PCPT — The Prostate Cancer Prevention Trial: The Influence of Finasteride on the Development of Prostate Cancer

Phase 3 · 2003 · Prostate Cancer

Design

Randomized, double-blind, placebo-controlled phase 3 chemoprevention trial of finasteride 5 mg daily versus placebo for 7 years with end-of-study prostate biopsy.

Population

Men 55 years or older with a normal digital rectal examination and PSA of 3.0 ng/mL or lower.

Primary Endpoint

Prevalence of prostate cancer during the 7-year study period

Key Result

Prostate cancer was detected in 18.4% of the finasteride group versus 24.4% of the placebo group, a 24.8% relative risk reduction (P<0.001), though high-grade (Gleason 7-10) tumors were more common with finasteride (6.4% vs 5.1%).

Guideline Impact

Informed shared decision-making guidance on 5-alpha-reductase inhibitors for prostate cancer risk reduction