Implementation of the Prostate Cancer Prevention Trial (PCPT)

Control Clin Trials. 2004 Apr;25(2):203-22. doi: 10.1016/j.cct.2003.11.007.


The Prostate Cancer Prevention Trial is a randomized double blind chemoprevention trial of 18,882 men. It is designed to test the difference in the histologically proven prostate cancer prevalence between a group of participants given finasteride and another given placebo for 7 years. We present an overview of the study design, details of the administrative structure of the study and a description of the successful implementation of the accrual phase.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Chemoprevention
  • Cholestenone 5 alpha-Reductase / antagonists & inhibitors
  • Enzyme Inhibitors / pharmacology*
  • Finasteride / pharmacology*
  • Humans
  • Male
  • Middle Aged
  • Prevalence
  • Prostatic Neoplasms / enzymology
  • Prostatic Neoplasms / epidemiology
  • Prostatic Neoplasms / prevention & control*
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • Research Design


  • Enzyme Inhibitors
  • Finasteride
  • Cholestenone 5 alpha-Reductase