Abstract

To evaluate whether the use of dutasteride is associated with a lower risk of transrectal prostate biopsy-associated urinary tract infection (TPBA-UTI) among men in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study. Retrospective analysis of 6045 men undergoing 2-year repeat prostate biopsy in REDUCE. Participants were randomized to receive dutasteride 0.5mg or placebo daily. TPBA-UTI was defined as the presence of urinary symptoms and the prescription of antibiotics by the treating physician within 30days after biopsy. Severe TPBA-UTI was defined as TPBA-UTI requiring hospitalization. Comparison of TPBA-UTI between treatment arms was done using Chi-square test and logistic regression adjusting for participant characteristics. Of the subjects included in the study, 3067 (50.7%) were randomized to the placebo arm and 2978 (49.3%) to the dutasteride arm. A total 51 (0.8%) men had TPBA-UTI, including 38 (1.2%) in the placebo arm and 13 (0.4%) in the dutasteride arm (univariable relative risk [RR]=0.35, P=0.001; multivariable odds ratio [OR]=0.34, P=0.003). The number needed to treat (NNT) to prevent one TPBA-UTI was 125 subjects. Of these, 14 (28%) had severe TPBA-UTI, including 12 (0.4%) in the placebo arm and only 2 (0.07%) in the dutasteride arm (univariable RR=0.17, P=0.021; multivariable OR=0.17, P=0.031). The NNT to prevent one severe TPBA-UTI was 309 subjects. Among men undergoing a 2-year repeat prostate biopsy, the use of dutasteride for 2years was associated with a reduced the risk of overall and severe TBPA-UTI. CLINICALTRIALS. NCT00056407.

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