The influence of finasteride on the development of prostate cancer

Ian M. Thompson, Phyllis J. Goodman, Catherine M. Tangen, M. Scott Lucia, Gary J. Miller, Leslie G. Ford, Michael M. Lieber, R. Duane Cespedes, James N. Atkins, Scott M. Lippman, Susie M. Carlin, Anne Ryan, Connie M. Szczepanek, John J. Crowley, Charles A. Coltman

Research output: Contribution to journalArticle

2095 Citations (Scopus)

Abstract

BACKGROUND: Androgens are involved in the development of prostate cancer. Finasteride, an inhibitor of 5α-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce the risk of prostate cancer. METHODS: In the Prostate Cancer Prevention Trial, we randomly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower to treatment with finasteride (5 mg per day) or placebo for seven years. Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal. It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study. The primary end point was the prevalence of prostate cancer during the seven years of the study. RESULTS: Prostate cancer was detected in 803 of the 4368 men in the finasteride group who had data for the final analysis (18.4 percent) and 1147 of the 4692 men in the placebo group who had such data (24.4 percent), for a 24.8 percent reduction in prevalence over the seven-year period (95 percent confidence interval, 18.6 to 30.6 percent; P<0.001). Tumors of Gleason grade 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 4368 men included in the final analysis) than in the placebo group (237 of 1068 tumors [22.2 percent], PΑ0.001 for the comparison between groups; or 5.1 percent of the 4692 men included in the final analysis, P=0.005 for the comparison between groups). Sexual side effects were more common in finasteride-treated men, whereas urinary symptoms were more common in men receiving placebo. CONCLUSIONS: Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer.

Original languageEnglish (US)
Pages (from-to)215-224
Number of pages10
JournalNew England Journal of Medicine
Volume349
Issue number3
DOIs
StatePublished - Jul 17 2003

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Finasteride
Prostatic Neoplasms
Placebos
Digital Rectal Examination
Prostate-Specific Antigen
Androgens
Prostate
Biopsy
Neoplasms
Dihydrotestosterone
Testosterone
Oxidoreductases
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Thompson, I. M., Goodman, P. J., Tangen, C. M., Lucia, M. S., Miller, G. J., Ford, L. G., ... Coltman, C. A. (2003). The influence of finasteride on the development of prostate cancer. New England Journal of Medicine, 349(3), 215-224. https://doi.org/10.1056/NEJMoa030660

The influence of finasteride on the development of prostate cancer. / Thompson, Ian M.; Goodman, Phyllis J.; Tangen, Catherine M.; Lucia, M. Scott; Miller, Gary J.; Ford, Leslie G.; Lieber, Michael M.; Cespedes, R. Duane; Atkins, James N.; Lippman, Scott M.; Carlin, Susie M.; Ryan, Anne; Szczepanek, Connie M.; Crowley, John J.; Coltman, Charles A.

In: New England Journal of Medicine, Vol. 349, No. 3, 17.07.2003, p. 215-224.

Research output: Contribution to journalArticle

Thompson, IM, Goodman, PJ, Tangen, CM, Lucia, MS, Miller, GJ, Ford, LG, Lieber, MM, Cespedes, RD, Atkins, JN, Lippman, SM, Carlin, SM, Ryan, A, Szczepanek, CM, Crowley, JJ & Coltman, CA 2003, 'The influence of finasteride on the development of prostate cancer', New England Journal of Medicine, vol. 349, no. 3, pp. 215-224. https://doi.org/10.1056/NEJMoa030660
Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG et al. The influence of finasteride on the development of prostate cancer. New England Journal of Medicine. 2003 Jul 17;349(3):215-224. https://doi.org/10.1056/NEJMoa030660
Thompson, Ian M. ; Goodman, Phyllis J. ; Tangen, Catherine M. ; Lucia, M. Scott ; Miller, Gary J. ; Ford, Leslie G. ; Lieber, Michael M. ; Cespedes, R. Duane ; Atkins, James N. ; Lippman, Scott M. ; Carlin, Susie M. ; Ryan, Anne ; Szczepanek, Connie M. ; Crowley, John J. ; Coltman, Charles A. / The influence of finasteride on the development of prostate cancer. In: New England Journal of Medicine. 2003 ; Vol. 349, No. 3. pp. 215-224.
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abstract = "BACKGROUND: Androgens are involved in the development of prostate cancer. Finasteride, an inhibitor of 5α-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce the risk of prostate cancer. METHODS: In the Prostate Cancer Prevention Trial, we randomly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower to treatment with finasteride (5 mg per day) or placebo for seven years. Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal. It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study. The primary end point was the prevalence of prostate cancer during the seven years of the study. RESULTS: Prostate cancer was detected in 803 of the 4368 men in the finasteride group who had data for the final analysis (18.4 percent) and 1147 of the 4692 men in the placebo group who had such data (24.4 percent), for a 24.8 percent reduction in prevalence over the seven-year period (95 percent confidence interval, 18.6 to 30.6 percent; P<0.001). Tumors of Gleason grade 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 4368 men included in the final analysis) than in the placebo group (237 of 1068 tumors [22.2 percent], PΑ0.001 for the comparison between groups; or 5.1 percent of the 4692 men included in the final analysis, P=0.005 for the comparison between groups). Sexual side effects were more common in finasteride-treated men, whereas urinary symptoms were more common in men receiving placebo. CONCLUSIONS: Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer.",
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AU - Thompson, Ian M.

AU - Goodman, Phyllis J.

AU - Tangen, Catherine M.

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AU - Miller, Gary J.

AU - Ford, Leslie G.

AU - Lieber, Michael M.

AU - Cespedes, R. Duane

AU - Atkins, James N.

AU - Lippman, Scott M.

AU - Carlin, Susie M.

AU - Ryan, Anne

AU - Szczepanek, Connie M.

AU - Crowley, John J.

AU - Coltman, Charles A.

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N2 - BACKGROUND: Androgens are involved in the development of prostate cancer. Finasteride, an inhibitor of 5α-reductase, inhibits the conversion of testosterone to dihydrotestosterone, the primary androgen in the prostate, and may reduce the risk of prostate cancer. METHODS: In the Prostate Cancer Prevention Trial, we randomly assigned 18,882 men 55 years of age or older with a normal digital rectal examination and a prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower to treatment with finasteride (5 mg per day) or placebo for seven years. Prostate biopsy was recommended if the annual PSA level, adjusted for the effect of finasteride, exceeded 4.0 ng per milliliter or if the digital rectal examination was abnormal. It was anticipated that 60 percent of participants would have prostate cancer diagnosed during the study or would undergo biopsy at the end of the study. The primary end point was the prevalence of prostate cancer during the seven years of the study. RESULTS: Prostate cancer was detected in 803 of the 4368 men in the finasteride group who had data for the final analysis (18.4 percent) and 1147 of the 4692 men in the placebo group who had such data (24.4 percent), for a 24.8 percent reduction in prevalence over the seven-year period (95 percent confidence interval, 18.6 to 30.6 percent; P<0.001). Tumors of Gleason grade 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 4368 men included in the final analysis) than in the placebo group (237 of 1068 tumors [22.2 percent], PΑ0.001 for the comparison between groups; or 5.1 percent of the 4692 men included in the final analysis, P=0.005 for the comparison between groups). Sexual side effects were more common in finasteride-treated men, whereas urinary symptoms were more common in men receiving placebo. CONCLUSIONS: Finasteride prevents or delays the appearance of prostate cancer, but this possible benefit and a reduced risk of urinary problems must be weighed against sexual side effects and the increased risk of high-grade prostate cancer.

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