Purpose: The rationale, design considerations and current status of the Prostate Cancer Prevention Trial (PCPT) are presented. Materials and Methods: The design considerations for a prevention study involving finasteride were reviewed. Most notable was the end of study biopsy planned for all participants to eliminate any detection bias caused by the effect of finasteride on prostate specific antigen. Results: During a 3-year period 18,882 men were randomized in the PCPT. The final end of study biopsy is planned for May 2004. The study was closed 15 months before the final anticipated participant biopsy by the independent Data and Safety Monitoring Committee due to a 24.8% reduction in prostate cancer with finasteride. Conclusions: The extraordinary accrual of PCPT of healthy men in a prospective study to test an intervention for prostate cancer prevention illustrates the potential for future studies. The positive results of the trial as well as many observations that have been made of the study population argue for increased emphasis on prevention research for highly prevalent genitourinary malignancies.
ASJC Scopus subject areas