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Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

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Trial Identification

Brief Title: A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

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

Study ID: NCT03085095

Conditions

Prostate Cancer

Study Description

Brief Summary: The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (\< 50 nanograms/deciliter \[ng/dL\]) in participants with androgen-sensitive advanced prostate cancer.

Detailed Description: This is a phase 3, multinational, randomized, open-label, parallel group study to evaluate the efficacy and safety of oral daily relugolix 120 mg in participants with androgen-sensitive advanced prostate cancer who require at least 1 year of continuous androgen-deprivation therapy. Relugolix 120 mg orally once daily or leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan based on local labels), every 3 months by subcutaneous injection will be administered to participants. There are 2 analyses for this study, a primary analysis and a final analysis. Primary Analysis: The primary analysis of efficacy and safety has been completed (N=934). Participants were randomized 2:1 to receive relugolix or leuprolide for 48 weeks, followed by a 30-day safety follow-up visit or early termination 30-day safety follow-up. Final Analysis: The final analysis will occur after additional participants with metastatic disease (approximately 130) have been enrolled and randomized from any sites to the study, and have completed the 48-week treatment period. A cohort of participants enrolled in China and Taiwan will be analyzed separately once they have completed treatment to support registration in China. Eligible participants were randomized 2:1 to relugolix or leuprolide arm 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. Castration resistance-free survival will be assessed up to Week 49, Day 1 of the study and reported as part of the final analysis. The study enrolled 1134 participants, including 139 participants with metastatic advanced prostate cancer to support the analysis of the secondary endpoint of castration resistance-free survival and 93 Chinese participants (enrolled in China and Taiwan) to support registration in China.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Tucson, Tucson, Arizona, United States

Orange, Orange, California, United States

Denver, Denver, Colorado, United States

Pompano Beach, Pompano Beach, Florida, United States

Jeffersonville, Jeffersonville, Indiana, United States

Des Moines, Des Moines, Iowa, United States

Wichita, Wichita, Kansas, United States

Baltimore, Baltimore, Maryland, United States

Troy, Troy, Michigan, United States

Omaha, Omaha, Nebraska, United States

Las Vegas, Las Vegas, Nevada, United States

Brick, Brick, New Jersey, United States

Albuquerque, Albuquerque, New Mexico, United States

Albany, Albany, New York, United States

Garden City, Garden City, New York, United States

Plainview, Plainview, New York, United States

Poughkeepsie, Poughkeepsie, New York, United States

Syracuse, Syracuse, New York, United States

Durham, Durham, North Carolina, United States

Greensboro, Greensboro, North Carolina, United States

Cincinnati, Cincinnati, Ohio, United States

Middleburg Heights, Middleburg Heights, Ohio, United States

Oklahoma City, Oklahoma City, Oklahoma, United States

Lancaster, Lancaster, Pennsylvania, United States

Myrtle Beach, Myrtle Beach, South Carolina, United States

Nashville, Nashville, Tennessee, United States

San Antonio, San Antonio, Texas, United States

Camperdown, Camperdown, New South Wales, Australia

Tweed Heads, Tweed Heads, New South Wales, Australia

Wahroonga, Wahroonga, New South Wales, Australia

Redcliffe, Redcliffe, Queensland, Australia

Southport, Southport, Queensland, Australia

Linz, Linz, , Austria

Gent, Gent, Oost-Vlaanderen, Belgium

Brussels, Brussels, , Belgium

Kortrijk, Kortrijk, , Belgium

Itabuna, Itabuna, Bahia, Brazil

Salvador, Salvador, Bahia, Brazil

Salvador, Salvador, Bahia, Brazil

Teresina, Teresina, Piauí, Brazil

Natal, Natal, Rio Grande Do Norte, Brazil

Ijuí, Ijuí, Rio Grande Do Sul, Brazil

Passo Fundo, Passo Fundo, Rio Grande Do Sul, Brazil

Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil

Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil

Joinville, Joinville, Santa Catarina, Brazil

São José Do Rio Preto, São José Do Rio Preto, Sao Paulo, Brazil

Curitiba, Curitiba, , Brazil

Calgary, Calgary, Alberta, Canada

Vancouver, Vancouver, British Columbia, Canada

Halifax, Halifax, Nova Scotia, Canada

Hamilton, Hamilton, Ontario, Canada

London, London, Ontario, Canada

Montreal, Montréal, Quebec, Canada

Sherbrooke, Sherbrooke, Quebec, Canada

Quebec, Quebec, , Canada

Nanjing, Nanjing, Jiangsu, China

Changchun, Chang chun, Jilin, China

Shanghai, Shanghai, Shanghai, China

Taiyuan, Taiyuan, Shanxi, China

Beijing, Beijing, , China

Beijing, Beijing, , China

Beijing Shi, Beijing, , China

Chongqing, Chongqing, , China

Hangzhou, Hangzhou, , China

Lanzhou, Lanzhou, , China

Nanchang, Nanchang, , China

Shanghai, Shanghai, , China

Suzhou, Suzhou, , China

Alborg, Aalborg, , Denmark

Aarhus, Aarhus, , Denmark

Herlev, Herlev, , Denmark

Vejle, Vejle, , Denmark

Helsinki, Helsinki, , Finland

Seinajoki, Seinäjoki, , Finland

Tampere, Tampere, , Finland

Turku, Turku, , Finland

Strasbourg, Strasbourg, Bas-Rhin, France

Pierre Benite, Pierre-Bénite, Rhone, France

Creteil, Créteil, Val-de-Marne, France

Lyon, Lyon, , France

Emmendingen, Emmendingen, Baden-Wurttemberg, Germany

Planegg, Planegg, Bayern, Germany

Braunschweig, Braunschweig, Niedersachsen, Germany

Dresden, Dresden, , Germany

Lubeck, Lübeck, , Germany

Munster, Münster, , Germany

Meldola, Meldola, Emilia-Romagna, Italy

Rome, Rome, Lazio, Italy

Cremona, Cremona, Lombardia, Italy

Candiolo, Candiolo, Piemonte, Italy

Orbassano, Orbassano, Piemonte, Italy

Arezzo, Arezzo, Toscana, Italy

Milano, Milano, , Italy

Kanazawa-shi, Kanazawa-shi, Isikawa, Japan

Yokohama, Yokohama, Kanagawa, Japan

Sendai, Sendai, Miyagi, Japan

Sendai, Sendai, Miyagi, Japan

Suita, Suita, Osaka, Japan

Osaka-sayama, Ōsaka-sayama, Osaka, Japan

Bunkyō-Ku, Bunkyō-Ku, Tokyo, Japan

Nakano-ku, Nakano-ku, Tokyo, Japan

Sumida-ku, Sumida-ku, Tokyo, Japan

Chiba, Chiba, , Japan

Fukuoka, Fukuoka, , Japan

Hiroshima, Hiroshima, , Japan

Kita-gun, Kita, , Japan

Kyoto, Kyoto, , Japan

Maebashi, Maebashi, , Japan

Nagasaki, Nagasaki, , Japan

Osaka, Osaka, , Japan

Sapporo, Sapporo, , Japan

Tokyo, Tokyo, , Japan

Ube, Ube, , Japan

Goyang-Si, Goyang-si, Gyeonggido, Korea, Republic of

Busan, Busan, , Korea, Republic of

Daegu, Daegu, , Korea, Republic of

Hwasun, Hwasun, , Korea, Republic of

Seoul, Seoul, , Korea, Republic of

Seoul, Seoul, , Korea, Republic of

Seoul, Seoul, , Korea, Republic of

Seoul, Seoul, , Korea, Republic of

Eindhoven, Eindhoven, Noord Brabant, Netherlands

Amsterdam, Amsterdam, Noord Holland, Netherlands

Sneek, Sneek, , Netherlands

Christchurch, Christchurch, , New Zealand

Dunedin, Dunedin, , New Zealand

Hamilton, Hamilton, , New Zealand

Tauranga, Tauranga, , New Zealand

Lublin, Lublin, Lubelskie, Poland

Siedlce, Siedlce, Mazowieckie, Poland

Warszawa, Warszawa, Mazowieckie, Poland

Gdynia, Gdynia, Pomorskie, Poland

Katowice, Katowice, , Poland

Bratislava, Bratislava, , Slovakia

Kosice, Košice, , Slovakia

Kosice, Košice, , Slovakia

Martin, Martin, , Slovakia

Nitra, Nitra, , Slovakia

Poprad, Poprad, , Slovakia

Presov, Prešov, , Slovakia

Trencin, Trenčín, , Slovakia

Sala, Šaľa, , Slovakia

A Coruna, A Coruña, A Coruna, Spain

Oviedo, Oviedo, Asturias, Spain

Barcelona, Barcelona, , Spain

Madrid, Madrid, , Spain

Madrid, Madrid, , Spain

Salamanca, Salamanca, , Spain

Valencia, Valencia, , Spain

Orebro, Örebro, Orebro Ian, Sweden

Stockholm, Stockholm, Sodermandlands Ian, Sweden

Uppsala, Uppsala, Uppsala Lan, Sweden

Malmo, Malmö, , Sweden

Kaohsiung City, Kaohsiung City, , Taiwan

Taipei, Taipei, , Taiwan

Taipei, Taipei, , Taiwan

Taipei, Taipei, , Taiwan

Exeter, Exeter, Devon, United Kingdom

Scunthorpe, Scunthorpe, North Lincolnshire, United Kingdom

Nottingham, Nottingham, , United Kingdom

Rhyl, Rhyl, , United Kingdom

Contact Details

Name: Myovant Medical Monitor

Affiliation: Myovant Sciences

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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