Effect of dutasteride on the risk of prostate cancer

Gerald L. Andriole, David G. Bostwick, Otis W. Brawley, Leonard G. Gomella, Michael Marberger, Francesco Montorsi, Curtis A. Pettaway, Teuvo L. Tammela, Claudio Teloken, Donald J. Tindall, Matthew C. Somerville, Timothy H. Wilson, Ivy L. Fowler, Roger S. Rittmaster

Research output: Contribution to journalArticlepeer-review


Background: We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Methods: In this 4-year, multicenter, randomized, double-blind, placebo-controlled, parallelgroup study, we compared dutasteride, at a dose of 0.5 mg daily, with placebo. Menwere eligible for inclusion in the study if they were 50 to 75 years of age, had a prostate-specific antigen (PSA) level of 2.5 to 10.0 ng per milliliter, and had had one negative prostate biopsy (6 to 12 cores) within 6 months before enrollment. Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years. Results: Among 6729 men who underwent a biopsy or prostate surgery, cancer was detected in 659 of the 3305 men in the dutasteride group, as compared with 858 of the 3424 men in the placebo group, representing a relative risk reduction with dutasteride of 22.8% (95% confidence interval, 15.2 to 29.8) over the 4-year study period (P

Original languageEnglish
Pages (from-to)1192-1202
Number of pages11
JournalNew England Journal of Medicine
Issue number13
Publication statusPublished - Apr 1 2010

ASJC Scopus subject areas

  • Medicine(all)


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