Stable intraprostatic dihydrotestosterone in healthy medically castrate men treated with exogenous testosterone

Abstract

Context: Concern exists that T replacement therapy (TRT) might increase the risk of prostate disease. There are limited data regarding the impact of TRT on prostate androgen concentrations. Objective: Determine the dose-dependent effects of exogenous T administration on intraprostatic androgen concentrations. Design: Twelve-week, double-blinded, randomized, placebo-controlled trial. Setting: Academic medical center. Participants: Sixty-two healthy eugonadal men, aged 25-55 years. Interventions: Subjects were randomly assigned to receive injections of acyline, a GnRH antagonist (used to achieve medical castration), every 2 weeks plus transdermal T gel (1.25 g, 2.5 g, 5.0 g, 10 g, or 15 g daily), or placebo injections and transdermal gel for 12 weeks. Main Outcomes: Serum T and dihydrotestosterone (DHT) were measured at baseline and every 2 weeks during treatment. Intraprostatic T and DHT concentrations were assessed from tissue obtained through ultrasound-guided prostate needle biopsies at week 12. Androgens were quantified by liquid chromatography-tandem mass spectrometry. Results: 51 men completed the study and were included in the analysis. There were no significant adverse events. Exogenous T resulted in a dose-dependent increase in serum T and DHT concentrations (190-770 and 60-180 ng/dL, respectively). Although intraprostatic T differed among dose groups (P