{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T15:45:07Z","timestamp":1789227907602,"version":"build-2803163510"},"reference-count":22,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,5,23]],"date-time":"2018-05-23T00:00:00Z","timestamp":1527033600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Astellas Pharm Inc"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:sec><jats:label\/><jats:p>Non\u2010inferiority in the cumulative castration rate of the 3\u2010month formulation of degarelix compared with the 3\u2010month formulation of goserelin was evaluated in subjects with prostate cancer. A phase III, open\u2010label, parallel\u2010arm study was carried out. An initial dose of 240\u00a0mg degarelix or 3.6\u00a0mg goserelin was given s.c.; after day 28, a maintenance dose of 480\u00a0mg degarelix or 10.8\u00a0mg goserelin was given once every 84\u00a0days. Non\u2010inferiority in castration rate and safety of degarelix to goserelin were evaluated. The primary end\u2010point was the cumulative castration rate from day 28 to day 364 and the non\u2010inferiority margin was set to be 10%. A total of 234 subjects with prostate cancer were randomized to the degarelix group (n\u00a0=\u00a0117) and the goserelin group (n\u00a0=\u00a0117). The cumulative castration rate was 95.1% in the degarelix group and 100.0% in the goserelin group. As there were no events in the goserelin group, an additional analysis was carried out using 95% confidence intervals of the difference in the proportion of subjects with castration. Analyses indicated the non\u2010inferiority of the 3\u2010month formulation of degarelix to goserelin. Degarelix showed more rapid decreases in testosterone, luteinizing hormone, follicle stimulating hormone, and prostate\u2010specific antigen levels compared with goserelin. The most common adverse events in the degarelix group were injection site reactions. Non\u2010inferiority of the 3\u2010month formulation of degarelix to goserelin was shown for testosterone suppression. The 3\u2010month formulation of degarelix was also found to be tolerated as an androgen deprivation therapy for patients with prostate cancer. This trial was registered with ClinicalTrials.gov (identifier NCT01964170).<\/jats:p><\/jats:sec>","DOI":"10.1111\/cas.13600","type":"journal-article","created":{"date-parts":[[2018,4,6]],"date-time":"2018-04-06T22:27:41Z","timestamp":1523053661000},"page":"1920-1929","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Efficacy and safety of 3\u2010month dosing regimen of degarelix in Japanese subjects with prostate cancer: A phase III study"],"prefix":"10.1111","volume":"109","author":[{"given":"Seiichiro","family":"Ozono","sequence":"first","affiliation":[{"name":"Hamamatsu University School of Medicine Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taiji","family":"Tsukamoto","sequence":"additional","affiliation":[{"name":"Sapporo Medical University Hokkaido Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seiji","family":"Naito","sequence":"additional","affiliation":[{"name":"Harasanshin Hospital Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeo","family":"Horie","sequence":"additional","affiliation":[{"name":"Department of Urology Juntendo University Graduate School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuo","family":"Ohashi","sequence":"additional","affiliation":[{"name":"Chuo University Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroji","family":"Uemura","sequence":"additional","affiliation":[{"name":"Yokohama City University Medical Center Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumiko","family":"Yokomizo","sequence":"additional","affiliation":[{"name":"Yokohama City University Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Fukasawa","sequence":"additional","affiliation":[{"name":"Chiba Cancer Center Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1940-2670","authenticated-orcid":false,"given":"Hidehito","family":"Kusuoka","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc. 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