The Influence of Finasteride on the Development of Prostate Cancer
Ian M. Thompson, M.D., Phyllis J. Goodman, M.S., Catherine M. Tangen, Dr.P.H., M. Scott Lucia, M.D., Gary J. Miller, M.D., Ph.D., Leslie G. Ford, M.D., Michael M. Lieber, M.D., R. Duane Cespedes, M.D., James N. Atkins, M.D., Scott M. Lippman, M.D., Susie M. Carlin, B.A., Anne Ryan, R.N., Connie M. Szczepanek, R.N., B.S.N., John J. Crowley, Ph.D., and Charles A. Coltman, Jr., M.D.
Background Androgens are involved in the development of prostatecancer. Finasteride, an inhibitor of 5-reductase, inhibits theconversion of testosterone to dihydrotestosterone, the primaryandrogen in the prostate, and may reduce the risk of prostatecancer.
Methods In the Prostate Cancer Prevention Trial, we randomlyassigned 18,882 men 55 years of age or older with a normal digitalrectal examination and a prostate-specific antigen (PSA) levelof 3.0 ng per milliliter or lower to treatment with finasteride(5 mg per day) or placebo for seven years. Prostate biopsy wasrecommended if the annual PSA level, adjusted for the effectof finasteride, exceeded 4.0 ng per milliliter or if the digitalrectal examination was abnormal. It was anticipated that 60percent of participants would have prostate cancer diagnosedduring the study or would undergo biopsy at the end of the study.The primary end point was the prevalence of prostate cancerduring the seven years of the study.
Results Prostate cancer was detected in 803 of the 4368 menin the finasteride group who had data for the final analysis(18.4 percent) and 1147 of the 4692 men in the placebo groupwho had such data (24.4 percent), for a 24.8 percent reductionin prevalence over the seven-year period (95 percent confidenceinterval, 18.6 to 30.6 percent; P<0.001). Tumors of Gleasongrade 7, 8, 9, or 10 were more common in the finasteride group(280 of 757 tumors [37.0 percent], or 6.4 percent of the 4368men included in the final analysis) than in the placebo group(237 of 1068 tumors [22.2 percent], P<0.001 for the comparisonbetween groups; or 5.1 percent of the 4692 men included in thefinal analysis, P=0.005 for the comparison between groups).Sexual side effects were more common in finasteride-treatedmen, whereas urinary symptoms were more common in men receivingplacebo.
Conclusions Finasteride prevents or delays the appearance ofprostate cancer, but this possible benefit and a reduced riskof urinary problems must be weighed against sexual side effectsand the increased risk of high-grade prostate cancer.
Source Information
From the University of Texas Health Science Center, San Antonio (I.M.T.); the Southwest Oncology Group Statistical Center, Seattle (P.J.G., C.M.T., S.M.C., J.J.C.); the University of Colorado, Denver (M.S.L., G.J.M.); the National Cancer Institute, Bethesda, Md. (L.G.F., A.R.); the Mayo Clinic, Rochester, Minn. (M.M.L.); the Wilford Hall U.S. Air Force Medical Center, San Antonio, Tex. (R.D.C.); the Southeastern Medical Oncology Center, Goldsboro, N.C. (J.N.A.); the M.D. Anderson Cancer Center, Houston (S.M.L.); the Grand Rapids Community Clinical Oncology Program, Grand Rapids, Mich. (C.M.S.); and the Southwest Oncology Group Operations Office, San Antonio, Tex. (C.A.C.). This article was published at www.nejm.org on June 24, 2003.
Address reprint requests to the Southwest Oncology Group (SWOG-9217), Operations Office, 14980 Omicron Dr., San Antonio, TX 78245-3217.
Prevention of Prostate Cancer with Finasteride
Rubin M. A., Kantoff P. W., Roehrborn C. G., Burke H. B., Schwartz D. T., Ross R. K., Skinner E., Cote R. J., Lee S. C., Ellis R. J., Barzell W. E., Thompson I. M. Jr., Goodman P. J., Coltman C. A. Jr.
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N Engl J Med 2003;
349:1569-1572, Oct 16, 2003.
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[Abstract][Full Text]
Lucia, M. S., Epstein, J. I., Goodman, P. J., Darke, A. K., Reuter, V. E., Civantos, F., Tangen, C. M., Parnes, H. L., Lippman, S. M., La Rosa, F. G., Kattan, M. W., Crawford, E. D., Ford, L. G., Coltman, C. A. Jr, Thompson, I. M.
(2007). Finasteride and High-Grade Prostate Cancer in the Prostate Cancer Prevention Trial. JNCI J Natl Cancer Inst
99: 1375-1383
[Abstract][Full Text]
Cohen, Y. C., Liu, K. S., Heyden, N. L., Carides, A. D., Anderson, K. M., Daifotis, A. G., Gann, P. H.
(2007). Detection Bias Due to the Effect of Finasteride on Prostate Volume: A Modeling Approach for Analysis of the Prostate Cancer Prevention Trial. JNCI J Natl Cancer Inst
99: 1366-1374
[Abstract][Full Text]
Andriole, G. L., Humphrey, P. A., Serfling, R. J., Grubb, R. L.
(2007). High-Grade Prostate Cancer in the Prostate Cancer Prevention Trial: Fact or Artifact?. JNCI J Natl Cancer Inst
99: 1355-1356
[Full Text]
-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce the risk of prostate cancer. 
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