A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (HERO)
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ClinicalTrials.gov Identifier: NCT03085095 |
Recruitment Status :
Recruiting
First Posted : March 21, 2017
Last Update Posted : October 29, 2020
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Tracking Information | |||||||
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First Submitted Date ICMJE | March 9, 2017 | ||||||
First Posted Date ICMJE | March 21, 2017 | ||||||
Last Update Posted Date | October 29, 2020 | ||||||
Actual Study Start Date ICMJE | April 18, 2017 | ||||||
Actual Primary Completion Date | October 25, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Sustained Castration Rate [ Time Frame: From Week 5 Day 1 to Week 49 Day 1 ] Sustained castration rate defined as the cumulative probability of testosterone suppression to < 50 ng/dL (1.7 nmol/L) for relugolix while on study treatment from Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337).
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Original Primary Outcome Measures ICMJE |
Sustained Castration Rate [ Time Frame: 48 weeks ] Sustained castration rate defined as the cumulative probability of testosterone suppression to ≤ 50 ng/dL (1.7 nmol/L) while on study treatment from Week 5 through Week 48
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Castration Rate by Visit [ Time Frame: 1, 2, and3 weeks ] Castration rate defined as the cumulative probability of testosterone suppression to ≤ 50 ng/dL (1.7 nmol/L) prior to dosing on Week 1 , prior to dosing on Week 2, and prior to dosing on Week 3.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer | ||||||
Official Title ICMJE | HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer | ||||||
Brief Summary | The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer. | ||||||
Detailed Description | This is a phase 3, multinational, randomized, open-label, parallel group study to evaluate the efficacy and safety of oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year of continuous androgen-deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan based on local labels), every 3 months by subcutaneous injection will be administered to participants. There are 2 analyses for this study, a primary analysis and a final analysis. Primary Analysis: The primary analysis of efficacy and safety has been completed (N=934). Participants were randomized 2:1 to receive relugolix or leuprolide for 48 weeks, followed by a 30-day safety follow-up visit or early termination 30-day safety follow-up. Final Analysis: The final analysis will occur after additional participants with metastatic disease (approximately 130) have been enrolled and randomized from any sites to the study, and have completed the 48-week treatment period. A cohort of participants being enrolled in China and Taiwan will be analyzed separately once they have completed treatment to support registration in China. Eligible participants will be randomized 2:1 to relugolix or leuprolide arm and will attend visits monthly (every 4 weeks) where serum testosterone and prostate-specific antigen will be assessed. Safety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms. Castration resistance-free survival will be assessed up to Week 49, Day 1 of the study and reported as part of the final analysis. Approximately 1100 participants will be enrolled in this study, including approximately 130 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of castration resistance-free survival and approximately 130 Chinese participants (enrolled in China and Taiwan) to support registration in China. Note: To support registration in China, the study will continue to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 130 participants. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B; HERO Study Investigators. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187-2196. doi: 10.1056/NEJMoa2004325. Epub 2020 May 29. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
1100 | ||||||
Original Estimated Enrollment ICMJE |
1125 | ||||||
Estimated Study Completion Date ICMJE | November 1, 2021 | ||||||
Actual Primary Completion Date | October 25, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Slovakia, Spain, Sweden, Taiwan, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03085095 | ||||||
Other Study ID Numbers ICMJE | MVT-601-3201 2017-000160-15 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Myovant Sciences GmbH | ||||||
Study Sponsor ICMJE | Myovant Sciences GmbH | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Myovant Sciences GmbH | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |