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Early Prostate Cancer Trial (EPC) Tests Placebo vs Bicalutamide PDF Print E-mail

Christopher P. Evans M.D. BERKELEY, CA (UroToday.com) - The Early Prostate Cancer Trial (EPC) consisted of three international groups of patients treated with either placebo or bicalutamide in addition to standard of care.

The US cohort of men primarily chose radical prostatectomy (80%) as their standard of care. Most men were in the low risk category and evidence of positive lymph nodes or metastasis was exclusion criteria.

Participants were evaluated for prostate cancer (CaP) status at trial entry and every 3 months thereafter or until disease progression. The primary trial endpoints were progression-free survival (PFS) and overall survival (OS).

A total of 3,292 men were recruited in the North American trial. Median follow-up for this analysis was 7.7 years. The median duration of therapy was 1.83 years for bicalutamide and 1.84 years for placebo (standard of care alone). There was no difference in objective progression in men treated with bicalutamide vs. placebo with the rates of objective progression 15.4% and 15.3%, respectively. Mortality rates were 12.9% in the bicalutamide patients and 12.3% in the standard of care alone patients. No differences in PFS or OS were found between the two groups. However, bicalutamide improved the time to PSA progression.

Gynecomastia was experienced in 73% and breast pain in 85% of patients treated with bicalutamide. Withdrawal rates for this were 29%, compared to 0.9% in the placebo group. These data do not support a role for adjuvant bicalutamide in this group of patients. J Urol 2006;176:75-80 

Dr. Christopher Evans is on the Board of Directors of the Society of Urologic Oncology and is active on many committees in the American Association for Cancer Research. Dr. Evans is on the Editorial Board and an Associate Editor of Prostate Cancer and Prostatic Diseases and he is a Section Editor for Current Opinion in Urology. He reviews for numerous journals including The FASEB Journal, Oncogene, Cancer Research, Urologic Oncology, The Journal of Urology, Prostate Cancer and Prostatic Diseases, Nutrition in Cancer, Journal of Clinical and Experimental Metastasis, Biochimica et, Biophysica Acta, and Urology. Dr. Evans is active in grant reviews for the American Cancer Society, the Department of Defense Prostate Program, the National Cancer Institute and the VA Merit Review Program. He is a Faculty Co-Chairman of the Annual Winter Urologic Forum and on the faculty of the Innovators in Urology International Prostate Cancer meeting. Dr. Evans professional affiliations include fellowship in the American College of Surgeons, the American Association for Advancement of Science, the American Association for Cancer Research, Southwest Oncology Group, Society of Urologic Oncology, the American Urological Association and its Western Section, Society for Basic Urologic Research and the Association of Military Surgeons of the United States. He has received numerous awards to include the Joseph F. McCarthy Essay Contest of the American Urological Association and the New York Academy of Medicine, Edwin Beer Award. Dr. Evans maintains an active research laboratory focusing on prostate cancer and specifically signal transduction regulation of the androgen receptor. He has received research funding from the National Institutes of Health, the Department of Defense, the American Cancer Society, the New York Academy of Medicine, the California Cancer Research Program, and the University of California Cancer Research Committee.  

Additional PCa information can be found at UroToday.com

 
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Medical Facts
Prostatitis -- The prostate is built like a sponge, with many pockets, called ascini. With all forms of prostatitis, these ascini become blocked and distended causing symptoms. Obviously, when bacteria are present, these blocked ascini become mini abscesses, like acne.  Similarly, some of these pockets may remain infected despite adequate antibiotic treatment causing the condition to recur.

Prostatitis