elsewhere analyzed the records of 1,319 men who had their prostates removed between 1988
and 2008 and found that 304 of them had a rising PSA level after surgery, which generally indicates that the
cancer has reoccurred and spread. Men who were taking the equivalent of 20 mg of simvastatin a day were 43%
less likely to see a recurrence. In men taking a higher dose, the risk of recurrence was reduced by 50%.
The researchers cautioned that the reduced risk could be due to factors other than statins, such as diet, exercise
or smoking habits; only a randomized clinical trial could tell for sure. Five other recent studies also have found
that statins appear to lower the risk for advanced prostate cancer.
Write to Melinda Beck at HealthJournal@wsj.com
Copyright 2009

Scholz Cmment on PCa Screening

2010-06-28T13:50:00.000-07:00

Dr. Mark Scholz Comments on Recently Published Studies of the Effectiveness of PSA Screening. Re: Letter to the Editor Regarding a Wall Street Journal Article titled:
Two Big Studies Tackle Debate on Prostate Test published on Thursday March 19, 2009

The Wall Street Journal recently published a letter to the editor under the heading, “Lifestyle Is Fine, but Cancer Needs Effective Treatment.” The physician writing the letter vilified the idea of using anything but surgery to treat his prostate cancer. Unfortunately, his uninformed convictions are prevalent throughout the medical community. Now definitive, well-performed studies unequivocally prove that overtreatment is the norm (New England Journal of Medicine 2009;360:1310-9 and 1320-8) .

As has been the case for years, the a priori assumption that “all cancer needs treatment” has confused the expert commentators who are interpreting these crystal-clear study results as being part of an ongoing unresolved controversy about PSA testing. The reality is that huge amounts of precious research dollars are being spent to answer a foolish question. Whether or not to do PSA testing is not the issue. The issue is deciding what to do with the information the PSA provides.

Right now the nation is in the grip of 8-billion dollar industry hell-bent on administering treatment to every kind of prostate cancer whether it is life-threatening or not. The solution to the problem of over-treating prostate cancer is not less PSA testing. The solution is educating physicians to forgo recommending immediate surgery or radiation to every last man who gets a diagnosis of prostate cancer.

Newly-diagnosed patients need to research all their options before agreeing to irreversible radical treatment. PSA testing (in conjunction with other means) has a useful role in determining which men harbor the more aggressive types of prostate cancer. Only with a “go slow” approach, ongoing monitoring known as Active Surveillance, can we distinguish men with aggressive disease who need treatment from men with indolent disease who don’t need treatment.

Mark Scholz, M.D.
Prostate Cancer Research Institute
Los Angeles, California
MATERIAL PROVIDED BY PCRI IS INTENDED FOR EDUCATIONAL PURPOSES AND SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE

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Chemo Drug Jevtana Wins FDA Approval

2010-06-18T15:06:00.000-07:00

Today's Wall St Journal reports that the new chemo drug Jevtana, manufactured by the French drug company Sanofi-Aventis has received FDA approval under its priority review program, 3 months ahead of schedule. Its safety & effectiveness were established in a single 755-patient study. The goal of the study was human survival time. Jevtana along with a steroid achieved a survival time of 15.1 months, compared with only 12.7 months achieved with chemo drug mitroxantrone plus the same steroid

NIH Supporters Also Support FDA

2010-06-04T20:27:00.000-07:00

ANALYSIS AND COMMENTARY
NIH-oriented patient and research advocacy groups were key to the founding of the Alliance for a Stronger FDA and make up a third of the Alliance’s board. Our membership from this stakeholder group has grown over the last couple of years as more organizations recognize that “the very best NIH, even well-funded” is still limited in its impact unless new therapies are approved by FDA. An Alliance member asked us this week if we could send over a few talking points on the theme: NIH advocates need to be FDA advocates. Here is an edited version of what we provided.

Billions of dollars are spent on biomedical research at NIH and academic health centers and by biopharmaceutical and medical device companies. While much remains to be done, there have been some great successes and a lot of progress. Patients, clinicians and researchers need to be leaders in advocating for increased funding of NIH.

Through public and private funding, patient care has also come a long way as a result of advances in medical knowledge derived from research. The combination of centers of excellence and networks of community providers has advanced treatment to the point that most patients can expect to receive treatment based on the latest research and up-to-date protocols. Patients, clinicians and researchers have also been strong supporters of efforts to translate new knowledge into better care.

In between the promise of research and the benefits of improved care … lies the US Food and Drug Administration, which must consider and approve all new medical therapies that involve drugs, biologics and devices.

The patient and research advocacy community have a large stake in a strong, well-funded and effective FDA. Patients and family members want breakthroughs to move quickly to the clinic, so improved care is available sooner. They also want thorough reviews to assure that patients are not exposed needlessly to treatments that don’t work or are unsafe.

To accomplish this, FDA needs to be strengthened as an institution to assure that there are more scientists, statisticians and clinicians at the agency to review applications for new treatments. Otherwise the fruits of research may never make their way to patient bedsides.

Leading the charge for better FDA funding is the Alliance for a Stronger FDA, a broad coalition of consumers, patients and industry that has come together to advocate for more appropriated funds for the Agency. Increases in FDA’s budget would:

allow the FDA to provide faster and safer approval of products that are saving lives and transforming health care;
promote new drug technologies that will revolutionize pharmaceutical therapies
ensure continued U.S. leadership in drug innovation;
enhance the surveillance capability over new drugs once they reach the market; and
further integrate emerging science into the regulatory process.
All patients benefit when FDA has more resources.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.

Low Dose Nitroglycerin for Prostate Cacer

2010-06-01T20:08:00.000-07:00

KINGSTON, ONTARIO -- (Marketwire) -- 02/04/10 -- Treatment of prostate cancer using a very low dose of nitroglycerin may slow and even halt the progression of the disease without the severe side effects of current treatments, Queen's University researchers have discovered.

The findings are the result of the first-ever clinical trial using nitroglycerin to treat prostate cancer.

The 24-month, Phase II study targeted 29 men with increasing levels of prostate-specific antigen (PSA) following prostate surgery or radiation. PSA levels are a key predictor of cancer progression.

"We were very excited to see a significant slowing in the progression of the disease as evidenced by the men's PSA levels, and to see this result in many of the men who completed the study," says Dr. Robert Siemens of Queen's Department of Urology, who led the study.

The researchers are encouraged by the results, particularly because safe and effective treatments for men with rising PSA levels following surgery or radiation are limited. They note that further testing needs to be done to confirm the results of this very small study.

The men were treated with a low-dose, slow-release nitroglycerin skin patch and their PSA levels monitored. Of the 17 patients who completed the study, all but one showed a stabilization or decrease in the rate of cancer progression, as measured by their PSA Doubling Time.

Nitroglycerin has been used at significantly higher doses for more than a century to treat angina. This trial was based on a key finding from pre-clinical research carried out at Queen's, which showed that decreases in nitric oxide play an important role in tumor progression and that this progression can be stopped by low-dose nitroglycerin.

Prostate cancer is diagnosed in approximately 235,000 men per year in the United States and 20,700 in Canada. Of patients who have undergone radical prostatectomy and/or radiation treatment, it is estimated that 30 to 50 percent will experience a recurrence of cancer.

Results of the study, conducted by Queen's University researchers Robert Siemens, Jeremy Heaton, Michael Adams, Jun Kawakami and Charles Graham, appeared in a recent issue of the journal Urology.

Research into the use of nitroglycerin and similar compounds for the treatment of cancer by Drs. Adams, Graham and Heaton has resulted in the issue of 10 patents worldwide. PARTEQ Innovations, the technology transfer office of Queen's, has licensed some of this intellectual property to Nometics Inc., a Queen's spinoff company, which is developing products and therapies based on this and related research.

"This peer-reviewed research is our first clear clinical evidence that low-dose nitric oxide therapy offers prostate cancer patients a new non-invasive treatment option," says Robert Bender, CEO of Nometics. "It is our intention to start broader clinical trials in 2010 to confirm and expand these results."

Contacts:
PARTEQ Innovations
John Molloy

Provenge Update

2010-05-26T14:29:00.000-07:00

Thursday, April 29 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday granted approval to Provenge, a therapeutic vaccine aimed at preventing the spread of prostate cancer in men with an advanced form of the disease.

The new approval is limited to "the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment," the FDA said.

"The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available," Dr. Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release.

Proveneg appears to extend survival in men with advanced prostate cancer, and it does so without the serious side effects associated with chemotherapy, radiation and hormone therapy.

The vaccine is not aimed at preventing prostate cancer in men who have not developed the disease, and it is far from a cure for those who have it, Lichtenfeld stressed. "Provenge represents a modest advance in survival for patients with advanced prostate cancer, but the drug doesn't delay the progression of the disease," he said.

The hope is if a vaccine is effective in late-stage disease that it is going to be even more effective in the earlier treatment of that same disease," he said.

It will only have a modest impact on prostate cancer survival, but it's small changes in treatments over time that add up to a major improvement. So I wouldn't be discouraged by what is a small increment in survival.

Provenge is a therapeutic (not preventative) vaccine that is made from the patient's own white blood cells. Once removed from the patient, the cells are treated with the drug and placed back into the patient. These treated cells then cause an immune response, which in turn kills cancer cells, while leaving normal cells unharmed.

According to the FDA, Provenge is given intravenously in a three-dose schedule delivered in two-week intervals.

The vaccine was developed by Seattle-based Dendreon Corp., which conducted initial studies among men with advanced prostate cancer who had already failed standard hormone treatment. Among these men, Provenge extended life by an average of 4.5 months, although some patients saw their lives extended by two to three years. The only side effects were mild flu-like symptoms, according to the study results.

The FDA noted that in one study, men taking Provenge had a slightly higher risk for cerebrovascular events, such as stroke, with 3.5 percent of those taking Provenge suffering such events versus 2.6 percent of those who did not take the drug.

Dr. Mark Soloway, professor and chair of urology at the University of Miami Miller School of Medicine, said that "we certainly need the opportunity for our patients to have alternatives. The big question, according to Soloway, is when do you use Provenge? Whether it should be used before chemotherapy or hormone therapy isn't clear,

"There are problems with Provenge," Soloway said. "One is that it's very cumbersome, because patients have to provide their white cells, and I think that's on a regular basis. And two, it's likely to be very expensive." Costs are expected to total $75,000 for the full regimen, experts say.

Soloway agreed that Provenge might also be useful in earlier-stage prostate cancer, but studies are needed to prove that.

However, "once it's approved, it's on the market, and with proper informed consent you can use it for localized [early stage] prostate cancer. Whether insurance companies will pay for it is also not known," Soloway said.

Other new drugs to treat prostate cancer, such as Abiraterone, which prevents the production of the male hormone testosterone, are on the horizon and will compete with Provenge for new treatment regimens, he added.

According to American Cancer Society estimates, more than 192,000 new cases of prostate cancer are diagnosed in the United States each year, and 27,360 men die from the disease.

Prostate cancer is the most common form of cancer diagnosed in American men, after skin cancer. More than 2 million American men who have had prostate cancer at some point are still alive today. The death rate is going down, and the disease is being found earlier, according to the cancer society.

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PCF Report on Gene Fusion as Cause of PCa

2010-05-26T14:13:00.000-07:00

"Our study shows the underlying problem in prostate cancer is the presence of a gene fusion, not the androgen receptor," Chinnaiyan said in the news release. "In many contexts, androgen signaling is actually a good thing, but the presence of the gene fusion blocks androgen receptor signaling, which alters normal prostate cell development. While current treatments for advanced prostate cancer are focused on hormone deprivation and are quite effective, at least initially, future therapies need to be developed that target the prostate cancer gene fusion."

By using high-tech genetic mapping techniques, the research team found that once fusion takes place, androgen receptors get blocked, in turn cutting off normal prostate cell growth while permitting cancer to spread.

Back to Research

Dr Walsh on Selecting a Surgeon for Your PCa

2010-05-19T19:59:00.000-07:00

Johns Hopkins Health Alert

Advice From Dr. Walsh on Finding the Right Prostate Cancer Surgeon
Comments (1)

Dr. Patrick Walsh, former director of Johns Hopkins’s Brady Urological Institute, shares his insights on choosing a doctor for your cancer surgery.

Dr. Patrick Walsh, dean of prostate cancer surgeons, has performed the technically challenging radical prostatectomy procedure thousands of times, and has personally schooled hundreds of surgeons in the finer points of the difficult nerve-sparing cancer operation. He certainly knows what it takes to be an expert in curing a man of cancer, preserving bladder function, and maintaining the nerves responsible for erections. What about the doctor you’re considering for your own prostate cancer surgery?

“Your doctor may be nice and personable,” says Dr. Walsh, “a practitioner whose empathy for your condition appeals to you, which is great. But what do you know about him? He’s got a terrific bedside manner, but is he a board-certified urologist? What training has he had? Does he know and use the nerve-sparing cancer surgery techniques -- the anatomical approach to radical prostatectomy? How many of these cancer surgeries does he perform annually? What success has he had in preserving potency and continence? If he can’t or won’t give you his rate of success as compared to reports from other surgeons, or to results published in medical journals, this may be a red flag, and perhaps you should look elsewhere for your cancer surgeon.

“You should be able to get a good idea of his success rate in numbers or percentages. In addition, if he hasn’t done very many of these cancer operations -- ideally, hundreds -- you might want to find a more experienced surgeon. Look at it this way: Do you want to be one of the patients he’s learning on? Do you want to be part of someone’s learning curve?

“Remember: You don’t want a surgeon who’s ‘pretty good’ at removing the prostate. There are no second chances here: This is a one-shot operation. You are looking for the one surgeon who will perform the one radical prostatectomy you will ever receive in your life, the one operation that will cure your cancer.

“You want a surgeon who is going to make sure that no cancer is left behind, and who knows how to minimize trauma to your body during surgery so you don’t wind up with incontinence, erectile dysfunction, or both.

“Finding the right surgeon may mean that you must travel to a major medical center in another city. This may mean that you’ll be away from home for four days. But after that, even though you may need to wear a catheter for a week or two, the recovery from the operation is usually speedy, and follow- up communication can be carried out over the telephone.