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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03085095
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE March 9, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date March 30, 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
 (submitted: November 7, 2019)
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
Original 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • 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.
Original 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.
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 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 participants 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 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  ICMJE Interventional
Study Phase  ICMJE 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 following an oral loading dose of 360 mg on Day 1
    Other Name: TAK-385
  • 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
Study Arms  ICMJE
  • Experimental: Relugolix
    Relugolix 120 mg for 48 weeks
    Intervention: Drug: Relugolix
  • Active Comparator: Leuprolide Acetate
    Leuprolide acetate 22.5 mg (or 11.25 mg in some Asian countries) for 48 weeks
    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: November 13, 2018)
1100
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
1125
Estimated Study Completion Date  ICMJE July 31, 2020
Actual Primary Completion Date October 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate;
  2. 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:

    1. 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; or
    2. Newly diagnosed androgen-sensitive metastatic disease; or
    3. Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent

    Note: Once 915 participants are enrolled worldwide only participants with metastatic advanced prostate cancer will be eligible for the study in all regions except China, where both metastatic and non-metastatic participants will continue to be enrolled.

  3. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nmol/L);
  4. 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;
  5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline.

Key Exclusion Criteria:

  1. 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;
  2. Previously received gonadotropin-releasing hormone 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;
  3. Previous systemic cytotoxic treatment for prostate cancer (eg, taxane-based regimen);
  4. Metastases to brain per prior clinical evaluation;
  5. Scheduled for major surgery after baseline;
  6. History of surgical castration.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials at Myovant 650-278-8743 ClinicalTrials@Myovant.com
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 )
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  ICMJE
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 March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP