A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (HERO)

Tracking Information
First Submitted Date ICMJE	March 9, 2017
First Posted Date ICMJE	March 21, 2017
Last Update Posted Date	August 17, 2018
Actual Study Start Date ICMJE	March 3, 2017
Estimated Primary Completion Date	September 30, 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 14, 2017)	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
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT03085095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 14, 2017)	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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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 benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (<=50 ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer.
Detailed Description	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 ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Prostate Cancer
Intervention ICMJE	Drug: Relugolix Relugolix 120 mg tablet administered orally once daily; 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
Study Arms	Experimental: Relugolix Intervention: Drug: Relugolix; Active Comparator: Leuprolide Acetate Intervention: Drug: Leuprolide Acetate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: February 27, 2018)	915
Original Estimated Enrollment ICMJE; (submitted: March 14, 2017)	1125
Estimated Study Completion Date	April 30, 2020
Estimated Primary Completion Date	September 30, 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Key Inclusion Criteria: Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate;; Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with one of the following clinical disease state presentations: Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or Newly diagnosed androgen-sensitive metastatic disease; or Advanced localized disease not suitable for local primary surgical intervention with curative intent (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy);; Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nmol/L);; Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 μg/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir;; Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline. Key Exclusion Criteria: In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy;; Previously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot;; Previous systemic cytotoxic treatment for prostate cancer (eg: taxane-based regimen);; Metastases to brain per prior clinical evaluation;; Scheduled for major surgery after baseline;; History of surgical castration.
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Clinical Trials at Myovant 650-278-8743 ClinicalTrials@Myovant.com
Listed Location Countries ICMJE	Australia, Austria, Belgium, Brazil, Canada, 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
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Myovant Sciences GmbH
Study Sponsor ICMJE	Myovant Sciences GmbH
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Myovant Medical Monitor Myovant Sciences
PRS Account	Myovant Sciences GmbH
Verification Date	August 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP