Published in
Massachusetts Medical Society, New England Journal of Medicine, 13(362), p. 1192-1202
Elsevier, Year Book of Medicine, (2011), p. 146-147
DOI: 10.1016/s0084-3873(11)00202-1
Elsevier, Year Book of Urology, (2010), p. 70-71
DOI: 10.1016/s0084-4071(10)79501-4
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- Massachusetts Medical Society
- Elsevier
- Elsevier
- Elsevier
- [discovery.ucl.ac.uk]
- [hdl.handle.net]
- [hdl.handle.net]
- [hal.archives-ouvertes.fr]
- [richardhaddadurology.com.au] | PDF
- [www.researchgate.net] | PDF
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Effect of dutasteride on the risk of prostate cancer
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Abstract
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, parallel-group study, we compared dutasteride, at a dose of 0.5 mg daily, with placebo. Men were 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