Objectives: 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.
Methods: Retrospective analysis of 6045 men undergoing 2-year repeat prostate biopsy in REDUCE. Participants were randomized to receive dutasteride 0.5 mg or placebo daily. TPBA-UTI was defined as the presence of urinary symptoms and the prescription of antibiotics by the treating physician within 30 days 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.
Results: 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.
Conclusion: Among men undergoing a 2-year repeat prostate biopsy, the use of dutasteride for 2 years was associated with a reduced the risk of overall and severe TBPA-UTI. CLINICALTRIALS.
Gov identifier: NCT00056407.
Keywords: 5-Alpha-reductase inhibitors; Biopsy; Double-blind method; Dutasteride; Humans; Male; Middle aged; Urinary tract infection.