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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Name: Myovant Medical Monitor
Affiliation: Myovant Sciences
Role: STUDY_DIRECTOR