[Overview]

The Prostate Cancer Prevention Trial (PCPT) is a Phase III, randomized, double-blind, placebo-controlled trial of finasteride for the prevention of carcinoma of the prostate. A total of 18,882 essentially healthy men, aged 55 and older, have been randomized to receive finasteride (5 mg daily) or placebo for seven years. Active participants are monitored quarterly for side effects and adherence to treatment schedule. All participants receive annual follow-up for signs or symptoms of prostate cancer; an elevated PSA value and/or an abnormal DRE at this time prompts a recommendation for a prostate biopsy. At the end of seven years of follow-up, all participants will have a prostate biopsy.

The PCPT is an intergroup study that is implemented at 219 study sites in the United States and Canada. The trial was activated on October 13, 1993 and closed to enrollment on December 6, 1996; the last participant was randomized on May 16, 1997