Prostate Cancer Clinical Trial
A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
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.
Full 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.
Eligibility Criteria
Key Inclusion Criteria:
Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.
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 1 of the following clinical disease state presentations:
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
Newly diagnosed androgen-sensitive metastatic disease; or
Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent.
Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles [nmol]/liter [L]).
Has a serum PSA concentration at the Screening visit of > 2.0 ng/milliliter (mL) (2.0 microgram [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.
Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.
Key Exclusion Criteria:
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.
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.
Previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen).
Metastases to brain per prior clinical evaluation.
Participants with myocardial infarction, unstable symptomatic ischemic heart disease, cerebrovascular events, or any significant cardiac condition within the prior 6 months.
Active conduction system abnormalities.
Uncontrolled hypertension.
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There are 162 Locations for this study
Tucson Arizona, 85741, United States
Orange California, 92868, United States
Denver Colorado, 80211, United States
Pompano Beach Florida, 33060, United States
Jeffersonville Indiana, 47130, United States
Des Moines Iowa, 50266, United States
Wichita Kansas, 67226, United States
Baltimore Maryland, 21204, United States
Troy Michigan, 48084, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89135, United States
Brick New Jersey, 08724, United States
Albuquerque New Mexico, 87109, United States
Albany New York, 12208, United States
Garden City New York, 11530, United States
Plainview New York, 11803, United States
Poughkeepsie New York, 12601, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27403, United States
Cincinnati Ohio, 45212, United States
Middleburg Heights Ohio, 44130, United States
Oklahoma City Oklahoma, 73104, United States
Lancaster Pennsylvania, 17604, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37209, United States
San Antonio Texas, 78258, United States
Camperdown New South Wales, 2050, Australia
Tweed Heads New South Wales, 2485, Australia
Wahroonga New South Wales, 2076, Australia
Redcliffe Queensland, 4020, Australia
Southport Queensland, 4215, Australia
Linz , 402, Austria
Gent Oost-Vlaanderen, 9000, Belgium
Brussels , 1200, Belgium
Kortrijk , 8500, Belgium
Itabuna Bahia, 45602, Brazil
Salvador Bahia, 41253, Brazil
Salvador Bahia, 41820, Brazil
Teresina PiauÃ, 64001, Brazil
Natal Rio Grande Do Norte, 59062, Brazil
Ijuà Rio Grande Do Sul, 98700, Brazil
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Porto Alegre Rio Grande Do Sul, 90430, Brazil
Joinville Santa Catarina, 89201, Brazil
São José Do Rio Preto Sao Paulo, 15090, Brazil
Curitiba , 81520, Brazil
Calgary Alberta, T2V4R, Canada
Vancouver British Columbia, V5Z1M, Canada
Halifax Nova Scotia, B3H2Y, Canada
Hamilton Ontario, L8N4A, Canada
London Ontario, N6A4G, Canada
Montréal Quebec, H2X0A, Canada
Sherbrooke Quebec, J1H5N, Canada
Quebec , G1R 3, Canada
Nanjing Jiangsu, 21000, China
Chang chun Jilin, 13002, China
Shanghai Shanghai, 02004, China
Taiyuan Shanxi, 03000, China
Beijing , 10004, China
Beijing , 10005, China
Beijing , 10073, China
Chongqing , 40003, China
Hangzhou , 31000, China
Lanzhou , 73003, China
Nanchang , 33000, China
Shanghai , 20004, China
Suzhou , 21500, China
Aalborg , DK-90, Denmark
Aarhus , 8200, Denmark
Herlev , 2730, Denmark
Vejle , DK-71, Denmark
Helsinki , FI-00, Finland
Seinäjoki , FI-60, Finland
Tampere , FI-33, Finland
Turku , FI-20, Finland
Strasbourg Bas-Rhin, 67091, France
Pierre-Bénite Rhone, 69495, France
Créteil Val-de-Marne, 94010, France
Lyon , 69437, France
Emmendingen Baden-Wurttemberg, 79312, Germany
Planegg Bayern, 82152, Germany
Braunschweig Niedersachsen, 38100, Germany
Dresden , 01307, Germany
Lübeck , 23538, Germany
Münster , 48149, Germany
Meldola Emilia-Romagna, 47014, Italy
Rome Lazio, 00152, Italy
Cremona Lombardia, 26100, Italy
Candiolo Piemonte, 10060, Italy
Orbassano Piemonte, 10043, Italy
Arezzo Toscana, 52100, Italy
Milano , 20162, Italy
Kanazawa-shi Isikawa, 920-8, Japan
Yokohama Kanagawa, 232-0, Japan
Sendai Miyagi, 98085, Japan
Sendai Miyagi, 98185, Japan
Suita Osaka, 565-0, Japan
ÅŒsaka-sayama Osaka, 589-8, Japan
BunkyÅ-Ku Tokyo, 113-8, Japan
Nakano-ku Tokyo, 164-8, Japan
Sumida-ku Tokyo, 130-8, Japan
Chiba , 260-0, Japan
Fukuoka , 812-0, Japan
Hiroshima , 730-8, Japan
Kita , 761-0, Japan
Kyoto , 606-8, Japan
Maebashi , 371-8, Japan
Nagasaki , 852-8, Japan
Osaka , 541-8, Japan
Sapporo , 003-0, Japan
Tokyo , 285-8, Japan
Ube , 75585, Japan
Goyang-si Gyeonggido, 10408, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 41404, Korea, Republic of
Hwasun , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Eindhoven Noord Brabant, 5623E, Netherlands
Amsterdam Noord Holland, 1105A, Netherlands
Sneek , 8601 , Netherlands
Christchurch , 8013, New Zealand
Dunedin , 9016, New Zealand
Hamilton , 3204, New Zealand
Tauranga , 3112, New Zealand
Lublin Lubelskie, 20-58, Poland
Siedlce Mazowieckie, 08-11, Poland
Warszawa Mazowieckie, 02-79, Poland
Gdynia Pomorskie, 81-51, Poland
Katowice , 40611, Poland
Bratislava , 851 0, Slovakia
Košice , 040 0, Slovakia
Košice , 041 9, Slovakia
Martin , 036 5, Slovakia
Nitra , 949 0, Slovakia
Poprad , 058 4, Slovakia
Prešov , 080 0, Slovakia
TrenÄÃn , 911 0, Slovakia
Šaľa , 927 0, Slovakia
A Coruña A Coruna, 15706, Spain
Oviedo Asturias, 33011, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Salamanca , 37007, Spain
Valencia , 46009, Spain
Örebro Orebro Ian, SE-70, Sweden
Stockholm Sodermandlands Ian, SE-17, Sweden
Uppsala Uppsala Lan, SE-75, Sweden
Malmö , SE-20, Sweden
Kaohsiung City , 807, Taiwan
Taipei , 100, Taiwan
Taipei , 111, Taiwan
Taipei , 11490, Taiwan
Exeter Devon, EX2 5, United Kingdom
Scunthorpe North Lincolnshire, DN157, United Kingdom
Nottingham , NG5 1, United Kingdom
Rhyl , LL18 , United Kingdom
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