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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1134

Study ID:

NCT03085095

Recruitment Status:

Completed

Sponsor:

Myovant Sciences GmbH

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There are 162 Locations for this study

See Locations Near You

Tucson
Tucson Arizona, 85741, United States
Orange
Orange California, 92868, United States
Denver
Denver Colorado, 80211, United States
Pompano Beach
Pompano Beach Florida, 33060, United States
Jeffersonville
Jeffersonville Indiana, 47130, United States
Des Moines
Des Moines Iowa, 50266, United States
Wichita
Wichita Kansas, 67226, United States
Baltimore
Baltimore Maryland, 21204, United States
Troy
Troy Michigan, 48084, United States
Omaha
Omaha Nebraska, 68130, United States
Las Vegas
Las Vegas Nevada, 89135, United States
Brick
Brick New Jersey, 08724, United States
Albuquerque
Albuquerque New Mexico, 87109, United States
Albany
Albany New York, 12208, United States
Garden City
Garden City New York, 11530, United States
Plainview
Plainview New York, 11803, United States
Poughkeepsie
Poughkeepsie New York, 12601, United States
Syracuse
Syracuse New York, 13210, United States
Durham
Durham North Carolina, 27710, United States
Greensboro
Greensboro North Carolina, 27403, United States
Cincinnati
Cincinnati Ohio, 45212, United States
Middleburg Heights
Middleburg Heights Ohio, 44130, United States
Oklahoma City
Oklahoma City Oklahoma, 73104, United States
Lancaster
Lancaster Pennsylvania, 17604, United States
Myrtle Beach
Myrtle Beach South Carolina, 29572, United States
Nashville
Nashville Tennessee, 37209, United States
San Antonio
San Antonio Texas, 78258, United States
Camperdown
Camperdown New South Wales, 2050, Australia
Tweed Heads
Tweed Heads New South Wales, 2485, Australia
Wahroonga
Wahroonga New South Wales, 2076, Australia
Redcliffe
Redcliffe Queensland, 4020, Australia
Southport
Southport Queensland, 4215, Australia
Linz
Linz , 402, Austria
Gent
Gent Oost-Vlaanderen, 9000, Belgium
Brussels
Brussels , 1200, Belgium
Kortrijk
Kortrijk , 8500, Belgium
Itabuna
Itabuna Bahia, 45602, Brazil
Salvador
Salvador Bahia, 41253, Brazil
Salvador
Salvador Bahia, 41820, Brazil
Teresina
Teresina Piauí, 64001, Brazil
Natal
Natal Rio Grande Do Norte, 59062, Brazil
Ijuí
Ijuí Rio Grande Do Sul, 98700, Brazil
Passo Fundo
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Porto Alegre
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Porto Alegre
Porto Alegre Rio Grande Do Sul, 90430, Brazil
Joinville
Joinville Santa Catarina, 89201, Brazil
São José Do Rio Preto
São José Do Rio Preto Sao Paulo, 15090, Brazil
Curitiba
Curitiba , 81520, Brazil
Calgary
Calgary Alberta, T2V4R, Canada
Vancouver
Vancouver British Columbia, V5Z1M, Canada
Halifax
Halifax Nova Scotia, B3H2Y, Canada
Hamilton
Hamilton Ontario, L8N4A, Canada
London
London Ontario, N6A4G, Canada
Montreal
Montréal Quebec, H2X0A, Canada
Sherbrooke
Sherbrooke Quebec, J1H5N, Canada
Quebec
Quebec , G1R 3, Canada
Nanjing
Nanjing Jiangsu, 21000, China
Changchun
Chang chun Jilin, 13002, China
Shanghai
Shanghai Shanghai, 02004, China
Taiyuan
Taiyuan Shanxi, 03000, China
Beijing
Beijing , 10004, China
Beijing
Beijing , 10005, China
Beijing Shi
Beijing , 10073, China
Chongqing
Chongqing , 40003, China
Hangzhou
Hangzhou , 31000, China
Lanzhou
Lanzhou , 73003, China
Nanchang
Nanchang , 33000, China
Shanghai
Shanghai , 20004, China
Suzhou
Suzhou , 21500, China
Alborg
Aalborg , DK-90, Denmark
Aarhus
Aarhus , 8200, Denmark
Herlev
Herlev , 2730, Denmark
Vejle
Vejle , DK-71, Denmark
Helsinki
Helsinki , FI-00, Finland
Seinajoki
Seinäjoki , FI-60, Finland
Tampere
Tampere , FI-33, Finland
Turku
Turku , FI-20, Finland
Strasbourg
Strasbourg Bas-Rhin, 67091, France
Pierre Benite
Pierre-Bénite Rhone, 69495, France
Creteil
Créteil Val-de-Marne, 94010, France
Lyon
Lyon , 69437, France
Emmendingen
Emmendingen Baden-Wurttemberg, 79312, Germany
Planegg
Planegg Bayern, 82152, Germany
Braunschweig
Braunschweig Niedersachsen, 38100, Germany
Dresden
Dresden , 01307, Germany
Lubeck
Lübeck , 23538, Germany
Munster
Münster , 48149, Germany
Meldola
Meldola Emilia-Romagna, 47014, Italy
Rome
Rome Lazio, 00152, Italy
Cremona
Cremona Lombardia, 26100, Italy
Candiolo
Candiolo Piemonte, 10060, Italy
Orbassano
Orbassano Piemonte, 10043, Italy
Arezzo
Arezzo Toscana, 52100, Italy
Milano
Milano , 20162, Italy
Kanazawa-shi
Kanazawa-shi Isikawa, 920-8, Japan
Yokohama
Yokohama Kanagawa, 232-0, Japan
Sendai
Sendai Miyagi, 98085, Japan
Sendai
Sendai Miyagi, 98185, Japan
Suita
Suita Osaka, 565-0, Japan
Osaka-sayama
ÅŒsaka-sayama Osaka, 589-8, Japan
Bunkyō-Ku
Bunkyō-Ku Tokyo, 113-8, Japan
Nakano-ku
Nakano-ku Tokyo, 164-8, Japan
Sumida-ku
Sumida-ku Tokyo, 130-8, Japan
Chiba
Chiba , 260-0, Japan
Fukuoka
Fukuoka , 812-0, Japan
Hiroshima
Hiroshima , 730-8, Japan
Kita-gun
Kita , 761-0, Japan
Kyoto
Kyoto , 606-8, Japan
Maebashi
Maebashi , 371-8, Japan
Nagasaki
Nagasaki , 852-8, Japan
Osaka
Osaka , 541-8, Japan
Sapporo
Sapporo , 003-0, Japan
Tokyo
Tokyo , 285-8, Japan
Ube
Ube , 75585, Japan
Goyang-Si
Goyang-si Gyeonggido, 10408, Korea, Republic of
Busan
Busan , 49241, Korea, Republic of
Daegu
Daegu , 41404, Korea, Republic of
Hwasun
Hwasun , 58128, Korea, Republic of
Seoul
Seoul , 03080, Korea, Republic of
Seoul
Seoul , 05505, Korea, Republic of
Seoul
Seoul , 06273, Korea, Republic of
Seoul
Seoul , 06351, Korea, Republic of
Eindhoven
Eindhoven Noord Brabant, 5623E, Netherlands
Amsterdam
Amsterdam Noord Holland, 1105A, Netherlands
Sneek
Sneek , 8601 , Netherlands
Christchurch
Christchurch , 8013, New Zealand
Dunedin
Dunedin , 9016, New Zealand
Hamilton
Hamilton , 3204, New Zealand
Tauranga
Tauranga , 3112, New Zealand
Lublin
Lublin Lubelskie, 20-58, Poland
Siedlce
Siedlce Mazowieckie, 08-11, Poland
Warszawa
Warszawa Mazowieckie, 02-79, Poland
Gdynia
Gdynia Pomorskie, 81-51, Poland
Katowice
Katowice , 40611, Poland
Bratislava
Bratislava , 851 0, Slovakia
Kosice
Košice , 040 0, Slovakia
Kosice
Košice , 041 9, Slovakia
Martin
Martin , 036 5, Slovakia
Nitra
Nitra , 949 0, Slovakia
Poprad
Poprad , 058 4, Slovakia
Presov
Prešov , 080 0, Slovakia
Trencin
Trenčín , 911 0, Slovakia
Sala
Šaľa , 927 0, Slovakia
A Coruna
A Coruña A Coruna, 15706, Spain
Oviedo
Oviedo Asturias, 33011, Spain
Barcelona
Barcelona , 08036, Spain
Madrid
Madrid , 28007, Spain
Madrid
Madrid , 28041, Spain
Salamanca
Salamanca , 37007, Spain
Valencia
Valencia , 46009, Spain
Orebro
Örebro Orebro Ian, SE-70, Sweden
Stockholm
Stockholm Sodermandlands Ian, SE-17, Sweden
Uppsala
Uppsala Uppsala Lan, SE-75, Sweden
Malmo
Malmö , SE-20, Sweden
Kaohsiung City
Kaohsiung City , 807, Taiwan
Taipei
Taipei , 100, Taiwan
Taipei
Taipei , 111, Taiwan
Taipei
Taipei , 11490, Taiwan
Exeter
Exeter Devon, EX2 5, United Kingdom
Scunthorpe
Scunthorpe North Lincolnshire, DN157, United Kingdom
Nottingham
Nottingham , NG5 1, United Kingdom
Rhyl
Rhyl , LL18 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1134

Study ID:

NCT03085095

Recruitment Status:

Completed

Sponsor:


Myovant Sciences GmbH

How clear is this clinincal trial information?

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