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 : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Relugolix Drug: Leuprolide Acetate||Phase 3|
This study is an international phase 3 randomized, open-label, parallel group efficacy and safety study to evaluate oral daily relugolix 120 mg in patients with androgen-sensitive advanced prostate cancer who require at least 1 year (48 weeks) of continuous androgen deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in some Asian countries), every 3-months (3-M) by subcutaneous or intramuscular injection will be administered to patients with prostate cancer who require androgen deprivation therapy.
Approximately 915 patients will be enrolled in this study. The study includes a Screening Period, a Treatment Period of 48 weeks, and a Follow-up Period. Additionally, unscheduled follow-up visit(s) may be arranged for patients with study-related safety concerns as needed. Eligible patients include those with evidence of biochemical relapse (rising PSA) following local primary intervention with curative intent, newly diagnosed metastatic disease (excluding metastases to the brain), and/or advanced localized disease.
Following successful completion of the Screening period study participants will be randomized 2:1 to oral relugolix 120 mg once daily or leuprolide acetate 22.5 mg (or 11.25 mg in some Asian countries) 3-M depot subcutaneous or intramuscular injection and will attend visits monthly (ie, every 4 weeks) where serum testosterone and PSA 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||915 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 3, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||April 30, 2020|
Relugolix 120 mg tablet administered orally once daily
|Active Comparator: Leuprolide Acetate||
Drug: Leuprolide Acetate
leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in some Asian countries), every 3-months (3-M) by subcutaneous or intramuscular injection
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085095
|Contact: Clinical Trials at Myovant||650-278-8743||ClinicalTrials@Myovant.com|
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|Study Director:||Myovant Medical Monitor||Myovant Sciences|