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1: Control Clin Trials. 1995 Jun;16(3):150-63.Click here to read Links

Design of the Prostate Cancer Prevention Trial (PCPT).

Feigl P, Blumenstein B, Thompson I, Crowley J, Wolf M, Kramer BS, Coltman CA Jr, Brawley OW, Ford LG.

Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington 90104-2092, USA.

The PCPT is a chemoprevention trial of finasteride with a primary endpoint of biopsy-proven 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 alpha = 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.

PMID: 7540965 [PubMed - indexed for MEDLINE]

Patient Drug Information

  • Finasteride (Proscar® , Propecia® )

    Finasteride (Proscar) is used alone or in combination with another medication (doxazosin [Cardura]) to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland). Finasteride improves symptoms of BPH suc...

  • Source: AHFS Consumer Medication Information