6/29/23, 1:37 AM PCPT Pathway Feedback Search Clinical Topics Home Studies PCPT PCPT DiseaseProstate cancer Trial question What is the role of finasteride on the development of prostate cancer? Study design Multi-center Double blinded RCT Population 18882 male patients Inclusion criteria: men 55 years with a normal DRE and PSA level 3.0 ng/mL Key exclusion criteria: PSA level > 3.0 ng/mL, previous prostate cancer, early termination of the study, or declined biopsy Interventions N=9423 finasteride (5 mg/day for 7 years) N=9459 placebo (matching placebo for 7 years) Primary outcome Prevalence of prostate cancer over the 7-year period 24.4 % 24.4 18.3 % 18.4 12.2 % Significant decrease 6.1 % NNT = 17 0.0 % Finasteride Placebo https://web.pathway.md/studies/recS6onWOWpiawLJf 1/2 6/29/23, 1:37 AM PCPT Pathway Significant decrease in the prevalence of prostate cancer over the 7-year period (18.4% vs. 24.4%; RR 0.75, 95% CI 0.69 to 0.81) Secondary outcomes Significant increase in tumors of Gleason grade 7, 8, 9, or 10 (6.4% vs. 5.1%; RR 1.27, 95% CI 1.07 to 1.5) Safety outcomes No significant difference in number of deaths (5 vs. 5). Significant difference in sexual side-effects more common in finasteride group (p < 0.001 for all comparisons) and urinary symptoms more common in placebo group (p < 0.001 for all comparisons). Conclusion In men 55 years with a normal DRE and PSA level 3.0 ng/mL, finasteride was superior to placebo with respect to the prevalence of prostate cancer over the 7-year period. Reference Thompson IM, Goodman PJ, Tangen CM et al. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 Jul 17;349(3):215-24. Open reference URL https://web.pathway.md/studies/recS6onWOWpiawLJf 2/2