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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Sunday, August 29, 2010
Friday, August 27, 2010
National Cancer Institute's Clinical Trials
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).
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
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
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
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."
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."
Wednesday, August 18, 2010
IDing Which of the 24 Types of PCa You Have
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.
.
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.
.
Tuesday, August 17, 2010
Transdermal Estradiol Therapy for Prostate Cancer
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
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
Sunday, August 15, 2010
Introduction to the New ProstRcision Surgery
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
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
Friday, August 13, 2010
Neoadjuvant Treat ent with Taxotere
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
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
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
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.
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
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
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
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
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
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.
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
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
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
Tuesday, August 10, 2010
FDA Criticizes Dendreon's Claims for Provenge
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
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
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.
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.
Saturday, August 7, 2010
Nat'l Comprehense Cancer Network Intoduces Proventys
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News and Updates from the National Comprehensive Cancer Network® (NCCN®) July 26, 2010 | Volume 2 • Issue 15
Sign up for this Newsletter | Search Past NCCN eBulletins
Featured Articles
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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.
NC
News and Updates from the National Comprehensive Cancer Network® (NCCN®) July 26, 2010 | Volume 2 • Issue 15
Sign up for this Newsletter | Search Past NCCN eBulletins
Featured Articles
ADVERTISEMENT
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.
NC
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