{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T23:36:09Z","timestamp":1759448169815,"version":"3.40.4"},"reference-count":17,"publisher":"S. Karger AG","issue":"5-6","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Urol Int"],"published-print":{"date-parts":[[2021]]},"abstract":"<jats:p>&lt;b&gt;&lt;i&gt;Background:&lt;\/i&gt;&lt;\/b&gt; Observational studies generate information on real-world therapy and complement data from prospective randomized trials. LEAN is an open-label, non-interventional, multi-centre, German cohort study on leuprorelin in routine clinical practice. &lt;b&gt;&lt;i&gt;Objectives:&lt;\/i&gt;&lt;\/b&gt; To extend knowledge on the use, effectiveness, and tolerability of HEXAL\/Sandoz leuprorelin (in this article, the term Leuprone\u00ae HEXAL\u00ae covers Leuprorelin Sandoz\u00ae as well) solid implant in patients with prostate cancer (PCa) in a real-world setting. &lt;b&gt;&lt;i&gt;Methods:&lt;\/i&gt;&lt;\/b&gt; 959 PCa patients scheduled for androgen deprivation therapy (ADT) received leuprorelin acetate implant. Metabolism, serum prostate-specific antigen (PSA), and testosterone data, if available, were collected at baseline and follow-up visits for \u226512 months. &lt;b&gt;&lt;i&gt;Results:&lt;\/i&gt;&lt;\/b&gt; Of 694 patients in the modified full analysis set, 26.4% received GnRH analogues \u22646 months before enrolment. Fifty-one percent of patients were treated for locally advanced or metastatic PCa. In 19.6% of patients, ADT was used in neoadjuvant or adjuvant settings and in 28.5% with rising PSA after definite therapy. Testosterone levels &amp;#x3c;0.5 ng\/mL were achieved in &amp;#x3e;90% of patients. Safety profile was in line with the summary of product characteristics. Therapy was well tolerated, with patient-triggered therapy discontinuation in 3.6%. &lt;b&gt;&lt;i&gt;Conclusions:&lt;\/i&gt;&lt;\/b&gt; This interim analysis confirmed previous efficacy findings for leuprorelin implant in a real-world setting. This contemporary cohort showed a shift in the use of ADT to non-metastatic PCa stages. <\/jats:p>","DOI":"10.1159\/000513073","type":"journal-article","created":{"date-parts":[[2021,3,29]],"date-time":"2021-03-29T21:05:26Z","timestamp":1617051926000},"page":"436-445","source":"Crossref","is-referenced-by-count":2,"title":["Effectiveness and Distribution of Testosterone Levels within First Year of Androgen Deprivation Therapy in a Real-World Setting: Results from the Non-Interventional German Cohort LEAN Study"],"prefix":"10.1159","volume":"105","author":[{"given":"Bernd J.","family":"Schmitz-Dr\u00e4ger","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan","family":"M\u00fchlich","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carsten","family":"Lange","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalya","family":"Benderska-S\u00f6der","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ekkehardt","family":"Bismarck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roland","family":"Starlinger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bertram","family":"Ottillinger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oliver W.","family":"Hakenberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2021,2,25]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2020.06.011"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.2147\/OTT.S117176"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-013-0010-y"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdq443"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.49.6489"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1503747"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01037-5"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1704174"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1702900"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1201546"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2008.08183.x"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2012.11190.x"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1016\/j.clgc.2017.10.025"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.58.2973"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2007.05.129"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1016\/j.clgc.2013.01.002"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1038\/pcan.2008.52"}],"container-title":["Urologia Internationalis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/513073","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/513073","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T16:10:24Z","timestamp":1745424624000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000513073"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021]]},"references-count":17,"journal-issue":{"issue":"5-6","published-online":{"date-parts":[[2021,4,30]]},"published-print":{"date-parts":[[2021,5,3]]}},"URL":"https:\/\/doi.org\/10.1159\/000513073","archive":["Portico"],"relation":{},"ISSN":["0042-1138","1423-0399"],"issn-type":[{"type":"print","value":"0042-1138"},{"type":"electronic","value":"1423-0399"}],"subject":[],"published":{"date-parts":[[2021]]}}}