{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T15:14:03Z","timestamp":1778944443330,"version":"3.51.4"},"reference-count":52,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,2,4]],"date-time":"2024-02-04T00:00:00Z","timestamp":1707004800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Prostate"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Teverelix drug product (DP) is a novel injectable gonadotropin\u2010releasing hormone antagonist.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>An adaptive phase 2, open\u2010label, multicenter trial was conducted in patients with advanced prostate cancer to evaluate the efficacy and safety of a combined subcutaneous (SC) and intramuscular (IM) loading dose regimen of teverelix DP of 120\u2009mg SC\u2009+\u2009120\u2009mg IM (Group 1; <jats:italic>N<\/jats:italic>\u2009=\u20099) or 180\u2009mg SC\u2009+\u2009180\u2009mg IM (Group 2; <jats:italic>N<\/jats:italic>\u2009=\u200941) administered at a single visit, followed by 6\u2010weekly SC maintenance doses of 120\u2009mg (Group 1) or 180\u2009mg (Group 2), up to Day 168. The primary endpoint was the proportion of patients achieving castration levels with serum testosterone &lt;0.5\u2009ng\/mL at Day 28 with a target castration rate of 90%. Injection sites were inspected by the investigator at every visit and reactions (ISRs) were proactively recorded.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The target castration rate was reached in Group 2 (97.5%) but not in Group 1 (62.5%). The castration rates were not maintained to Day 42 (Group 2: 82.5%; Group 1: 50.0%). Suppression of testosterone to castrate levels occurred rapidly (median time: 2 days for both groups). Suppression of testosterone, prostate\u2010specific antigen, follicle\u2010stimulating hormone, and luteinizing hormone was sustained throughout the treatment period, being more prominent with the higher dose. The adverse event (AE) profile was similar between groups. The most common AEs were injection\u2010site induration (<jats:italic>n<\/jats:italic>\u2009=\u200940: 80.0%), injection\u2010site erythema (<jats:italic>n<\/jats:italic>\u2009=\u200935: 70.0%), and hot flush (<jats:italic>n<\/jats:italic>\u2009=\u200921: 42.0%). Most ISRs were Grade 1.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Overall, the teverelix DP doses were generally well\u2010tolerated but did not adequately maintain castration levels.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pros.24674","type":"journal-article","created":{"date-parts":[[2024,2,7]],"date-time":"2024-02-07T06:45:28Z","timestamp":1707288328000},"page":"584-598","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Efficacy, tolerability, and safety of teverelix DP in patients with advanced prostate cancer: A multicenter, open\u2010label, phase 2 trial"],"prefix":"10.1002","volume":"84","author":[{"given":"Albertas","family":"Ulys","sequence":"first","affiliation":[{"name":"Departments of Urology National Cancer Institute Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Feliksas","family":"Jankevicus","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Departments of Urology Vilnius University Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mindaugas","family":"Jievaltas","sequence":"additional","affiliation":[{"name":"Urology Department, Medicine Academy Lithuanian University of Health Sciences Kaunas Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raimundas","family":"Venckus","sequence":"additional","affiliation":[{"name":"Department of Surgery Klaipeda University Hospital Klaipeda Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stasys","family":"Auskalnis","sequence":"additional","affiliation":[{"name":"Urology Department, Medicine Academy Lithuanian University of Health Sciences Kaunas Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zygimantas","family":"Kardelis","sequence":"additional","affiliation":[{"name":"Departments of Urology National Cancer Institute Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marija","family":"Barisiene","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Departments of Urology Vilnius University Vilnius Lithuania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2948-3734","authenticated-orcid":false,"given":"Carol M.","family":"MacLean","sequence":"additional","affiliation":[{"name":"Antev Ltd London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steve","family":"van Os","sequence":"additional","affiliation":[{"name":"Antev Ltd London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Finn","family":"Larsen","sequence":"additional","affiliation":[{"name":"Antev Ltd London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,4]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/iju.14303"},{"key":"e_1_2_10_3_1","first-page":"10167","article-title":"The role of FSH and LH in prostate cancer and cardiometabolic comorbidities","volume":"27","author":"Crawford ED","year":"2020","journal-title":"Can J Urol"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.urolonc.2017.01.025"},{"key":"e_1_2_10_5_1","unstructured":"Center for Drug Evaluation and Research (CDER). 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