Bicalutamide Reduces Risk of Prostate Cancer Progression in Adjuvant Use

ANAHEIM, CA—Preliminary results from the Early Prostate Cancer (EPC) Trial Program indicate that treatment of localized or locally advanced prostate cancer with bicalutamide can reduce the risk of disease progression by 42 percent. Researchers, reporting their results here at the 96th Annual Meeting of the American Urological Association, studied the effects of 150 mg of the drug as an immediate or adjuvant treatment for early prostate cancer. Bicalutamide is currently available in the United States in a 50 mg tablet and is approved for use in combination therapy for the treatment of Stage D2 metastatic prostate cancer. Patients were given bicalutamide or placebo following their decision to undergo radical surgery, radiation, or “watchful waiting.” Bicalutamide is an oral hormonal medication that interferes with the ability of prostate cancer cells to use male hormones to grow. The drug blocks the action of androgens, such as testosterone, at the cellular level. David McLeod, MD, Chief of Urologic Oncology at Walter Reed Army Medical Center in Washington, DC, said, “Results from the Early Prostate Cancer Trial Program so far indicate that men with earlier-stage prostate cancer may reduce the risk of their disease progressing if they are administered bicalutamide as immediate therapy.” A total of 8,113 men with prostate cancer without evidence that the cancer had spread to bone were enrolled in the trial that began in 1995. During that period, nearly one in eight men showed evidence of cancer progression—559 in those who received placebo and 363 who were administered the high-dose bicalutamide. Reductions in disease progression were observed across the entire patient population, regardless of underlying therapy or disease stage, Dr. McLeod reported, which indicates that there is a 42% comparative reduction in disease progression in those patients treated with bicalutamide. “These early results from the EPC Program are encouraging,” said William See, MD, Professor and Chief of Urology at Medical College of Wisconsin in Milwaukee and a lead investigator in the study. “The trial is still ongoing to determine the potential for survival benefits, and we hope that as time progresses the study will continue to yield promising results.” A total of 4,052 patients were assigned randomly to receive bicalutamide at 150 mg/day, while 4,061 patients received placebo tablets, in addition to standard therapy of radical prostatectomy, radiotherapy, or watchful waiting. Objective disease progression was determined by bone scan, computed tomography, ultrasound, or magnetic resonance imaging. Deaths from all causes were counted as objective progressions. While prostate-specific antigen (PSA) values were recorded, the study criteria did not use PSA progression as an indication of objective progression, Dr. See reported. Mild Adverse Effects The most frequently reported side effects of bicalutamide were gynecomastia and breast pain. Breast enlargement occurred in about two thirds of the men in the study. Breast pain occurred in about 73 percent of the patients taking bicalutamide, the researchers said. “In most patients these effects were categorized as mild or moderate,” Dr. See said. “The overall incidence of other side effects was similar for both treatment groups.” The EPC Trial Program is an international program consisting of three prospective, randomized, double-blind, placebo-controlled clinical trials. The program, which began in 1995, is the largest prostate cancer trial program ever conducted and includes patients from 23 countries around the world. A total of 3,292 patients were recruited from the United States and Canada; another 1,218 were enrolled from Scandinavian countries, and the remaining 3,603 were from the rest of Europe, South Africa, Australia, and Mexico. The program was designed to determine whether adding bicalutamide to standard care in prostate cancer can reduce the risk of disease progression when compared with standard therapy alone. “As a result of heightened awareness and wider acceptance of screening, prostate cancer is increasingly being detected at an earlier stage,” said Dr. McLeod. “The EPC Trial Program is the first significant trial to study this population and determine if adding therapy with a drug such as bicalutamide can reduce disease progression.”

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