PCPT
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
18.4%
24.4%
24.4 %
18.3 %
12.2 %
6.1 %
0.0 %
Finasteride
Placebo
Significant
decrease ▼
NNT = 16
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.
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