{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T13:12:48Z","timestamp":1782997968754,"version":"3.54.5"},"reference-count":41,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,8,14]],"date-time":"2016-08-14T00:00:00Z","timestamp":1471132800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100000801","name":"Bayer HealthCare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000801","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      To evaluate the effects of testosterone\u2010replacement therapy (\n                      <jats:styled-content style=\"fixed-case\">TRT<\/jats:styled-content>\n                      ) on prostate health indicators in hypogonadal men, including rates of prostate cancer diagnoses, changes in prostate\u2010specific antigen (\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      ) levels and lower urinary tract symptoms (\n                      <jats:styled-content style=\"fixed-case\">LUTS<\/jats:styled-content>\n                      ) over time.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>\n                      The Registry of Hypogonadism in Men (\n                      <jats:styled-content style=\"fixed-case\">RHYME<\/jats:styled-content>\n                      ) is a multi\u2010national patient registry of treated and untreated, newly\u2010diagnosed hypogonadal men (\n                      <jats:italic>n<\/jats:italic>\n                      = 999). Follow\u2010up assessments were performed at 3\u20136, 12, 24, and 36\u00a0months. Baseline and follow\u2010up 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;\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      and testosterone levels were measured via local and central laboratory assays; and\n                      <jats:styled-content style=\"fixed-case\">LUTS<\/jats:styled-content>\n                      severity was assessed via the International Prostate Symptom Score (\n                      <jats:styled-content style=\"fixed-case\">IPSS<\/jats:styled-content>\n                      ). Incidence rates per 100\u00a0000 person\u2010years were calculated. Longitudinal mixed models were used to assess effects of testosterone on\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      levels and\n                      <jats:styled-content style=\"fixed-case\">IPSS<\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of the 999 men with clinically diagnosed hypogonadism (\n                      <jats:styled-content style=\"fixed-case\">HG<\/jats:styled-content>\n                      ), 750 (75%) initiated\n                      <jats:styled-content style=\"fixed-case\">TRT<\/jats:styled-content>\n                      , contributing 23\u00a0900 person\u2010months of exposure. The mean testosterone levels increased from 8.3 to 15.4\u00a0nmol\/L in treated men, compared to only a slight increase from 9.4 to 11.3\u00a0nmol\/L in untreated men. In all, 55 biopsies were performed for suspected prostate cancer, and 12 non\u2010cancer related biopsies were performed for other reasons. Overall, the proportion of positive biopsies was nearly identical in men on\n                      <jats:styled-content style=\"fixed-case\">TRT<\/jats:styled-content>\n                      (37.5%) compared to those not on\n                      <jats:styled-content style=\"fixed-case\">TRT<\/jats:styled-content>\n                      (37.0%) over the course of the study. There were no differences in\n                      <jats:styled-content style=\"fixed-case\">PSA<\/jats:styled-content>\n                      levels, total\n                      <jats:styled-content style=\"fixed-case\">IPSS<\/jats:styled-content>\n                      , or the\n                      <jats:styled-content style=\"fixed-case\">IPSS<\/jats:styled-content>\n                      obstructive sub\u2010scale score by\n                      <jats:styled-content style=\"fixed-case\">TRT<\/jats:styled-content>\n                      status. Lower\n                      <jats:styled-content style=\"fixed-case\">IPSS<\/jats:styled-content>\n                      irritative sub\u2010scale scores were reported in treated compared to untreated men.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Results support prostate safety of\n                      <jats:styled-content style=\"fixed-case\">TRT<\/jats:styled-content>\n                      in newly diagnosed men with\n                      <jats:styled-content style=\"fixed-case\">HG<\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.13578","type":"journal-article","created":{"date-parts":[[2016,7,13]],"date-time":"2016-07-13T13:59:26Z","timestamp":1468418366000},"page":"216-224","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":90,"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"],"prefix":"10.1111","volume":"119","author":[{"given":"Frans M.J.","family":"Debruyne","sequence":"first","affiliation":[{"name":"Andros Men's Health Institutes Arnhem The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hermann M.","family":"Behre","sequence":"additional","affiliation":[{"name":"Center for Reproductive Medicine and Andrology Martin Luther University Halle\u2010Wittenberg Halle Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus G.","family":"Roehrborn","sequence":"additional","affiliation":[{"name":"Southwestern Medical Center University of Texas Dallas TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Maggi","sequence":"additional","affiliation":[{"name":"Sexual Medicine and Andrology Unit Department of Experimental and Clinical Biomedical Sciences University of Florence Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frederick C.W.","family":"Wu","sequence":"additional","affiliation":[{"name":"University of Manchester Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fritz H.","family":"Schr\u00f6der","sequence":"additional","affiliation":[{"name":"Erasmus Medical Center Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas Hugh","family":"Jones","sequence":"additional","affiliation":[{"name":"Barnsley Hospital NHS Foundation Trust Barnsley UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hartmut","family":"Porst","sequence":"additional","affiliation":[{"name":"Private Practice of Urology\/Andrology Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geoffrey","family":"Hackett","sequence":"additional","affiliation":[{"name":"Holly Cottage Clinic Lichfield Staffordshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia A.","family":"Wheaton","sequence":"additional","affiliation":[{"name":"New England Research Institutes, Inc. 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