title: Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: prostate health outcomes in the Registry of Hypogonadism in Men.
abstract: OBJECTIVE
  To evaluate the effects of testosterone-replacement therapy (TRT) on prostate health indicators in hypogonadal men, including rates of prostate cancer diagnoses, changes in prostate-specific antigen (PSA) levels and lower urinary tract symptoms (LUTS) over time.
  
  
  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.
authors.affiliation: Andros Men's Health Institutes, Arnhem, The Netherlands.
authors.forename: Frans M J
authors.initials: FM
authors.lastname: Debruyne
authors.affiliation: Center for Reproductive Medicine and Andrology, Martin Luther University Halle-Wittenberg, Halle, Germany.
authors.forename: Hermann M
authors.initials: HM
authors.lastname: Behre
authors.affiliation: Southwestern Medical Center, University of Texas, Dallas, TX, USA.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.affiliation: Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Maggi
authors.affiliation: University of Manchester, Manchester, UK.
authors.forename: Frederick C W
authors.initials: FC
authors.lastname: Wu
authors.affiliation: Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Fritz H
authors.initials: FH
authors.lastname: Schröder
authors.affiliation: Barnsley Hospital NHS Foundation Trust, Barnsley, UK.
authors.forename: Thomas Hugh
authors.initials: TH
authors.lastname: Jones
authors.affiliation: Private Practice of Urology/Andrology, Hamburg, Germany.
authors.forename: Hartmut
authors.initials: H
authors.lastname: Porst
authors.affiliation: Holly Cottage Clinic, Lichfield, Staffordshire, UK.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Hackett
authors.affiliation: New England Research Institutes, Inc., Watertown, MA, USA.
authors.forename: Olivia A
authors.initials: OA
authors.lastname: Wheaton
authors.affiliation: Carlos Haya University Hospital, Málaga, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Martin-Morales
authors.affiliation: VU Medical Center, Amsterdam, The Netherlands.
authors.forename: Eric
authors.initials: E
authors.lastname: Meuleman
authors.affiliation: Baylor College of Medicine, St. Luke's Episcopal Hospital, Houston, TX, USA.
authors.forename: Glenn R
authors.initials: GR
authors.lastname: Cunningham
authors.affiliation: New England Research Institutes, Inc., Watertown, MA, USA.
authors.forename: Hozefa A
authors.initials: HA
authors.lastname: Divan
authors.affiliation: New England Research Institutes, Inc., Watertown, MA, USA.
authors.forename: Raymond C
authors.initials: RC
authors.lastname: Rosen
mesh_terms: D018450:Disease Progression; D020249:Hormone Replacement Therapy / Q000009:adverse effects; D006801:Humans; D007006:Hypogonadism / Q000097:blood / Q000188:drug therapy*; D059411:Lower Urinary Tract Symptoms / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000139:chemically induced* / Q000453:epidemiology; D012042:Registries; D018570:Risk Assessment; D013739:Testosterone / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D013739:Testosterone; D017430:Prostate-Specific Antigen
keywords: #PCSM; #ProstateCancer; benign prostatic hyperplasia; disease registry; hypogonadism; testosterone