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Table 14. Randomized Controlled Trials (RCTs) Examining the Efficacy of 5-Alpha-Reductase Inhibitors in Prostate Cancer Chemopreventiona

 PCPT (Finasteride) [15] REDUCE (Dutasteride) [16] 
Duration of RCT 7 y4 y
No. of participants included in analysis 9,0608,231
– % with FH of prostate cancer16.7%13.0%
– % African American3.3%2.3%
Benefits
– Absolute risk reduction in incidence6%5.1%
– Relative risk reduction in incidence24.8%22.8%
– Prostate cancer mortalityNo differenceNo difference
Harms
– Incidence of high-grade prostate cancerb6.4% (finasteride) vs. 5.1% (placebo)0.9% (dutasteride) vs. 0.6% (placebo)
– Side effectsDecreased volume ejaculateDecreased volume ejaculate
Decreased libidoDecreased libido
Erectile dysfunctionErectile dysfunction
GynecomastiaGynecomastia

FH = family history; PCPT = Prostate Cancer Prevention Trial; REDUCE = Reduction by Dutasteride of Prostate Cancer Events trial.
aThis table summarizes the first two RCTs of finasteride and dutasteride in prostate cancer chemoprevention.
bHigh-grade prostate cancer is defined as a Gleason score ≥7 in PCPT and a Gleason score ≥8 in REDUCE.

References

  1. Thompson IM, Goodman PJ, Tangen CM, et al.: The influence of finasteride on the development of prostate cancer. N Engl J Med 349 (3): 215-24, 2003.  [PUBMED Abstract]

  2. Andriole GL, Bostwick DG, Brawley OW, et al.: Effect of dutasteride on the risk of prostate cancer. N Engl J Med 362 (13): 1192-202, 2010.  [PUBMED Abstract]