Journal
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Volume 101, Issue 7, Pages 2937-2944Publisher
ENDOCRINE SOC
DOI: 10.1210/jc.2016-1483
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Funding
- National Institute of Aging, National Institutes of Health (NIH) [RO1AG037603]
- NIH [5T32DK007247-37]
- Robert B. McMillen Professorship
- University of Washington Nutrition Obesity Research Center [P30 DK035816]
- American Heart Association Clinical Research Program
- Eunice Kennedy Shriver National Institute of Child Health and Development Grant [6K12 HD053984]
- VA Advanced Fellowship in Geriatrics
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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 = .01), intraprostatic DHT was comparable regardless of T dose (P = .11) and was 10- to 20-fold greater than intraprostatic T. Conclusions: In healthy, medically castrate men receiving exogenous T, the total intraprostatic androgen concentration (predominantly DHT) remained stable across serum T concentrations within the physiological range. These findings further our knowledge of the relationship between serum and intraprostatic androgens and suggest that physiological serum T achieved by TRT is unlikely to alter the prostate hormonal milieu.
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