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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 : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Relugolix Drug: Leuprolide Acetate Phase 3

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 1100 patients will be enrolled in this study, including approximately 390 patients with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of time to castration-resistance and 138 Chinese patients (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 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 : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Relugolix
Relugolix 120 mg for 48 weeks
Drug: Relugolix
Relugolix 120 mg tablet administered orally once daily
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 (3-M) by subcutaneous or intramuscular injection




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Castration Rate by Visit [ Time Frame: up to 3 weeks ]
    Castration rate defined as the cumulative probability of testosterone suppression to ≤ 50 ng/dL (1.7 nmol/L) prior to dosing.

  2. 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.

  3. Prostate-specific antigen (PSA) response rate by PCWG3 criteria [ Time Frame: at 3 weeks and at 5 weeks ]
    Proportion of patients with a confirmed PSA response by Prostate Cancer Clinical Trials Working Group 3 guidelines.

  4. PSA response rate [ Time Frame: at 3 weeks and at 5 weeks ]
    Proportion of patients with PSA concentration < 0.2 ng/mL.

  5. Time to PSA progression [ Time Frame: up to 48 weeks ]
    Time from baseline to PSA progression as defined by Prostate Cancer Clinical Trials Working Group 3 guidelines.

  6. Quality of life (QoL) total score and each subdomain score [ Time Frame: up to 48 weeks ]
    Assessed by the EORTC-QLQ-C30 and EORTC-QLQ-PR25 questionnaires.

  7. Time to castration resistance [ 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.

  8. Composite of safety as measure of safety and tolerability [ Time Frame: up to 48 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.

  9. Pharmacokinetics of relugolix [ Time Frame: up to 52 weeks ]
    Blood samples will be collected from participants for measurement of plasma relugolix concentrations.

  10. Serum concentrations of luteinizing hormone, follicle-stimulating hormone, dihydrotestosterone, sex hormone binding globulin [ Time Frame: up to 24 weeks ]
    Blood samples will be collected from participants for hormonal measurements.

  11. Testosterone recovery [ Time Frame: up to 90 days after end of study treatment ]
    Blood samples will be collected from participants for serum testosterone measurements.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 patients are enrolled worldwide only patients with metastatic advanced prostate cancer will be eligible for the study in all regions except China, where both metastatic and non-metastatic patients 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 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;
  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.

Information from the National Library of Medicine

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


Contacts
Contact: Clinical Trials at Myovant 650-278-8743 ClinicalTrials@Myovant.com

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Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
Study Director: Myovant Medical Monitor Myovant Sciences

Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03085095     History of Changes
Other Study ID Numbers: MVT-601-3201
2017-000160-15 ( EudraCT Number )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents