Dutasteride reduces risk of low grade prostate cancer

January 01, 0001

Dutasteride reduces risk of low grade prostate cancer

These authors from multiple countries conducted 4-year randomized controlled trial 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. They 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.

They found: "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% over the 4-year study period. Overall, in years 1 through 4, among the 6706 men who underwent a needle biopsy, there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group. During years 3 and 4, there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group, as compared with only 1 in the placebo group. Dutasteride therapy, as compared with placebo, resulted in a reduction in the rate of acute urinary retention (1.6% vs. 6.7). The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia, except that in our study, as compared with previous studies, the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group (0.7% vs. 0.4%)."

The authors concluded: "Over the course of the 4-year study period, dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia."

The difference between groups in prostate cancer risk was for tumors with Gleason score less than 7.

For the full abstract, click here.

N Engl J Med 362(13):1192-1202, 1 April 2010
© 2010 to the Massachusetts Medical Society
Effect of Dutasteride on the Risk of Prostate Cancer. Gerald L. Andriole, David G. Bostwick, Otis W. Brawley, et al for the REDUCE Study Group. Correspondence to Dr. Andriole: [email protected]

Category: Y. Male Genital System, Breast. Keywords: dutasteride, prostate cancer, prostate specific antigen, PSA, prostate cancer, Gleason score, urinary retention, heart failure, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 13 April 2010

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