To evaluate the effects of testosterone replacement therapy (TRT) on prostate health indicators in hypogonadal men, including rates of prostate cancer diagnoses, changes in PSA levels and lower urinary tract symptoms (LUTS) over time.
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The Registry of Hypogonadism in Men (RHYME) is a multi-national patient registry of treated and untreated, newly-diagnosed hypogonadal men (n=999). Follow-up assessments were performed at 3-6, 12, 24, and 36 months. Baseline and follow-up data collection included medical history, physical examination, blood sampling, and patient questionnaires. Prostate biopsies were subjected to blinded, independent adjudication for presence and severity of prostate cancer (PCa), Prostate Specific Antigen (PSA), and Testosterone (T) levels measured via local and central laboratory assays, and LUTS severity via the International Prostate Symptom Score (IPSS). Incidence rates per 100,000 person-years were calculated. Longitudinal mixed models were used to assess effects of T on PSA and IPSS.
Of 999 patients with clinically-diagnosed HG, 750 (75%) initiated TRT, contributing 23,900 person-months of exposure. Mean T levels increased from 8.3 to 15.4 nmol/L in treated men, compared to only a slight increase from 9.4 nmol/L to 11.3 nmol/L in untreated men. Fifty-five (55) biopsies were performed for suspected prostate cancer, and 12 non-cancer related biopsies were performed for other reasons. Overall, the proportion of positive biopsies was nearly identical in men on T (37.5%) compared to those not on T (37.0%) over the course of the study. No differences were observed in PSA levels, total IPSS score, or IPSS obstructive sub-scale score by testosterone treatment status. Lower IPSS irritative sub-scale scores were reported in treated men compared to untreated men.
Results support prostate safety of TRT in newly diagnosed men with hypogonadism (HG). This article is protected by copyright. All rights reserved.
BJU international. 2016 Jul 13 [Epub ahead of print]
Frans M J Debruyne, Hermann M Behre, Claus G Roehrborn, Mario Maggi, Frederick C W Wu, Fritz H Schröder, T Hugh Jones, Hartmut Porst, Geoffrey Hackett, Olivia A Wheaton, Antonio Martin-Morales, Eric Meuleman, Glenn R Cunningham, Hozefa A Divan, Raymond C Rosen, RHYME Investigators
Andros Men's Health Institute, The Netherlands., Center for Reproductive Medicine and Andrology, Martin Luther University Halle-Wittenberg, Halle, Germany., UT Southwestern Medical Center, USA., University of Florence, Italy., University of Manchester, UK., Erasmus Medical Center, The Netherlands., Barnsley Hospital NHS FT, UK., Private Practice of Urology/Andrology: Dr. Porst, Germany., Holly Cottage Clinic, UK., New England Research Institutes, Inc., USA., Carlos Haya University Hospital, Spain., VU Medical Center, The Netherlands., Baylor College of Medicine, St. Luke's Episcopal Hospital, USA., New England Research Institutes, Inc., USA., New England Research Institutes, Inc., USA.