Design of the Prostate Cancer Prevention Trial (PCPT)

Polly Feigl, Brent Blumenstein, Ian Thompson, John Crowley, Michael Wolf, Barnett S. Kramer, Charles A. Coltman, Otis W. Brawley, Leslie G. Ford

Research output: Contribution to journalArticle

Abstract

The PCPT is a chemoprevention trial of finasteride with a primary endpoint of biopsyproven presence or absence of prostate cancer. A total of 18,000 healthy men, aged 55 years and older, will be randomized. Half will receive finasteride (5 mg/day) and half will receive placebo (one matching tablet per day) for 7 years. The trial is designed to have 92% power to detect a 25% reduction in period prevalence of biopsy-proven disease using a two-sided test with α = 0.05. The trial is complicated by the known impact of finasteride on the major screening test for prostate cancer, prostate specific antigen (PSA). This paper describes the PCPT design with reference to alternatives that were considered. The chosen design depends on five critical assumptions that must be monitored closely throughout the 9-year trial.

Original languageEnglish (US)
Pages (from-to)150-163
Number of pages14
JournalControlled clinical trials
Volume16
Issue number3
DOIs
StatePublished - Jun 1995
Externally publishedYes

Keywords

  • Chemoprevention
  • biased ascertainment
  • monitoring techniques
  • prostate cancer

ASJC Scopus subject areas

  • Pharmacology

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  • Cite this

    Feigl, P., Blumenstein, B., Thompson, I., Crowley, J., Wolf, M., Kramer, B. S., Coltman, C. A., Brawley, O. W., & Ford, L. G. (1995). Design of the Prostate Cancer Prevention Trial (PCPT). Controlled clinical trials, 16(3), 150-163. https://doi.org/10.1016/0197-2456(94)00XXX-M