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


Condition: Prostate Cancer

Intervention:

  • Drug: Relugolix
  • Drug: Leuprolide Acetate

Purpose: The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (≤ 50 ng/dL [1.7 nmol/L] in participants with androgen-sensitive advanced prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03085095

Sponsor: Myovant Sciences GmbH

Primary Outcome Measures:

  • Measure: Sustained Castration Rate
  • Time Frame: up to 48 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Castration Rate by Visit
  • Time Frame: up to 5 weeks
  • Safety Issue:
  • Measure: Profound Castration Rate
  • Time Frame: up to 48 weeks
  • Safety Issue:
  • Measure: Prostate-specific Antigen (PSA) Response Rate by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria
  • Time Frame: at 3 weeks and at 5 weeks
  • Safety Issue:
  • Measure: PSA Response Rate
  • Time Frame: up to 48 weeks
  • Safety Issue:
  • Measure: Time to PSA Progression
  • Time Frame: up to 48 weeks
  • Safety Issue:
  • Measure: Quality of Life (QoL) Total Score and Each Subdomain Score
  • Time Frame: up to 48 weeks
  • Safety Issue:
  • Measure: QoL Total Score and Each Subdomain Score
  • Time Frame: up to 48 weeks
  • Safety Issue:
  • Measure: Castration Resistance Free Survival
  • Time Frame: up to 48 weeks
  • Safety Issue:
  • Measure: Composite of Safety as Measure of Safety and Tolerability
  • Time Frame: up to 52 weeks
  • Safety Issue:
  • Measure: Pharmacokinetics of Relugolix
  • Time Frame: up to 48 weeks
  • Safety Issue:
  • Measure: Serum Concentrations of Luteinizing Hormone, Follicle-Stimulating Hormone, Dihydrotestosterone, Sex Hormone-Binding Globulin
  • Time Frame: up to 61 weeks
  • Safety Issue:
  • Measure: Testosterone Recovery
  • Time Frame: up to 90-days follow-up
  • Safety Issue:
  • Measure: Sustained Profound Castration Rate
  • Time Frame: up to 48 weeks
  • Safety Issue:

Estimated Enrollment: 1100

Study Start Date: April 18, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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:
  3. 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
  4. Newly diagnosed androgen-sensitive metastatic disease; or
  5. Advanced localized disease unlikely to be cured by local primary intervention with either surgery or radiation with curative intent Note: Once 915 participants are enrolled worldwide only participants with metastatic advanced prostate cancer will be eligible for the study in all regions except China, where both metastatic and non-metastatic participants will continue to be enrolled.
  6. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nmol/L);
  7. 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;
  8. 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 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;
  3. Previous systemic cytotoxic treatment for prostate cancer (eg, taxane-based regimen);
  4. Metastases to brain per prior clinical evaluation;
  5. Scheduled for major surgery after baseline;
  6. History of surgical castration.

Contact:

  • Clinical Trials at Myovant
  • 650-278-8743

Locations:

  • Homewood
  • Homewood Alabama 35209 United States
  • Anchorage
  • Anchorage Alaska 99503 United States
  • Tucson
  • Tucson Arizona 85741 United States
  • Orange
  • Orange California 92868 United States
  • San Diego
  • San Diego California 92120 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
  • Towson
  • Towson 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
  • Lawrenceville
  • Lawrenceville New Jersey 08648 United States
  • Albuquerque
  • Albuquerque New Mexico 87109 United States
  • Albany
  • Albany New York 12208 United States
  • Brooklyn
  • Brooklyn New York 11215 United States
  • Garden City
  • Garden City New York 11530 United States
  • New York
  • New York New York 10029 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
  • Winston-Salem
  • Winston-Salem North Carolina 27157 United States
  • Cincinnati
  • Cincinnati Ohio 45212 United States
  • MiddleBurg Heights
  • Middleburg Heights Ohio 44130 United States
  • Toledo
  • Toledo Ohio 43614 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
  • Dallas
  • Dallas Texas 75231 United States
  • San Antonio
  • San Antonio Texas 78229 United States
  • Virginia Beach
  • Virginia Beach Virginia 23462 United States
  • Camperdown
  • Camperdown New South Wales 2050 Australia
  • Darlinghurst
  • Darlinghurst New South Wales 2010 Australia
  • Tweed Heads
  • Tweed Heads New South Wales 2485 Australia
  • Wahroonga
  • Wahroonga New South Wales 2076 Australia
  • Westmead
  • Westmead New South Wales 2145 Australia
  • Cairns
  • Cairns Queensland 4870 Australia
  • Redcliffe
  • Redcliffe Queensland 4020 Australia
  • Geelong
  • Geelong Victoria 3220 Australia
  • Herston
  • Herston Australia
  • Linz
  • Linz A-4010 Austria
  • Salzburg
  • Salzburg 5020 Austria
  • Edegem
  • Edegem Antwerpen 2650 Belgium
  • Gent
  • Gent Oost-Vlaanderen 9000 Belgium
  • Leuven
  • Leuven Vlaams Brabant 3000 Belgium
  • Brussels
  • Brussels 1200 Belgium
  • Kortrijk
  • Kortrijk 8500 Belgium
  • Itabuna
  • Itabuna Bahia 45602 Brazil
  • Salvador
  • Salvador Bahia 40050 Brazil
  • Salvador
  • Salvador Bahia 41820 Brazil
  • Curitiba
  • Curitiba Paraná 80530 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 99010-260 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90035-903 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90110-270 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90430-090 Brazil
  • Porto Alegre
  • Porto Alegre Rio Grande Do Sul 90610 Brazil
  • Joinville
  • Joinville Santa Catarina 89201 Brazil
  • São José Do Rio Preto
  • São José Do Rio Preto Sao Paulo 15090 Brazil
  • São Paulo
  • São Paulo 01406 Brazil
  • Calgary
  • Calgary Alberta T2V1P9 Canada
  • Vancouver
  • Vancouver British Columbia V5Z1M9 Canada
  • Halifax
  • Halifax Nova Scotia B3H2Y9 Canada
  • Hamilton
  • Hamilton Ontario L8N4A6 Canada
  • London
  • London Ontario N6A5W9 Canada
  • Montreal
  • Montréal Quebec H2X0A9 Canada
  • Sherbrooke
  • Sherbrooke Quebec J1H5N4 Canada
  • Toronto
  • Toronto Quebec H2X0A9 Canada
  • Quebec
  • Quebec Canada
  • Nanjing
  • Nanjing Jiangsu 210008 China
  • Changchun
  • Chang chun Jilin 130021 China
  • Shanghai
  • Shanghai Shanghai 020043 China
  • Taiyuan
  • Taiyuan Shanxi 030001 China
  • Beijing
  • Beijing 100041 China
  • Beijing
  • Beijing 100050 China
  • Beijing Shi
  • Beijing 100730 China
  • Chongqing
  • Chongqing 400030 China
  • Hangzhou
  • Hangzhou 31003 China
  • Lanzhou
  • Lanzhou 730030 China
  • Nanchang
  • Nanchang 330006 China
  • Shanghai
  • Shanghai 200040 China
  • Suzhou
  • Suzhou 215004 China
  • Alborg
  • Aalborg Nordjylland DK-9000 Denmark
  • Aarhus
  • Aarhus 8200 Denmark
  • Copenhagen
  • Copenhagen 2200 Denmark
  • Herlev
  • Herlev 2730 Denmark
  • Vejle
  • Vejle DK-7100 Denmark
  • Helsinki
  • Helsinki 00029 HUS Finland
  • Seinajoki
  • Seinäjoki FI-60220 Finland
  • Tampere
  • Tampere FI-33520 Finland
  • Turku
  • Turku FI-20520 Finland
  • Strasbourg
  • Strasbourg Bas-Rhin 67091 France
  • Marseille
  • Marseille Bouches-du-Rhône 13385 France
  • Lille
  • Lille Nord 59037 France
  • Pierre Benite
  • Pierre-Bénite Rhone 69495 France
  • Creteil
  • Créteil Val De Marne 94010 France
  • Creteil
  • Créteil Val-de-Marne 94010 France
  • Hyeres
  • Hyères 83400 France
  • Lyon
  • Lyon 69437 France
  • Nimes
  • Nîmes 30029 France
  • Poitiers
  • Poitiers 86021 France
  • Emmendingen
  • Emmendingen Baden-Wurttemberg 79312 Germany
  • Planegg
  • Planegg Bayern 82152 Germany
  • Braunschweig
  • Braunschweig Niedersachsen 38100 Germany
  • Braunschweig
  • Braunschweig Niedersachsen 38126 Germany
  • Dresden
  • Dresden 01307 Germany
  • Hamburg
  • Hamburg 22399 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
  • Pavia
  • Pavia 27100 Italy
  • Kanazawa-shi
  • Kanazawa-shi Isikawa 920-8641 Japan
  • Sendai
  • Sendai Miyagi 9808574 Japan
  • Sendai
  • Sendai Miyagi 9818563 Japan
  • Suita
  • Suita Osaka 565-0871 Japan
  • Osaka-sayama City
  • Ōsaka-sayama Osaka 589-8511 Japan
  • Fukuoka
  • Fukuoka 812-0033 Japan
  • Hiroshima
  • Hiroshima 730-8518 Japan
  • Hiroshima
  • Hiroshima 7308518 Japan
  • Kita-gun
  • Kita 761093 Japan
  • Kyoto
  • Kyoto 606-8507 Japan
  • Maebashi-shi
  • Maebashi 371-8511 Japan
  • Nagasaki-shi
  • Nagasaki Japan
  • Osaka
  • Osaka Japan
  • Sapporo
  • Sapporo 003-0804 Japan
  • Tokyo
  • Tokyo 285-8741 Japan
  • Tokyo
  • Tokyo Japan
  • Ube-shi
  • Ube 7558505 Japan
  • Yokohama City
  • Yokohama Japan
  • Ōsaka-sayama
  • Ōsaka-sayama Ôsaka 589-8511 Japan
  • Goyang-Si
  • Goyang-si Gyeonggido 10408 Korea, Republic of
  • Busan
  • Busan 49241 Korea, Republic of
  • Hwasun-gun
  • Hwasun 58128 Korea, Republic of
  • Hwasun-gun
  • Hwasun Korea, Republic of
  • Seongnam
  • Seongnam 13620 Korea, Republic of
  • Seoul
  • Seoul 03722 Korea, Republic of
  • Seoul
  • Seoul 05505 Korea, Republic of
  • Seoul
  • Seoul 06351 Korea, Republic of
  • Seoul
  • Seoul 135720 Korea, Republic of
  • Seoul
  • Seoul 13572 Korea, Republic of
  • Eindhoven
  • Eindhoven Noord Brabant 5623EJ Netherlands
  • Amsterdam
  • Amsterdam Noord Holland 1105AZ Netherlands
  • Maastricht
  • Maastricht 6229HX Netherlands
  • Sneek
  • Sneek 8601 ZK Netherlands
  • Hamilton
  • Hamilton Northland 3204 New Zealand
  • Dunedin
  • Dunedin South Island 9001 New Zealand
  • Canterbury
  • Christchurch 8013 New Zealand
  • Tauranga
  • Tauranga 3140 New Zealand
  • Wroclaw
  • Wrocław Dolnoslaskie 53114 Poland
  • Gdynia
  • Gdynia Lubelskie 20-582 Poland
  • Lublin
  • Lublin Lubelskie 20582 Poland
  • Siedlce
  • Siedlce Mazowieckie 08110 Poland
  • Warszawa
  • Warszawa Mazowieckie 02-797 Poland
  • Gdynia
  • Gdynia 81-519 Poland
  • Gdynia
  • Gdynia 81519 Poland
  • Katowice
  • Katowice 40611 Poland
  • Bratislava
  • Bratislava 845 05 Slovakia
  • Kosice
  • Košice 04001 Slovakia
  • Martin
  • Martin Slovakia
  • Nitra
  • Nitra 94901 Slovakia
  • Poprad
  • Poprad Slovakia
  • Presov
  • Prešov 080 01 Slovakia
  • Trencin
  • Trenčín 911 01 Slovakia
  • Sula
  • Šula 927 01 Slovakia
  • A Coruna
  • A Coruña A Coruna 15006 Spain
  • Oviedo
  • Oviedo Asturias 33011 Spain
  • Barcelona
  • Barcelona 8036 Spain
  • Barcelona
  • Barcelona Spain
  • Madrid
  • Madrid 28006 Spain
  • Madrid
  • Madrid 28041 Spain
  • Sabadell
  • Sabadell 08208 Spain
  • Salamanca
  • Salamanca 37007 Spain
  • Santiago de Compostela
  • Santiago de Compostela 15706 Spain
  • Valencia
  • Valencia 46009 Spain
  • Orebro
  • Örebro Orebro Ian SE-70185 Sweden
  • Malmo
  • Malmö Skane Ian Sweden
  • Stockholm
  • Stockholm Sodermandlands Ian Sweden
  • Stockholm
  • Stockholm Sodermanlands Ian Sweden
  • Uppsala
  • Uppsala 751 85 Sweden
  • Kaohsiung
  • Kaohsiung Taiwan
  • Taipei
  • Taipei 112 Taiwan
  • Taipei
  • Taipei 11490 Taiwan
  • Taipei
  • Taipei Taiwan
  • Wirral
  • Wirral Cheshire CH63 4JY United Kingdom
  • Glasgow
  • Glasgow Glasgow City G12 0YN United Kingdom
  • Scunthorpe
  • Scunthorpe North Lincolnshire DN157BH United Kingdom
  • Aberdeen
  • Aberdeen AB252ZN United Kingdom
  • Nottingham
  • Nottingham NG5 1PB United Kingdom
  • Plymouth
  • Plymouth PL68DH United Kingdom
  • Wrexham
  • Wrexham United Kingdom

View trial on ClinicalTrials.gov