{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T07:17:32Z","timestamp":1781939852522,"version":"3.54.5"},"reference-count":21,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,4,16]],"date-time":"2016-04-16T00:00:00Z","timestamp":1460764800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Tolmar, Inc"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"published-print":{"date-parts":[[2017,2]]},"abstract":"\n Objective<\/jats:title>\n \n To determine whether luteinising hormone\u2010releasing hormone (\n LHRH<\/jats:styled-content>\n ) agonist,\n ATRIGEL<\/jats:styled-content>\n \u00ae<\/jats:sup>\n polymer\u2010delivered, subcutaneous, leuprolide acetate (\n ADSC<\/jats:styled-content>\n \u2010\n LA<\/jats:styled-content>\n ), formulations suppressed serum testosterone to concentrations of \u226420\u00a0ng\/\n dL<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Patients and Methods<\/jats:title>\n \n Data from four open\u2010label, fixed\u2010dose studies were evaluated. Male patients aged 40\u201386\u00a0years with advanced prostatic adenocarcinoma, whom had not undergone prior androgen\u2010deprivation therapy (\n ADT<\/jats:styled-content>\n ), were treated with a depot formulation of\n ADSC<\/jats:styled-content>\n \u2010\n LA<\/jats:styled-content>\n : 7.5\u00a0mg (1\u2010month, 120 patients), 22.5\u00a0mg (3\u2010month, 117 patients), 30\u00a0mg (4\u2010month, 90 patients), or 45\u00a0mg (6\u2010month, 111 patients). Serum testosterone was sampled at screening, baseline, 2, 4, 8\u00a0h after dosing, 1, 2, 3, and 7\u00a0days, and every week until the next dose, at which time, the sampling schedule repeated until the end of study (24\u00a0weeks for 1\u2010 and 3\u2010month formulations, 32\u00a0weeks for 4\u2010month, and 48\u00a0weeks for the 6\u2010month). The primary analyses were mean serum testosterone concentrations and proportion of patients who achieved concentrations of \u226420\u00a0ng\/\n dL<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The mean (\n SE<\/jats:styled-content>\n ) serum testosterone concentrations at the end of study were consistently \u226420\u00a0ng\/\n dL<\/jats:styled-content>\n in each study, at 6.1 (0.4), 10.1 (0.7), 12.4 (0.8), and 12.6 (2.1)\u00a0ng\/\n dL<\/jats:styled-content>\n for the 1\u2010, 3\u2010, 4\u2010, and 6\u2010month formulations, respectively. A high proportion of patients (94%, 90%, 92%, 96% for the 1\u2010, 3\u2010, 4\u2010, and 6\u2010month formulations, respectively) achieved testosterone concentrations of \u226420\u00a0ng\/\n dL<\/jats:styled-content>\n within 6\u00a0weeks, and 90\u201397% of patients in all studies maintained concentrations of \u226420\u00a0ng\/\n dL<\/jats:styled-content>\n from weeks 6\u201324.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Recent studies have shown improved outcomes in patients with prostate cancer who consistently attained a more rigorous level of testosterone suppression (\u226420\u00a0ng\/\n dL<\/jats:styled-content>\n ) with\n ADT<\/jats:styled-content>\n than the historical standard (\u226450\u00a0ng\/\n dL<\/jats:styled-content>\n ). All doses of\n ADSC<\/jats:styled-content>\n \u2010\n LA<\/jats:styled-content>\n rapidly achieved and maintained mean serum testosterone to the more rigorous target concentration of \u226420\u00a0ng\/\n dL<\/jats:styled-content>\n . These data suggest that\n ADSC<\/jats:styled-content>\n \u2010\n LA<\/jats:styled-content>\n delivers equivalent testosterone suppression as achieved by surgical castration.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/bju.13482","type":"journal-article","created":{"date-parts":[[2016,3,19]],"date-time":"2016-03-19T03:08:09Z","timestamp":1458356889000},"page":"239-244","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Polymer\u2010delivered subcutaneous leuprolide acetate formulations achieve and maintain castrate concentrations of testosterone in four open\u2010label studies in patients with advanced prostate cancer"],"prefix":"10.1111","volume":"119","author":[{"given":"Neal D.","family":"Shore","sequence":"first","affiliation":[{"name":"Carolina Urologic Research Center Myrtle Beach SC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franklin","family":"Chu","sequence":"additional","affiliation":[{"name":"San Bernardino Urological Associates San Bernardino CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judd","family":"Moul","sequence":"additional","affiliation":[{"name":"Division of Urology Department of Surgery and Duke Cancer Institute Duke University Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Saltzstein","sequence":"additional","affiliation":[{"name":"Urology San Antonio San Antonio TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raoul","family":"Concepcion","sequence":"additional","affiliation":[{"name":"Urology Associates, P.C. Nashville TN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John\u00a0A.","family":"McLane","sequence":"additional","affiliation":[{"name":"Tolmar, Inc. Fort Collins CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Atkinson","sequence":"additional","affiliation":[{"name":"Tolmar Pharmaceuticals, Inc. Lincolnshire IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Yang","sequence":"additional","affiliation":[{"name":"Tolmar Pharmaceuticals, Inc. Lincolnshire IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. 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