Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial
Introduction This is a multicentre, open-label, single-arm clinical trial to evaluate the efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer.Methods and analysis The trial will be performed at 4 university hospitals and 14 city hospitals in Japan. The...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/3/e070173.full |
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| author | Masato Fujisawa Kenichi Harada Yasumasa Kakei Hideaki Miyake Yuzo Nakano Tomoaki Terakawa Keiko Miyakoda |
| author_facet | Masato Fujisawa Kenichi Harada Yasumasa Kakei Hideaki Miyake Yuzo Nakano Tomoaki Terakawa Keiko Miyakoda |
| author_sort | Masato Fujisawa |
| collection | DOAJ |
| description | Introduction This is a multicentre, open-label, single-arm clinical trial to evaluate the efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer.Methods and analysis The trial will be performed at 4 university hospitals and 14 city hospitals in Japan. The target number of patients will be 110. The patients will be orally administered 240 mg apalutamide once daily during the treatment period. The primary outcome is the prostate-specific antigen (PSA) response rate. PSA response is defined as ≥50% decline from baseline at 12 weeks. Secondary outcomes are time to PSA progression, progression-free survival, overall survival, progression-free survival during second therapy, ≥50% decline in PSA from baseline at 24 and 48 weeks, ≥90% decline in PSA from baseline or lower PSA detection sensitivity after the initial dose at 12, 24 and 48 weeks, PSA maximal changes, accumulated PSA response from screening to 24 and 48 weeks, and grade 3 or 4 adverse events according to the Common Terminology Criteria for Adverse Events version 4.0.Ethics and dissemination This study has been approved by the Certified Research Review Board of Kobe University (No. CRB5180009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publications. The datasets generated during the study will be available from the corresponding author on reasonable request.Trial registration number jRCTs051220077. |
| first_indexed | 2024-03-12T15:14:40Z |
| format | Article |
| id | doaj.art-0986c3087c0f491f85e5ef1514c76946 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:14:40Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-0986c3087c0f491f85e5ef1514c769462023-08-11T15:10:07ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-070173Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trialMasato Fujisawa0Kenichi Harada1Yasumasa Kakei2Hideaki Miyake3Yuzo Nakano4Tomoaki Terakawa5Keiko Miyakoda6Urology, Kobe University Graduate School of Medicine, Kobe, JapanDepartment of Urology, University of Occupational and Environmental Health, Kitakyushu, JapanDepartment of Clinical and Translational Research Center, Kobe University Hospital, Kobe, JapanDepartment of Urology, Hamamatsu, Hamamatsu, JapanUrology, Kobe University Graduate School of Medicine, Kobe, JapanUrology, Kobe University Graduate School of Medicine, Kobe, JapanDepartment of Clinical and Translational Research Center, Kobe University Hospital, Kobe, JapanIntroduction This is a multicentre, open-label, single-arm clinical trial to evaluate the efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer.Methods and analysis The trial will be performed at 4 university hospitals and 14 city hospitals in Japan. The target number of patients will be 110. The patients will be orally administered 240 mg apalutamide once daily during the treatment period. The primary outcome is the prostate-specific antigen (PSA) response rate. PSA response is defined as ≥50% decline from baseline at 12 weeks. Secondary outcomes are time to PSA progression, progression-free survival, overall survival, progression-free survival during second therapy, ≥50% decline in PSA from baseline at 24 and 48 weeks, ≥90% decline in PSA from baseline or lower PSA detection sensitivity after the initial dose at 12, 24 and 48 weeks, PSA maximal changes, accumulated PSA response from screening to 24 and 48 weeks, and grade 3 or 4 adverse events according to the Common Terminology Criteria for Adverse Events version 4.0.Ethics and dissemination This study has been approved by the Certified Research Review Board of Kobe University (No. CRB5180009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publications. The datasets generated during the study will be available from the corresponding author on reasonable request.Trial registration number jRCTs051220077.https://bmjopen.bmj.com/content/13/3/e070173.full |
| spellingShingle | Masato Fujisawa Kenichi Harada Yasumasa Kakei Hideaki Miyake Yuzo Nakano Tomoaki Terakawa Keiko Miyakoda Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial BMJ Open |
| title | Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial |
| title_full | Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial |
| title_fullStr | Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial |
| title_full_unstemmed | Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial |
| title_short | Efficacy and safety of apalutamide in patients with metastatic castration-resistant prostate cancer (GENESIS): protocol for a multicentre, open-label, single-arm clinical trial |
| title_sort | efficacy and safety of apalutamide in patients with metastatic castration resistant prostate cancer genesis protocol for a multicentre open label single arm clinical trial |
| url | https://bmjopen.bmj.com/content/13/3/e070173.full |
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