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Trial record 1 of 1 for:    Relugolix HERO
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A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (HERO)

This study is currently recruiting participants.
Verified November 2017 by Myovant Sciences GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT03085095
First Posted: March 21, 2017
Last Update Posted: November 17, 2017
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.
Information provided by (Responsible Party):
Myovant Sciences GmbH
  Purpose
The purpose of this study is to determine the benefit and safety of relugolix 120 mg 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 Intervention Phase
Prostate Cancer Drug: Relugolix Drug: Leuprolide Acetate Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Myovant Sciences GmbH:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 1125
Actual Study Start Date: March 3, 2017
Estimated Study Completion Date: April 30, 2020
Estimated Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relugolix Drug: Relugolix
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

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 1125 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or
    2. Newly diagnosed androgen-sensitive metastatic disease; or
    3. 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);
  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 > 12 months total duration. If androgen deprivation therapy was received for ≤ 12 months total duration, then that therapy must have been completed at least 12 months prior to baseline;
  3. Previous treatment for prostate cancer with a taxane-based regimen;
  4. Metastases to brain per prior clinical evaluation;
  5. Features of the patient's medical condition that make life expectancy due to other medical conditions of less than 5 years;
  6. Scheduled for major surgery after baseline;
  7. History of surgical castration.
  Contacts and Locations
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

  Hide Study Locations
Locations
United States, Alaska
Anchorage Recruiting
Anchorage, Alaska, United States, 99503
United States, Arizona
Tucson Recruiting
Tucson, Arizona, United States, 85741
United States, California
San Diego Recruiting
San Diego, California, United States, 92120
United States, Colorado
Denver Recruiting
Denver, Colorado, United States, 80211
United States, Florida
Pompano Beach Recruiting
Pompano Beach, Florida, United States, 33060
United States, Kansas
Wichita Recruiting
Wichita, Kansas, United States, 67226
United States, Maryland
Towson Recruiting
Towson, Maryland, United States, 21204
United States, Michigan
Troy Recruiting
Troy, Michigan, United States, 48084
United States, Nebraska
Omaha Recruiting
Omaha, Nebraska, United States, 68130
United States, Nevada
Las Vegas Recruiting
Las Vegas, Nevada, United States, 89135
United States, New Jersey
Brick Recruiting
Brick, New Jersey, United States, 08724
Lawrenceville Recruiting
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Albuquerque Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Brooklyn Recruiting
Brooklyn, New York, United States, 11215
Garden City Recruiting
Garden City, New York, United States, 11530
Plainview Recruiting
Plainview, New York, United States, 11803
Poughkeepsie Recruiting
Poughkeepsie, New York, United States, 12601
Syracuse Recruiting
Syracuse, New York, United States, 13210
United States, Ohio
Cincinnati Recruiting
Cincinnati, Ohio, United States, 45212
MiddleBurg Heights Recruiting
Middleburg Heights, Ohio, United States, 44130
Toledo Recruiting
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Lancaster Recruiting
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Myrtle Beach Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
San Antonio Recruiting
San Antonio, Texas, United States, 78229
Australia, New South Wales
Camperdown Recruiting
Camperdown, New South Wales, Australia, 2050
Darlinghurst Recruiting
Darlinghurst, New South Wales, Australia, 2010
Tweed Heads Recruiting
Tweed Heads, New South Wales, Australia, 2485
Wahroonga Recruiting
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Cairns Recruiting
Cairns, Queensland, Australia, 4870
Redcliffe Recruiting
Redcliffe, Queensland, Australia, 4020
Austria
Linz Recruiting
Linz, Austria, A-4010
Salzburg Recruiting
Salzburg, Austria, 5020
Belgium
Brussels Recruiting
Brussels, Belgium, 1200
Kortrijk Recruiting
Kortrijk, Belgium, 8500
Canada, Alberta
Calgary Recruiting
Calgary, Alberta, Canada, T2V1P9
Canada, Nova Scotia
Halifax Recruiting
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Hamilton Recruiting
Hamilton, Ontario, Canada, L8N4A6
London Recruiting
London, Ontario, Canada, N6A5W9
Canada, Quebec
Montreal Recruiting
Montréal, Quebec, Canada, H2X0A9
Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Toronto Recruiting
Toronto, Quebec, Canada, H2X0A9
Canada
Quebec Recruiting
Quebec, Canada
Denmark
Alborg Recruiting
Aalborg, Nordjylland, Denmark, DK-9000
Aarhus Recruiting
Aarhus, Denmark, 8200
Copenhagen Recruiting
Copenhagen, Denmark, 2200
Herlev Recruiting
Herlev, Denmark, 2730
Vejle Recruiting
Vejle, Denmark, DK-7100
Finland
Helsinki Recruiting
Helsinki, Finland, 00029 HUS
Seinajoki Recruiting
Seinäjoki, Finland, FI-60220
Tampere Recruiting
Tampere, Finland, FI-33520
Turku Recruiting
Turku, Finland, FI-20520
France
Strasbourg Recruiting
Strasbourg, Bas-Rhin, France, 67091
Lille Recruiting
Lille, Nord, France, 59037
Pierre Benite Recruiting
Pierre-Bénite, Rhone, France, 69495
Creteil Recruiting
Créteil, Val De Marne, France, 94010
Creteil Recruiting
Créteil, Val-de-Marne, France, 94010
Hyeres Recruiting
Hyères, France, 83400
Lyon Recruiting
Lyon, France, 69437
Nimes Recruiting
Nîmes, France, 30029
Poitiers Recruiting
Poitiers, France, 86021
Germany
Emmendingen Recruiting
Emmendingen, Baden-Wurttemberg, Germany, 79312
Planegg Recruiting
Planegg, Bayern, Germany, 82152
Braunscheweig Recruiting
Braunschweig, Niedersachsen, Germany, 38100
Braunschweig Recruiting
Braunschweig, Niedersachsen, Germany, 38100
Braunschweig Recruiting
Braunschweig, Niedersachsen, Germany, 38126
Dresden Recruiting
Dresden, Germany, 01307
Hamburg Recruiting
Hamburg, Germany, 22399
Japan
Sendai Recruiting
Sendai, Miyagi, Japan, 9808574
Suita Recruiting
Suita, Osaka, Japan, 565-0871
Hiroshima Recruiting
Hiroshima, Japan, 730-8518
Maebashi-shi Recruiting
Maebashi, Japan, 371-8511
Osaka Recruiting
Osaka, Japan
Tokyo Recruiting
Tokyo, Japan, 285-8741
Yokohama City Recruiting
Yokohama, Japan
Korea, Republic of
Busan Recruiting
Busan, Korea, Republic of, 49241
Hwasun-gun Recruiting
Hwasun, Korea, Republic of, 58128
Hwasun-gun Recruiting
Hwasun, Korea, Republic of
Seongnam Recruiting
Seongnam, Korea, Republic of, 13620
Seoul Recruiting
Seoul, Korea, Republic of, 03722
Seoul Recruiting
Seoul, Korea, Republic of, 05505
Seoul Recruiting
Seoul, Korea, Republic of, 06351
Seoul Recruiting
Seoul, Korea, Republic of, 13572
Netherlands
Maastricht Recruiting
Maastricht, Netherlands, 6229HX
Sneek Recruiting
Sneek, Netherlands, 8601 ZK
New Zealand
Hamilton Recruiting
Hamilton, Northland, New Zealand, 3204
Dunedin Recruiting
Dunedin, South Island, New Zealand, 9001
Canterbury Recruiting
Christchurch, New Zealand, 8013
Tauranga Recruiting
Tauranga, New Zealand, 3140
Slovakia
Bratislava Recruiting
Bratislava, Slovakia, 845 05
Kosice Recruiting
Košice, Slovakia, 04001
Nitra Recruiting
Nitra, Slovakia, 94901
Poprad Recruiting
Poprad, Slovakia
Presov Recruiting
Prešov, Slovakia, 080 01
Trencin Recruiting
Trenčín, Slovakia, 911 01
Sula Recruiting
Šula, Slovakia, 927 01
Spain
A Coruna Recruiting
A Coruña, A Coruna, Spain, 15006
Oviedo Recruiting
Oviedo, Asturias, Spain, 33011
Barcelona Recruiting
Barcelona, Spain, 8036
Barcelona Recruiting
Barcelona, Spain
Madrid Recruiting
Madrid, Spain, 28006
Madrid Recruiting
Madrid, Spain, 28041
Sabadell Recruiting
Sabadell, Spain, 08208
Salamanca Recruiting
Salamanca, Spain, 37007
Santiago de Compostela Recruiting
Santiago de Compostela, Spain, 15706
Valencia Recruiting
Valencia, Spain, 46009
Sweden
Orebro Recruiting
Örebro, Orebro Ian, Sweden, SE-70185
Malmo Recruiting
Malmö, Skane Ian, Sweden
Stockholm Recruiting
Stockholm, Sodermandlands Ian, Sweden
Uppsala Recruiting
Uppsala, Sweden, 751 85
Taiwan
Kaohsiung Recruiting
Kaohsiung, Taiwan
Taipei Recruiting
Taipei, Taiwan, 112
Taipei Recruiting
Taipei, Taiwan, 11490
Taipei Recruiting
Taipei, Taiwan
United Kingdom
Aberdeen Recruiting
Aberdeen, United Kingdom, AB252ZN
Plymouth Recruiting
Plymouth, United Kingdom, PL68DH
Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
Study Director: Myovant Medical Monitor Myovant Sciences
  More Information

Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03085095     History of Changes
Other Study ID Numbers: MVT-601-3201
First Submitted: March 9, 2017
First Posted: March 21, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
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