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 : December 10, 2019
|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 participants 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 by subcutaneous or intramuscular injection will be administered to participants with prostate cancer who require androgen deprivation therapy.
Approximately 1100 participants will be enrolled in this study, including approximately 390 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of time to castration-resistance and 138 Chinese participants (enrolled in China and Taiwan) to support registration in China. 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 participants with study-related safety concerns as needed. Eligible participants include those with evidence of biochemical relapse (rising prostate-specific antigen) 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-month depot subcutaneous or intramuscular injection 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 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 :||April 18, 2017|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||July 31, 2020|
Relugolix 120 mg for 48 weeks
Relugolix 120 mg tablet administered orally once daily following an oral loading dose of 360 mg on Day 1
Other Name: TAK-385
Active Comparator: Leuprolide Acetate
Leuprolide acetate 22.5 mg (or 11.25 mg in some Asian countries) for 48 weeks
Drug: Leuprolide Acetate
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in some Asian countries), every 3-months by subcutaneous or intramuscular injection
- Sustained Castration Rate [ Time Frame: up to 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: up to 5 weeks ]Castration rate defined as the cumulative probability of testosterone suppression to ≤ 50 ng/dL (1.7 nmol/L).
- Profound Castration Rate [ Time Frame: up to 48 weeks ]Castration rate defined as the cumulative probability of testosterone suppression to ≤ 20 ng/dL (0.7 nmol/L) while on study treatment.
- Prostate-specific Antigen (PSA) Response Rate by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria [ Time Frame: at 3 weeks and at 5 weeks ]Proportion of participants with a confirmed PSA response by PCWG3 guidelines.
- PSA Response Rate [ Time Frame: up to 48 weeks ]Proportion of participants with PSA concentration < 0.2 ng/mL.
- Time to PSA Progression [ Time Frame: up to 48 weeks ]Time from baseline to PSA progression as defined by PCWG3 guidelines.
- Quality of Life (QoL) Total Score and Each Subdomain Score [ Time Frame: up to 48 weeks ]Assessed by the European Organisation of Research and Treatment of Cancer (EORTC)-QLQ-C30 and EORTC-QLQ-PR25 questionnaires.
- QoL Total Score and Each Subdomain Score [ Time Frame: up to 48 weeks ]Assessed by the European Quality of Life 5-Dimension 5-Level questionnaire.
- Castration Resistance Free Survival [ Time Frame: up to 48 weeks ]Defined as the time from the date of first dose to the date of PSA progression while castrated or death due to any reason, whichever occurs earlier.
- Composite of Safety as Measure of Safety and Tolerability [ Time Frame: up to 52 weeks ]Safety will be evaluated by the incidence of serious adverse events, incidence and severity of adverse events, incidence of permanent treatment discontinuation due to adverse events, and incidence of new clinically significant changes in clinical laboratory values and vital signs.
- Pharmacokinetics of Relugolix [ Time Frame: up to 48 weeks ]Blood samples will be collected from participants for measurement of plasma relugolix concentrations.
- Serum Concentrations of Luteinizing Hormone, Follicle-Stimulating Hormone, Dihydrotestosterone, Sex Hormone-Binding Globulin [ Time Frame: up to 61 weeks ]Blood samples will be collected from participants for hormonal measurements.
- Testosterone Recovery [ Time Frame: up to 90-days follow-up ]Blood samples will be collected from participants for serum testosterone measurements.
- Sustained Profound Castration Rate [ Time Frame: up to 48 weeks ]Sustained profound castration rate defined as the cumulative probability of testosterone suppression to ≤ 20 ng/dL (0.7 nmol/L) while on study treatment.
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|
|Study Director:||Myovant Medical Monitor||Myovant Sciences|