While Provenge (Sipuleucel-T) is not yet FDA approved, it may be available in a new Dendreon-sponsored multicenter, open label (no placebo), phase 2 study of men with metastatic castrate-resistant prostate cancer if a man fits the criteria to be eligible. (Note: This trial is different from the previous ProACT trial, which used lower concentrations of Sipuleucel-T, and required that men live close to the trial site). The trial is also available to men who received placebo during the previous trial.

Some basic criteria (see link below for the full list) for being considered include having:

Metastatic disease
Castrate-resistant prostate cancer (this means men who no longer respond to surgical or medical castration, such as hormone therapy)
PSA of at least 5.0 ng/mL
Castrate level of testosterone (less than 50 ng/dL) achieved via medical or surgical castration
Life expectancy of at least 3 months
Adequate hematologic, renal and liver function
No lung, liver, or brain metastases
It must also be at least 28 days since a man has: used systemic corticosteroids (use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, less than or equal to 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans); used non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide); had external beam radiation therapy or major surgery requiring general anesthetic; had any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace), diethylstilbestrol (DES), and ketoconazole; received chemotherapy; or had treatment with any other investigational product.

Amercican Urologicall Assn Guidancw on Acewwning

The American Urological Association (AUA) and the AUA Foundation believe that early detection of and risk assessment for prostate cancer should be offered to asymptomatic men 40 years of age or older who have a life expectancy of at least 10 years. Men who wish to be screened should have both a prostate-specific antigen (PSA) test and a digital rectal exam (DRE). This program will provide information to learn more about the pros and cons of prostate screening. Program Objectives: 1 Discuss prostate screening and common prostate conditions 2 Identify current AUA recommendations for prostate screening-PSA and DRE tests 3 Describe the role of the following factors in prostate screening: free an d total PSA patient age PSA velocity PSA density family history ethnicity prior biopsy history the impact of other health conditions on prostate screening 4 Explain the prostate biopsy procedure 5 Identify questions to ask health care providers regarding individual prostate screening benefits and risks Participants in the live program will have an opportunity to present questions to the speaker panelat the conclusion of the program. This forum will be recorded for future online viewing. Meeting Organizer/Moderator: Stephanie Chisolm, PhD, AUA Foundation Mark your calendar for future Webinars in the series: Living with Prostatitis Tuesday, September 15, 2009 8-9:30 p.m. ET Featured Medical Expert: Anthony Schaeffer, MD, Feinberg School of Medicine,Northwestern University, Chicago, IL Enlarged Prostate or Benign Prostatic Hyperplasia Tuesday, September 22, 2009 8-9:30 p.m. ET Featured Medical Expert: Claus Roehrborn, MD, Department Head of the University of Texas Southwestern Medical Center in Dallas, TX, and member of the AUA Guidelines Panel for Benign Prostatic Hyperplasia

More Information on Vitamin D Resuts

I know I sound like a broken record and you may tire of my beating the drum for vitamin D But maybe this is my one good deed in life...I hope staying alive is not off topic for some groups.

Henry

November 17, 2009
Heart disease, stroke, heart failure, and premature death all linked to insufficient vitamin D levels

The
results of a study presented on November 16, 2009 at the American Heart
Association's Scientific Conference in Orlando, Florida, confirmed a
strong association between the presence of reduced vitamin D levels and
a greater risk of coronary artery disease, stroke, heart failure and
dying over follow-up in men and women 50 years of age and older.
Brent
Muhlestein, MD and his colleagues at Intermountain Medical Center in
Salt Lake City followed 27,686 subjects with no history of heart
disease for an average of 1.2 years. Serum 25-hydroxyvitamin D levels
obtained during routine clinical care were classified as normal at over
30 nanograms per milliliter (ng/mL), low at between 15 to 30 ng/mL or
very low at less than 15 ng/mL.
Over
the follow-up period, 2,614 participants developed coronary artery
disease, 1,742 developed heart failure, 314 experienced a stroke and
1,193 deaths occurred. Those with very low vitamin D levels were 45
percent likelier to develop heart disease, twice as likely to develop
heart failure, 78 percent more likely to experience a stroke,and 77
percent likelier to die than those with normal levels. Subjects whose
vitamin D levels were classified as "low" as opposed to "very low" also
had greater risks of these conditions, however, the increase compared
to those with normal levels was not as great as the very low group.
"This
was a unique study because the association between Vitamin D deficiency
and cardiovascular disease has not been well-established," commented Dr
Muhlestein, who is the director of cardiovascular research of
Intermountain Medical Center's Heart Institute. "Its conclusions about
how we can prevent disease and provide treatment may ultimately help us
save more lives."
"Utah's
population gave us a unique pool of patients whose health histories are
different than patients in previous studies," he remarked. "For
example, because of Utah's low use of tobacco and alcohol, we were able
to narrow the focus of the study to the effects of vitamin D on the
cardiovascular system."
"We
concluded that among patients 50 years of age or older, even a moderate
deficiency of Vitamin D levels was associated with developing coronary
artery disease, heart failure, stroke, and death," noted coauthor Heidi
May, PhD, MS, who is an epidemiologist with the Intermountain Medical
Center research team. "This is important because vitamin D deficiency
is easily treated. If increasing levels of vitamin D can decrease some
risk associated with these cardiovascular diseases, it could have a
significant public health impact. When you consider that cardiovascular
disease is the leading cause of death in America, you understand how
this research can help improve the length and quality of people's
lives."
"We
believe the findings are important enough to now justify randomized
treatment trials of supplementation in patients , Vitamin D
deficiency to determine for sure whether it can reduce the risk of
heart disease," Dr Muhlestein added.

Jim Mcguiness, Man to Man,Melbourne, FL

Prostate Forum Announcement

Dr Charles Snuffy Myers now focuses his popular Prostate Forum monthlyreport on answering individual prostate cancer survivor questions. His last 2 -3 monthly Forums have been really great! A yearly subscription to the Prostate Forum is quite inexpensive. His daughter Jessie, who wrote this letter, can explain further

Dear Prostate Forum Subscriber,

We're working on an upcoming issue of Prostate Forum that focuses on
readers' questions about active surveillance, commonly called watchful
waiting. If you've got a question about active surveillance, please submit
it via our website at http://www.prostateforum.com/ask-dr-myers.html or
e-mail me directly at jessica@prostateforum.com

Keep in mind that the way you ask your question is essential. If you¹re
asking about your own cancer, and not, for example, why Dr. Myers suggests
prostate cancer patients avoid flaxseed, he needs enough information about
your specific case to address it in an informative manner. Specifically, he
needs to know what kind of prostate cancer you have and how extensive that
cancer was at diagnosis. He also needs to know about each treatment in
detail and what that treatment did to your PSA or other evidence of disease.

As you formulate your questions, please be sure to include as much of the
following as possible:

* What was your PSA at diagnosis and how fast was that PSA increasing?
* What was your Gleason on biopsy?
* For all patients, PSA doubling time is very, very important. Please
estimate or provide Dr. Myers with a series of PSA levels so he can
calculate.
* Please mention if you have any other medical problems such as heart
disease.

Best,
Jessica Myers-Schecter

News You Can Use, UsTOO International

• MINIMALLY INVASIVE PROSTATE SURGERY MAY HAVE PROS AND CONS
  CancerConsultants.com, 10/15/2009
  
  Laparoscopic radical prostatectomy, a less invasive surgical procedure that has gained in popularity in recent years, appears to result in shorter hospital stays, fewer blood transfusions, and fewer postoperative respiratory complications than open, retropubic radical prostatectomy, but higher rates of incontinence and erectile dysfunction. These results were published in the Journal of the American Medical Association.
• ADDITION OF ANDROGEN DEPRIVATION THERAPY IMPROVES SURVIVAL WITH LOCALLY ADVANCED PROSTATE CANCER
  CancerConsultants.com, 10/08/2009
  
  In men with locally advanced prostate cancer, the addition of androgen deprivation therapy to radiation therapy improves overall and progression-free survival without substantially affecting cardiovascular mortality. These results, based on close to 10 years of follow-up, were presented at a European cancer conference.
• HORMONE THERAPY IN PROSTATE CANCER INCREASES RISK OF HEART DISEASE
  CancerConsultants.com, 10/06/2009
  
  Hormone therapy used to treat men with advanced prostate cancer may lead to an increased risk of heart disease, according to the results of a study presented on September 22, 2009 at Europe’s largest cancer congress, ECCO 15-ESMO 34, in Berlin.

Importance of Vitamin D to Men & Womens Health

Most on this list have already come to these conclusions and along with Dr. Cannell of VitaminDcouncil.org believe that the only way to know what your serum vitamin D is a blood test. That being said I for the life of me can not understand why people on their own won't fork out the $30 to get the vitamin D test done on their own. I have even offered to pay for the test on a bet that if they are above 50 ng/ml I pay - below they pay. I get responses like I have a physical next July I'll as the doctor what he thinks. My wife says I'm too pushy. Oh Well I try.

Henry

Heart and Bone Damage from Low Vitamin D Tied to Declines in Sex Hormones

15 November 2009 Filed under Heart health, Hormones, Osteoporosis, Vitamin D Posted by admin » No Comments

Researchers at Johns Hopkins are reporting what is believed to be the first conclusive evidence in men that the long-term ill effects of vitamin D deficiency are amplified by lower levels of the key sex hormone estrogen, but not testosterone.

In a national study in 1010 men, to be presented Nov. 15 at the American Heart Association’s (AHA) annual Scientific Sessions in Orlando, researchers say the new findings build on previous studies showing that deficiencies in vitamin D and low levels of estrogen, found naturally in differing amounts in men and women, were independent risk factors for hardened and narrowed arteries and weakened bones. Vitamin D is an essential part to keeping the body healthy, and can be obtained from fortified foods, such as milk and cereals, and by exposure to sunlight.

“Our results confirm a long-suspected link and suggest that vitamin D supplements, which are already prescribed to treat osteoporosis, may also be useful in preventing heart disease,” says lead study investigator and cardiologist Erin Michos, M.D., M.H.S.

“All three steroid hormones – vitamin D, estrogen and testosterone – are produced from cholesterol, whose blood levels are known to influence arterial and bone health,” says Michos, an assistant professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute. “Our study gives us a much better understanding of how the three work in concert to affect cardiovascular and bone health.”

Michos says the overall biological relationship continues to puzzle scientists because studies of the long-term effects of adding estrogen in the form of hormone replacement therapy in women failed to show fewer deaths from heart disease. Indeed, results showed that in some women, an actual increase in heart disease and stroke rates occurred, although, bone fractures declined.

The Hopkins team’s latest data were provided by analyzing blood samples from a subset of men participating in a study on cancer. That study was part of a larger, ongoing national health survey involving both men and women and was designed to compare the risk of diseases between those with the lowest blood levels of vitamin D to those with higher amounts. An unhealthy deficiency, experts say, is considered blood levels of 20 nanograms per milliliter or lower.

The men in the study had their hormone levels measured for both chemical forms of testosterone and estrogen found in blood, when each is either unattached or circulating freely, and when each is attached to a separate protein, known as sex hormone binding globulin, or SHBG for short.

Initial results showed no link between vitamin D deficiency and depressed blood levels of either hormone. And despite finding a harmful relationship between depressed testosterone levels and rates of heart disease, stroke, and high blood pressure, as well as osteopenia in men, researchers found that it was independent of deficiencies in vitamin D.

However, when researchers compared ratios of estrogen to SHBG levels, they found that rates of both diseases, especially osteopenia, the early stage of osteoporosis, were higher when both estrogen and vitamin D levels were depressed.

For every single unit decrease in ratios of estrogen to SHBG (both in nanomoles per liter), men low in vitamin D showed an 89 percent increase in osteopenia, but men with sufficient vitamin D levels had a less worrisome 64 percent jump.

Using the same measure of estrogen levels, men low in vitamin D were also at heightened risk of cardiovascular diseases, at 12 percent, compared to men with adequate levels of the vitamin, at 1 percent, numbers that researchers say are still statistically significant.

“These results reinforce the message of how important proper quantities of vitamin D are to good bone health, and that a man’s risk of developing osteoporosis and heart disease is heavily weighted on the complex and combined interaction of how any such vitamin deficits interact with both their sex hormones, in particular, estrogen,” Michos says.

Michos and her team next plan to analyze blood samples from women to see if the same results from men hold true.

Michos recommends that men and women boost their vitamin D levels by eating diets rich in fatty fish, such as cod, sardines and mackerel, consuming fortified dairy products, taking vitamin supplements, and in warmer weather briefly exposing skin to the sun’s vitamin-D producing ultraviolet light.

She points out that clinical trials are under way to determine whether or not vitamin D supplements can prevent incidents of or deaths from heart attack, stroke and other signs of cardiovascular disease.

The U.S. Institute of Medicine suggests that an adequate daily intake of vitamin D is between 200 and 400 international units, but Michos feels this is inadequate to achieve optimal nutrient blood levels (above 30 nanograms per milliliter). Previous results from the same nationwide survey showed that 41 percent of men and 53 percent of women are technically deficient in the nutrient, with vitamin D levels below 28 nanograms per milliliter.

Funding for this study was provided by the Hormone Demonstration Project, a part of the Maryland Cigarette Restitution Fund Research Grant Program at the Johns Hopkins University. Additional support was provided by the American College of Cardiology Foundation and a Clinician Scientist Award at the Johns Hopkins University.

Besides Michos, other researchers at Johns Hopkins involved in this study were Jared Reis, Ph.D.; and Meredith Shields and Elizabeth Platz, Ph.D., Sc.D., at the University’s School of Public Health; and Sabine Rohrmann, now at the German Cancer Research Center in Heidelberg. Another investigator in this research was Nader Rifai, Ph.D., at Children’s Hospital Boston and Harvard Medical School.

Role of Biopsy in Selecting Candidates for AS

Beyond the Abstract - The role of biopsy core number in selecting
prostate cancer patients for active surveillance, by Guillaume
Ploussard, MD and Alexandre de la Taille, MD

The inclusion of patients in AS protocols emphasizes the necessity of
accurate staging strategies. Should all patients submitted to prostate
biopsy be ...subjected to an extensive biopsy strategy? Only prospective
studies comparing biopsy inclusion criteria and biopsy-core number for
AS protocols and comparing AS with immediate radical treatment would be
able to clarify the best candidates for AS according to outcome in
terms of rising PSA and specific deaths. Clinicians, however, clearly
have to deal with the biopsy-core number for treatment decisions and
patient information.Read More

Watchful Waiting for older Men

Watchful Waiting Works for Older Men With Prostate Cancer But experts stress the same does not hold true for patients under 60 By Ed Edelson Tuesday, Sept. 15 (HealthDay News) -- Older men diagnosed with prostate cancer who choose watchful waiting are doing better these days than in the era before screening with a test for prostate-specific antigen (PSA) became common, a new study finds. "The most important message is that the long-term outcome for patients who don't have surgery or radiation is pretty good," said study author Dr. Grace L. Lu-Yao, an associate professor of medicine at the University of Medicine and Dentistry of New Jersey. Her report appears in the Sept. 16 issue of the Journal of the American Medical Association. That message applies only to men over 65 when prostate cancer is diagnosed. Lu-Yao and her colleagues analyzed data on 14,516 such men whose diagnoses were made between 1992 and 2002, at an average age of 78, and who did not have surgery or radiation in the next six months. The researchers followed them for an average of 8.3 years. The study separated men by their Gleason score, which measures the degree to which the prostate gland has lost its orderly structure. Greater disorder indicates greater danger from the cancer. The 10-year death rate from prostate cancer was 8.3 percent for men with the least disordered tumors. Their death rate from all other causes was 59.8 percent. For men with moderately disordered tumors, the 10-year prostate cancer-specific death rate was 9.1 percent, compared to a 57.2 percent death rate from all other causes. The prostate cancer death rate for men with the most disordered tumors was 25.6 percent, compared to 56.5 percent for all other causes. The cancer survival numbers are much better than for the pre-PSA screening era, possibly because "patients now are diagnosed at a much earlier stage compared to patients 10 and 20 years ago," Lu-Yao said. Earlier detection translates to apparent longer survival simply because the cancer has a longer time to grow. But the information in the study shouldn't be applied to younger men, Lu-Yao stressed. The best available data indicate better survival with treatment for men under 65, she said. So, the study might send the wrong message about PSA testing to those men, said Dr. Richard Greenberg, chief of urologic surgery at the Fox Chase Cancer Center in Philadelphia. "My concern is that 50-year-old men with family histories of prostate cancer will be listening to these statements that there is too much screening, so they won't have screening because they think it isn't necessary," Greenberg said. He is skeptical about watchful waiting, except in carefully selected cases. "I don't think anyone under 60 is a great candidate for watchful waiting unless they have another condition that is going to do them in within 10 years," Greenberg said. Every man diagnosed with prostate cancer should understand that watchful waiting is one possible option, he said. "But you have to individualize the decision for every patient," Greenberg said. "If they have an aggressive cancer, they should be treated aggressively. You need to be very selective when you say when a conservative approach is appropriate." Treatment or watchful waiting for cancer in men 70 and older "is an important question, but probably not the most important question," said Dr. Martin Sanda, director of the prostate cancer center at Beth Israel Deaconess Hospital in Boston. Sanda recently reported a study of younger men whose average age when they were diagnosed with prostate cancer was about 60. That study indicated that "lower-risk tumors probably can be managed with watchful waiting in men anywhere from the 40s to the 70s," Sanda said, but the key issue is the nature of the tumor. "For patients with poorly differentiated tumors, there is a fair amount of cancer deaths unless they are treated aggressively," he said. More definitive information about watchful waiting versus treatment of prostate cancers is expected from a study recently started in Canada and now being done in medical centers there and in the United States, Greenberg said. But results of that study are not expected for at least 10 years, he noted, and meanwhile men and their doctors need to make treatment decisions based on each man's characteristics. "We need to individualize these decisions, even in the elderly," Sanda said.

Why Avodart and Peoscar(Finasteride are Ignored?

Studies’ Complications

Then came the studies of finasteride and dutasteride for prostate cancer. The drugs block the conversion of testosterone to dihydrotestosterone, a hormone that prostate cancers need to grow. They are on the market to shrink the prostate in older men, whose prostates often enlarge. (Finasteride is also sold to grow hair — but the dose is one-fifth the dose that shrinks prostates and that dose has not been tested for cancer prevention.) Doctors can prescribe the drugs for cancer prevention but, at this point, that is not on their label.

The prostate cancer studies were complicated by other another factor; at first, researchers thought, erroneously, that finasteride was actually spurring the growth of aggressive prostate cancers. The drug’s side effects can include impotence or decreased ejaculate. But the Food and Drug Administration concluded that these effects, if they occur at all, are gone after a year.

Now, even though the F.D.A. deemed the drug’s adverse reactions to be “usually mild and transient.” The American Urological Association and the American Society for Clinical Oncology recommend that men 50 and older consider taking it. But there appears to be little interest even among high-risk men.

Importance of PSA Screening

From the latest research, here are seven reasons why urologists are encouraging men of any age who expect to live at least another 10 years to think hard about getting a PSA test, even if they have to pay out of pocket:

1. Keeping tabs on PSA saves lives. Many urologists flat out reject a large study published in the New England Journal of Medicine earlier this year that found men who got the PSA test did worse than men who didn't. The dissenters say the results weren't trustworthy—many of the men who weren't supposed to get tested actually did, thanks to their proactive primary-care docs. Another recent large NEJM study found that nine years after entering the study, men who got regular PSA screening were 20 percent less likely to die of prostate cancer. One model suggests the PSA test has contributed to much of the 30 percent decline in prostate cancer deaths seen in recent decades.

2. There's no magic PSA number. In the urologists' latest recommendations, it is clear that there's no one-size-fits-all age at which to be tested or bad PSA number. For many years, a particular reading of 4 or above was a battle cry that called for a biopsy or aggressive treatment. In reality, any reading is suspect. Without knowing much more about him, studies give a middle-aged man a 10 percent chance of having visible cancer on biopsy even if his PSA level is zero. Today, doctors consider a single PSA number in the context of your specific health background, race, and family history (it may also help diagnose benign enlargement or an infection), and then suggest when to be tested next. If you do get a biopsy, the criteria for serious concern are stricter, and there are more conservative treatment options.

3. Velocity matters. Your first PSA test is neither your last nor your most important. Depending on your age and your current PSA number, the question is how much, and how fast, subsequent test numbers increase. Researchers are busy determining just how much velocity is normal. (Some researchers say a speed bump of more than 0.25 in one year for a 40-year-old man should prompt concern.) Every man generates a history of data points his doctors can interpret in light of the research.

4. There ' s more than one kind of PSA to measure . Enlarged but noncancerous prostates usually release "free" PSA that circulates through the body, while PSA produced by cancer cells tends to attach itself to proteins in your blood. By considering the ratio of the types of PSA, as is done by looking at the ratio of bad to good cholesterol for heart disease, doctors can offer you better advice about your risk and what you should do next.

5. The younger you are, the more meaningful the PSA test. Older prostates tend to get bigger and put out more PSA, complicating interpretation. Higher PSA levels at a younger age are an indicator of elevated risk and call for closer monitoring of factors like your PSA velocity. At the same time, prostate cancer therapies are most effective and sparing of function when the cancer is at an early stage.

6. PSA numbers reveal your prognosis and are critical in follow-up. If you do develop a serious form of prostate cancer that requires aggressive treatment, your PSA levels prior to treatment will help your medical team determine the risk of recurrence. It's one factor among many others, such as how the tumor looked under the microscope after surgery, but the latest studies show it's of real value. After surgery to remove the prostate, the PSA test is even more critical: Detection of extremely minute levels can signal cancer recurrence. The earlier doctors know the cancer is back, the earlier patients can decide about secondary treatments like radiation and hormonal therapy.

7. For now, PSA is the best we've got. Scientists are looking hard for a better "biomarker" than the PSA, ideally one that doesn't require so much deliberation. Candidates are surfacing, but they require more proof. Physical measures like the prostate's size can be misleading, as Mayo Clinic researchers reminded us this week. Studies show that a digital rectal exam plus a PSA test is the surest way to pick up prostate cancer. But if you've got to pick only one test, PSA is still the best.

Tags: prostate cancer

Woodbridge Relay for Life, May 15-16,2009

Support “Relay for Life”

The next Woodbridge “Relay for Life” will be May 15-16, 2010. Planning is well under way and teams of participants are forming. “Relay for Life” is a great way to join together in the cause of fighting cancer and is also a special way to celebrate our “Survivorship.”

Since Jim Kearns has advanced prostate cancer and his son and two grandsons are at significant risk, he has formed a team with them. They call themselves the “Galway Boys.” “Galway” for the county in Ireland where the Kearns family originated and “Boys” in note of the risk the boys in the Kearns family have. According to their team page, their focus is on “the fight against prostate cancer.” And they welcome “members of the local chapter of ‘Us TOO International’ and others to join them.

The “Galway Boys” home page is located at: http://main.acsevents.org/site/TR?pg=team&fr_id=24958&team_id=561179

You can join the “Galway Boys,” donate via the “Galway Boys” team, start your own team, join another team (Jim Viggiani also has a team), or participate or donate as an individual. Whichever option you choose, please support “Relay for Life.”

For more information, contact Jim Kearns on 703-670-7440 or via e-mail at: jkearnsjr@verizon.net.

STORY HIGHLIGHTS

• Spokeswoman confirms Andrew Lloyd Webber has prostate cancer
• Condition in its "very early stages," according to spokeswoman
• Award-winning composer has produced more than a dozen musicals

(CNN) -- Andrew Lloyd Webber, the award-winning composer and producer of more than a dozen musicals including "The Phantom of the Opera" and "Cats," has been diagnosed with prostate cancer, a spokeswoman said Sunday.

"The condition is in its very early stages. Andrew is now undergoing treatment and expects to be fully back at work before the end of the year," the spokeswoman said in a written statement from the London-based public relations firm Brown Lloyd James. They released no further details.

Dr Samadi Recommends PSA Screening,

NEW YORK, NY--(Marketwire - November 10, 2009) - In a recent New York Times article, the American Cancer Society (ACS) ignited a major controversy over the benefits of cancer screening, specifically with regards to their breast and prostate cancer guidelines. In the article, Dr. Otis Brawley, chief medical officer of the ACS, responded to a study in the current issue of the Journal of the American Medical Association. The study, conducted over the last 20 years of screenings for breast and prostate cancer, concluded that detection of early stage disease nearly doubled for both cancers, but this early detection did not result in more patients being cured.

Dr. Brawley shared his conclusion that current cancer screening methods are not perfect. He further suggested that the advantages of screening guidelines might have been exaggerated. A subsequent clarification from the ACS stated that screening should continue to be done, but patients need to understand that current screening methods are not certain.

While the ACS is continuing to research their cancer screening guidelines, they are not changing them just yet, and neither is Dr. David Samadi, Chief of the Division of Robotics and Minimally Invasive Surgery in the Department of Urology at The Mount Sinai Medical Center. Dr. Samadi's recommendation has and will always be to encourage regular prostate cancer screenings for men over the age of 50. For those men with a family history of prostate cancer, the recommended age drops to 40. "This is no longer an old man's disease," said Dr. Samadi.

Dr. Samadi has long acknowledged that there is no perfect screening method for prostate cancer. And while the ACS does not recommend prostate-specific antigen (PSA) testing for all men, because many studies have determined that the PSA has not been successful in preventing prostate cancer deaths, it does suggest that men make an informed decision about prostate cancer screening with their doctor. Dr. Samadi wholeheartedly agrees with this suggestion, and continues to advocate prostate cancer screening, particularly in men who have known risk factors.

As an oncologist who is also an expert in open, laparoscopic and robotic surgery, Dr. Samadi does not rely on the PSA test alone in making a diagnosis of cancer and prescribing treatment. He conducts an individualized analysis of his patients utilizing a combination of markers, including digital rectal exams and Gleason scores. Even normal scores in these exams can be used as baselines to monitor future fluctuations that can indicate prostate cancer in its early stages.

"Patients who partner with their doctor to monitor these fluctuations and any other risk factors can successfully stay ahead of this disease," said Dr. Samadi, who has successfully performed over 2,100 robotic prostatectomy surgeries. Cancer grows at different rates, but Dr. Samadi believes that a diagnosis of prostate cancer is not necessarily a death sentence. However, he advocates surgery because it is only by removing the prostate that the cancer range, stage and rate can be fully ascertained.

In his own response to the controversial study, Dr. Samadi noted that the study, which took place over the last 20 years, would have a radically different outcome in today's world of cancer treatment. Due to advances in technology and surgical experience, robotic surgery has become the ideal treatment option as it is less invasive than the older modalities, and provides the surgeon a higher level of magnification and mobility. This results in cure rate of over 95%, along with reduced rates of the dreaded side effects of prostate surgery, such as impotence and incontinence.

If left untreated, prostate cancer can spread outside of the gland, making treatment and recovery more complicated and requiring follow-up surgeries. These end up increasing healthcare costs. Dr. Samadi believes in prostate cancer screening and treatment because it's effective. He maintains that there have been definitive decreases in advanced-stage cancers and age-specific prostate cancer mortality rate in the "PSA screening era." This is why Dr. Samadi asks: "Why take a chance with a silent killer when a proactive approach can reduce healthcare costs and save your life?"

Provenge Update

The company said it expects demand for Provenge to outstrip supply at launch, so doctors who participated in the Provenge phase III studies plus leading academic medical centers will be the first to prescribe the cancer vaccine to their prostate cancer patients.

All advocates should join the call for expedited approval from the FDA! The FDA promised CareToLive three times in its response to our Citizen Petition that it would expedite review as soon as it received all the data from Dendreon. They have all of the data as of October 30, 2009. This is not a new application. It is an amended (aBLA) application of the original filed in November 2006.

According to the FDA itself this has been an ongoing process since November 2006. The time for approval is now! They can get the review done quickly if they want to...and why shouldn't they want to.

Kerry M. Donahue
6295 Emerald Parkway
Dublin, Ohio 43016

Testosterone Levels & Metastatic Prostate Cancer

Department of Urology, Santo Spirito Hospital, Casale Monferrato, Alessandria, and Department of Biometry, Ibis Informatica s.r.l., Milan, Italy.

OBJECTIVE To determine if the testosterone level achieved with androgen-deprivation therapy (ADT) is directly related to survival and risk of death in men with metastatic prostate cancer, as agonistic analogues of luteinizing hormone-releasing hormones (LHRH) are indicated for palliative treatment of these patients, but there is no consensus about the utility of serum testosterone measurements during the follow-up, and their possible prognostic value. PATIENTS AND METHODS We retrospectively reviewed 129 consecutive patients with a histological diagnosis of metastatic bony-only prostate cancer and previously untreated with ADT. They were treated with 3 months of goserelin. Testosterone and prostate-specific antigen (PSA) levels were measured in all patients every 3 months for the duration of the follow-up. The following variables were recorded: age, stage, Gleason score, basal PSA level, basal testosterone level, PSA nadir, time to PSA nadir, testosterone after 6 months, testosterone nadir and time to testosterone nadir. Data were analysed using Cox's proportional hazards models, with the primary endpoint being cancer-specific survival. RESULTS The mean (sd) basal PSA level was 185.8 (344.1) ng/mL, and the mean nadir PSA level 2.7 (8.6) ng/mL. The mean testosterone levels at baseline, 6 months and the nadir were 440 (200), 40 (40) and 21 (15) ng/dL. With a mean follow-up of 47.5 (29.7) months, 71 patients were dead (55%) and 78 were alive (45%) at the time of analysis. Statistical analysis using Cox's model showed that in these patients the risk of death was directly correlated not only to Gleason score (P <>

PMID: 19747358 [PubMed

Armstrong AJ, Febbo PG.

Department of Medicine and Surgery, Duke Comprehensive Cancer Center, Durham, NC 27710, USA. andrew.armstrong@duke.edu

Recurrent prostate cancer has a complex molecular etiology and a prolonged disease course. Although initially responsive to androgen ablation, many men eventually become castration resistant, develop skeletal metastases, and are palliatively treated with docetaxel-based chemotherapy, radiation therapy, bisphosphonates, and best supportive care. Given the modest success rates of the current standard of care, clinical trial enrollment is encouraged. Castration-resistant prostate cancer (CRPC) is a heterogeneous disease, both in clinical manifestations and outcomes, requiring an individualized approach to both patient care and trial design. Herein, we review surrogate markers of disease progression and treatment efficacy in advanced prostate cancer in light of recently published guidelines that have redefined eligibility, response criteria, and suitable endpoints in prostate cancer drug development. The guidelines have refined outcome measures to potentially better capture clinical benefit and the ability of novel targeted molecular and biologic agents to impact favorably on this disease. We consider prostate-specific antigen changes, circulating tumor cells, bone scan alterations, markers of bone metabolism (urinary N-telopeptide and bone-specific alkaline phosphatase), pain improvements, and progression-free survival. To illustrate the role and challenges of these potential biomarkers and endpoints in drug development, we discuss a class of novel molecularly targeted agents, the src kinase inhibitors. Given that there are currently no validated surrogate markers of overall survival for assessing early clinical benefit from systemic therapy in metastatic CRPC, incorporation of relevant biomarkers into all phases of clinical development is essential to accelerate drug development in this field.

PMID: 19684076

Armstrong AJ, Febbo PG.

Department of Medicine and Surgery, Duke Comprehensive Cancer Center, Durham, NC 27710, USA. andrew.armstrong@duke.edu

Recurrent prostate cancer has a complex molecular etiology and a prolonged disease course. Although initially responsive to androgen ablation, many men eventually become castration resistant, develop skeletal metastases, and are palliatively treated with docetaxel-based chemotherapy, radiation therapy, bisphosphonates, and best supportive care. Given the modest success rates of the current standard of care, clinical trial enrollment is encouraged. Castration-resistant prostate cancer (CRPC) is a heterogeneous disease, both in clinical manifestations and outcomes, requiring an individualized approach to both patient care and trial design. Herein, we review surrogate markers of disease progression and treatment efficacy in advanced prostate cancer in light of recently published guidelines that have redefined eligibility, response criteria, and suitable endpoints in prostate cancer drug development. The guidelines have refined outcome measures to potentially better capture clinical benefit and the ability of novel targeted molecular and biologic agents to impact favorably on this disease. We consider prostate-specific antigen changes, circulating tumor cells, bone scan alterations, markers of bone metabolism (urinary N-telopeptide and bone-specific alkaline phosphatase), pain improvements, and progression-free survival. To illustrate the role and challenges of these potential biomarkers and endpoints in drug development, we discuss a class of novel molecularly targeted agents, the src kinase inhibitors. Given that there are currently no validated surrogate markers of overall survival for assessing early clinical benefit from systemic therapy in metastatic CRPC, incorporation of relevant biomarkers into all phases of clinical development is essential to accelerate drug development in this field.

PMID: 19684076

Federal Prostate Cancer Research Funding.The charts below compare federal research funding for breast and prostate cancer at theDepartment of Defense (DOD) Prostate Cancer Research Program (PCRP) and at the NationalInstitutes of Health (NIH), primarily at the National Cancer Institute (NCI).

Funding for the DOD PCRP is provided in the Department of Defense Appropriations Bill. Congress directly funds this program annually as part of the Congressionally Directed Medical
Research Program which traditionally includes research funding for breast cancer and ovarian cancer as well.

While Congress also appropriates funding for NIH, funding for specific disease research is determined by the agency. The priorities within NIH and at NCI are not clearly affected by the politics on Capitol Hill. Funding amounts for fiscal years 2008 and 2009 are estimates based on
projected grant requests and current budget projections. Funding for fiscal year 2007 and prior are dollars actually granted.

Despite the statistics, the gap between DOD research funding for prostate cancer and breast cancer continues to widen, and with large increases in fiscal years 2008 and 2009 in the DOD program, the trend continues. The PCRP hit a high funding amount of $100 million in fiscal year 2001, but has not seen that level of funding since then.

DODBreast Cancer Funding (millions of $US) over the past 7 years: 150 150 150 127.5 127.5 138 150
DOD Prostate Cancer (Millions of $US) over the past 5 years:85 85 85 80 80 80 80

Turning now to NIH Research Funding over the last 7 years($ in millions)

Breast Cancer 698.7 ,708, 700, 718, 707, 705, 703 ($ in millions)

Prostate Cancer 398.2 378 373 348 345 344 344 ($ in millions)

Please contact Kevin Johnson, Sr. VicePresident of Public Policy at (202) 487-9455 if you have questions.Sources: National Institutes of Health and the Department of Defense.
DoD Research Funding

Hi To All,

The American Urological Association (AUA) clarifies its guidance on PSA screening. Please read closely.

Dick G

AUA Releases Statement Clarifying Prostate Cancer Testing Recommendations

The American Urological Association (AUA) today released a statement on
prostate cancer testing, clarifying the Association's recommendations and
support of early detection.

(Vocus <http://www.vocus.com> /PRWEB <http://www.prweb.com/> ) November 2,
2009 -- The American Urological Association (AUA) is aware of recent news
reports disparaging prostate cancer testing. We are concerned that these
reports are causing significant confusion for patients and we wish to
clarify our recommendations on prostate cancer testing with the
prostate-specific antigen (PSA) test and digital rectal exam (DRE). The AUA
strongly supports early prostate cancer detection and feels it is in a man's
best interest to consider being tested for prostate cancer.

Prostate cancer is most treatable when caught early. Men ages 40 and older
should be offered a baseline PSA test and DRE for early detection and risk
assessment. The future risk of prostate cancer is closely related to a man's
PSA score; men who are screened at 40 establish a baseline PSA score that
can be tracked over time. The AUA strongly supports informed consent,
including a discussion about the benefits and risks of testing, before
screening is undertaken.

According to the American Cancer Society (ACS), prostate cancer is the most
common non-skin cancer affecting men in the United States. One in six men
will be diagnosed with prostate cancer in his lifetime-more than 192,000 in
2009. It is the second leading cause of cancer death in American men.

Prior to the emergence of PSA testing, only 68 percent of newly diagnosed
men had cancer localized to the prostate and 21 percent had metastatic
disease. Today, more than 90 percent of these men have cancer confined to
the prostate and only 4 percent have cancer that has spread to other areas
of the body. U.S. deaths from prostate cancer have decreased by 40 percent
over the past decade - a greater decline than for any other cancer. While
the PSA test may be limited because it does not indicate whether a cancer is
aggressive, the test provides important information in the diagnosis,
pre-treatment staging or risk assessment, and monitoring of prostate cancer
patients. It has allowed millions of men to make informed treatment
decisions that may have saved their lives.

The controversy over prostate cancer should not surround the test, but
rather how test results influence the decision to treat. The decision to
proceed to prostate biopsy should be based not only on elevated PSA and/or
abnormal DRE results, but should take into account multiple factors
including free and total PSA, patient age, PSA velocity, PSA density, family
history, ethnicity, prior biopsy history and comorbidities.

A cancer cannot be treated if it is not detected. Not all prostate cancers
require immediate treatment; active surveillance, in lieu of immediate
treatment, is an option that should be considered for some men. Testing
empowers patients and their urologists with the information to make an
informed decision.

The above statement may be attributed to AUA Past President John M. Barry,
MD. The AUA Best Practice Statement on Prostate-Specific Antigen can be
viewed here:
http://www.auanet.org/content/guidelines-and-quality-care/clinical-guideline

Hi Friend, I want to share with you a special request from Dr. Jo-an Baldwin Peters to participate in her sexuality survey designed especially for prostate cancer survivors and their partners. Us TOO has previously published outcomes from some of Dr. Peters’ earlier research in a past issue of our monthly newsletter, the HotSheet, “Outer-course vs. Inter-course,” and we were so impressed with her work, that we wanted to let you know about her next phase of research. See below for a personal note from Dr. Peters explaining her research, and survey links. Read the article by Dr. Jo-an Baldwin Peters on sexual intimacy suggestions and tips, “Outer-course vs. Inter-course” Thank you for your consideration and participation. Sincerely, Tom Kirk President & CEO Us TOO International tom@ustoo.org