Abstract | OBJECTIVES: PATIENTS AND METHODS: 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 underwent blinded independent adjudication for the presence and severity of prostate cancer; PSA and testosterone levels were measured via local and central laboratory assays; and LUTS severity was assessed 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 testosterone on PSA levels and IPSS. RESULTS: Of the 999 men with clinically diagnosed hypogonadism (HG), 750 (75%) initiated TRT, contributing 23 900 person-months of exposure. The mean testosterone levels increased from 8.3 to 15.4 nmol/L in treated men, compared to only a slight increase from 9.4 to 11.3 nmol/L in untreated men. In all, 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 TRT (37.5%) compared to those not on TRT (37.0%) over the course of the study. There were no differences in PSA levels, total IPSS, or the IPSS obstructive sub-scale score by TRT status. Lower IPSS irritative sub-scale scores were reported in treated compared to untreated men. CONCLUSIONS: Results support prostate safety of TRT in newly diagnosed men with HG.
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Authors | Frans M J Debruyne, Hermann M Behre, Claus G Roehrborn, Mario Maggi, Frederick C W Wu, Fritz H Schröder, Thomas 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 |
Journal | BJU international
(BJU Int)
Vol. 119
Issue 2
Pg. 216-224
(Feb 2017)
ISSN: 1464-410X [Electronic] England |
PMID | 27409523
(Publication Type: Comparative Study, Journal Article, Multicenter Study)
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Copyright | © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd. |
Chemical References |
- Testosterone
- Prostate-Specific Antigen
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Topics |
- Disease Progression
- Hormone Replacement Therapy
(adverse effects)
- Humans
- Hypogonadism
(blood, drug therapy)
- Lower Urinary Tract Symptoms
(chemically induced, epidemiology)
- Male
- Middle Aged
- Prostate-Specific Antigen
(blood)
- Prostatic Neoplasms
(chemically induced, epidemiology)
- Registries
- Risk Assessment
- Testosterone
(adverse effects, therapeutic use)
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