MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

Status: Recruiting
Location: See all (314) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The main inclusion criteria include but are not limited to the following:

• Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology

• Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening

• Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)

• Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \[mHSPC\] or non-metastatic hormone-sensitive prostate cancer \[nmHSPC\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \[mCRPC\] or non-metastatic castration-resistant prostate cancer \[nmCRPC\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel

• Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment

• Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)

• Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization

• Has adequate organ function

• Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed

• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization

• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

• Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible

• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Locations
United States
Arizona
The University of Arizona Cancer Center - North Campus ( Site 0073)
ACTIVE_NOT_RECRUITING
Tucson
California
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
ACTIVE_NOT_RECRUITING
Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
RECRUITING
Orange
University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120)
RECRUITING
Orange
Stanford Cancer Center ( Site 0036)
ACTIVE_NOT_RECRUITING
Palo Alto
Emad Ibrahim,MD,INC. ( Site 0012)
COMPLETED
Redlands
Kaiser Permanente Riverside Medical Center ( Site 0099)
ACTIVE_NOT_RECRUITING
Riverside
University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)
RECRUITING
Sacramento
San Francisco VA Health Care System ( Site 0093)
ACTIVE_NOT_RECRUITING
San Francisco
Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)
ACTIVE_NOT_RECRUITING
Vallejo
Colorado
University of Colorado Anschutz Medical Campus ( Site 0046)
ACTIVE_NOT_RECRUITING
Aurora
UCHealth Highlands Ranch Hospital ( Site 0111)
ACTIVE_NOT_RECRUITING
Highlands Ranch
Colorado Clinical Research ( Site 0067)
RECRUITING
Lakewood
University of Colorado Health - Lone Tree Medical Center ( Site 0112)
ACTIVE_NOT_RECRUITING
Lone Tree
Connecticut
Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
ACTIVE_NOT_RECRUITING
New Haven
Washington, D.c.
MedStar Washington Hospital Center ( Site 0103)
RECRUITING
Washington D.c.
Florida
Florida Cancer Specialists - South ( Site 7003)
ACTIVE_NOT_RECRUITING
Fort Myers
Mount Sinai Cancer Center ( Site 0107)
ACTIVE_NOT_RECRUITING
Miami Beach
Memorial Hospital West-Memorial Cancer Institute ( Site 0109)
RECRUITING
Pembroke Pines
Georgia
Northside Hospital-Northside Hospital Oncology Network ( Site 0100)
ACTIVE_NOT_RECRUITING
Atlanta
Illinois
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
RECRUITING
Elmhurst
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
RECRUITING
Naperville
Illinois Cancer Care ( Site 0104)
RECRUITING
Peoria
Indiana
Urology of Indiana - Carmel ( Site 0055)
RECRUITING
Carmel
Kentucky
University of Kentucky Chandler Medical Center ( Site 0048)
ACTIVE_NOT_RECRUITING
Lexington
Maryland
Baltimore Veterans Affairs Medical Center ( Site 0069)
RECRUITING
Baltimore
Greenebaum Comprehensive Cancer Center ( Site 0049)
RECRUITING
Baltimore
Chesapeake Urology ( Site 0009)
RECRUITING
Towson
Michigan
Henry Ford Hospital ( Site 0015)
ACTIVE_NOT_RECRUITING
Detroit
Cancer and Hematology Centers of Western Michigan ( Site 0005)
RECRUITING
Grand Rapids
Minnesota
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
ACTIVE_NOT_RECRUITING
Saint Louis Park
HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
ACTIVE_NOT_RECRUITING
Saint Paul
Montana
St. Vincent Frontier Cancer Center-Research ( Site 0037)
RECRUITING
Billings
Nebraska
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
RECRUITING
Omaha
New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0033)
RECRUITING
New Brunswick
Nevada
Comprehensive Cancer Centers of Nevada ( Site 0010)
RECRUITING
Las Vegas
OptumCare Cancer Care-Research Department ( Site 0078)
RECRUITING
Las Vegas
New York
Associated Medical Professionals - Urology ( Site 0081)
RECRUITING
Syracuse
Ohio
University Hospitals Cleveland Medical Center ( Site 0043)
ACTIVE_NOT_RECRUITING
Cleveland
Central Ohio Urology Group - Gahanna ( Site 0098)
ACTIVE_NOT_RECRUITING
Gahanna
Genesis Healthcare System ( Site 0102)
ACTIVE_NOT_RECRUITING
Zanesville
Pennsylvania
MidLantic urology ( Site 0022)
RECRUITING
Bala-cynwyd
Fox Chase Cancer Center ( Site 0076)
ACTIVE_NOT_RECRUITING
Philadelphia
South Carolina
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
RECRUITING
Charleston
South Dakota
Avera Cancer Institute - Pierre ( Site 0118)
ACTIVE_NOT_RECRUITING
Pierre
Avera Cancer Institute- Research ( Site 0094)
ACTIVE_NOT_RECRUITING
Sioux Falls
Avera Cancer Institute - Yankton ( Site 0117)
ACTIVE_NOT_RECRUITING
Yankton
Tennessee
The West Clinic, PLLC dba West Cancer Center ( Site 0063)
ACTIVE_NOT_RECRUITING
Germantown
Texas
Texas Oncology - Central/South Texas ( Site 8003)
ACTIVE_NOT_RECRUITING
Austin
Texas Oncology - DFW ( Site 8001)
ACTIVE_NOT_RECRUITING
Dallas
Texas Oncology - Gulf Coast ( Site 8002)
ACTIVE_NOT_RECRUITING
Houston
Virginia
University of Virginia Health System ( Site 0054)
RECRUITING
Charlottesville
Inova Schar Cancer Institute ( Site 0017)
RECRUITING
Fairfax
Virginia Cancer Specialists (VCS) ( Site 8004)
ACTIVE_NOT_RECRUITING
Fairfax
VCU Health Adult Outpatient Pavillion ( Site 0061)
RECRUITING
Richmond
Blue Ridge Cancer Care ( Site 0004)
RECRUITING
Roanoke
Washington
Spokane Urology ( Site 0035)
RECRUITING
Spokane
Northwest Cancer Specialists (Compass Oncology) ( Site 8008)
ACTIVE_NOT_RECRUITING
Vancouver
Wisconsin
MEDICAL COLLEGE OF WISCONSIN ( Site 0020)
RECRUITING
Milwaukee
Other Locations
Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)
ACTIVE_NOT_RECRUITING
Brisbane
Monash Health ( Site 0219)
ACTIVE_NOT_RECRUITING
Clayton
Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)
ACTIVE_NOT_RECRUITING
Macquarie University
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)
ACTIVE_NOT_RECRUITING
Melbourne
Westmead Hospital ( Site 0212)
ACTIVE_NOT_RECRUITING
Westmead
Brazil
Hospital Mario Penna ( Site 0264)
ACTIVE_NOT_RECRUITING
Belo Horizonte
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)
ACTIVE_NOT_RECRUITING
Bragança Paulista
Hospital Universitário Evangélico Mackenzie ( Site 0252)
ACTIVE_NOT_RECRUITING
Curitiba
ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)
ACTIVE_NOT_RECRUITING
Curitiba
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)
ACTIVE_NOT_RECRUITING
Fortaleza
Clínica de Neoplasias Litoral ( Site 0269)
ACTIVE_NOT_RECRUITING
Itajaí
Hospital São Lucas da PUCRS ( Site 0270)
ACTIVE_NOT_RECRUITING
Porto Alegre
Obras Sociais Irma Dulce ( Site 0255)
ACTIVE_NOT_RECRUITING
Salvador
Hospital de Base de São José do Rio Preto ( Site 0275)
ACTIVE_NOT_RECRUITING
São José Do Rio Preto
Hospital São Domingos ( Site 0258)
ACTIVE_NOT_RECRUITING
São Luís
Hospital Paulistano ( Site 0259)
ACTIVE_NOT_RECRUITING
São Paulo
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)
ACTIVE_NOT_RECRUITING
Taubaté
Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)
ACTIVE_NOT_RECRUITING
Uberaba
Hospital Santa Rita de Cassia ( Site 0271)
ACTIVE_NOT_RECRUITING
Vitória
Canada
Trillium Health Partners - Credit Valley Hospital ( Site 0289)
ACTIVE_NOT_RECRUITING
Mississauga
Centre Hospitalier de l'Université de Montréal ( Site 0276)
ACTIVE_NOT_RECRUITING
Montreal
The Ottawa Hospital - General Campus ( Site 0286)
ACTIVE_NOT_RECRUITING
Ottawa
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)
ACTIVE_NOT_RECRUITING
Québec
Sunnybrook Research Institute ( Site 0285)
ACTIVE_NOT_RECRUITING
Toronto
Chile
Bradfordhill-Clinical Area ( Site 0301)
ACTIVE_NOT_RECRUITING
Santiago
FALP ( Site 0303)
ACTIVE_NOT_RECRUITING
Santiago
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)
ACTIVE_NOT_RECRUITING
Santiago
Clinica Universidad Catolica del Maule-Oncology ( Site 0306)
ACTIVE_NOT_RECRUITING
Talca
CIDO SpA-Oncology ( Site 0302)
ACTIVE_NOT_RECRUITING
Temuco
ONCOCENTRO APYS-ACEREY ( Site 0305)
ACTIVE_NOT_RECRUITING
Viña Del Mar
China
Beijing Cancer Hospital ( Site 1623)
ACTIVE_NOT_RECRUITING
Beijing
Beijing Cancer hospital-Urinary Surgery ( Site 1620)
ACTIVE_NOT_RECRUITING
Beijing
First Medical Center of Chinese PLA General Hospital ( Site 1601)
ACTIVE_NOT_RECRUITING
Beijing
Peking University First Hospital-Urology ( Site 1602)
RECRUITING
Beijing
Hunan Cancer Hospital ( Site 1630)
ACTIVE_NOT_RECRUITING
Changsha
West China Hospital, Sichuan University-Urology Surgery ( Site 1642)
ACTIVE_NOT_RECRUITING
Chengdu
Chongqing University Cancer Hospital ( Site 1603)
ACTIVE_NOT_RECRUITING
Chongqing
Southwest Hospital of Third Military Medical University ( Site 1645)
ACTIVE_NOT_RECRUITING
Chongqing
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)
ACTIVE_NOT_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)
ACTIVE_NOT_RECRUITING
Guangzhou
The first affiliated hospital of Guangzhou medical university ( Site 1637)
ACTIVE_NOT_RECRUITING
Guangzhou
Zhejiang Provincial People's Hospital-Urology ( Site 1641)
ACTIVE_NOT_RECRUITING
Hangzhou
The Second Hospital Of Anhui Medical University ( Site 1633)
ACTIVE_NOT_RECRUITING
Hefei
The First Hospital of Jiaxing-urology ( Site 1605)
ACTIVE_NOT_RECRUITING
Jiaxing
Yunnan Province Cancer Hospital ( Site 1643)
ACTIVE_NOT_RECRUITING
Kunming
Nanchong Central Hospital-urology ( Site 1647)
RECRUITING
Nanchong
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)
ACTIVE_NOT_RECRUITING
Nanjing
Nantong Tumor Hospital-Urology ( Site 1609)
ACTIVE_NOT_RECRUITING
Nantong
Ningbo First Hospital-Urology ( Site 1608)
ACTIVE_NOT_RECRUITING
Ningbo
Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)
ACTIVE_NOT_RECRUITING
Shanghai
Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)
ACTIVE_NOT_RECRUITING
Shanghai
The Second Hospital of Tianjin Medical University ( Site 1616)
ACTIVE_NOT_RECRUITING
Tianjin
Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)
ACTIVE_NOT_RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)
ACTIVE_NOT_RECRUITING
Wenzhou
Hubei Cancer Hospital-Urinary surgery ( Site 1631)
ACTIVE_NOT_RECRUITING
Wuhan
The Central Hospital of Wuhan ( Site 1635)
ACTIVE_NOT_RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)
ACTIVE_NOT_RECRUITING
Wuhan
Wuxi People's Hospital ( Site 1612)
ACTIVE_NOT_RECRUITING
Wuxi
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)
ACTIVE_NOT_RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)
ACTIVE_NOT_RECRUITING
Xi'an
Yantai Yuhuangding Hospital ( Site 1622)
ACTIVE_NOT_RECRUITING
Yantai
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)
ACTIVE_NOT_RECRUITING
Bogotá
Los Cobos Medical Center ( Site 0336)
ACTIVE_NOT_RECRUITING
Bogotá
Clínica Imbanaco S.A.S ( Site 0334)
ACTIVE_NOT_RECRUITING
Cali
Fundación Valle del Lili ( Site 0330)
ACTIVE_NOT_RECRUITING
Cali
IMAT S.A.S ( Site 0329)
ACTIVE_NOT_RECRUITING
Montería
Fundación Cardiovascular de Colombia ( Site 0328)
ACTIVE_NOT_RECRUITING
Piedecuesta
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)
ACTIVE_NOT_RECRUITING
Valledupar
Costa Rica
CIMCA-Hemato-Oncology ( Site 0380)
ACTIVE_NOT_RECRUITING
San José
Onco Tech, S.A. ( Site 0376)
ACTIVE_NOT_RECRUITING
San José
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)
ACTIVE_NOT_RECRUITING
Santa Ana
Estonia
East-Tallinn Central Hospital ( Site 1528)
ACTIVE_NOT_RECRUITING
Tallinn
North Estonia Medical Centre Foundation ( Site 1526)
ACTIVE_NOT_RECRUITING
Tallinn
Tartu University Hospital-Radiotherapy and oncology ( Site 1527)
ACTIVE_NOT_RECRUITING
Tartu
France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)
ACTIVE_NOT_RECRUITING
Avignon
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)
ACTIVE_NOT_RECRUITING
Bordeaux
CHU-BREST Cavale Blanche ( Site 0456)
ACTIVE_NOT_RECRUITING
Brest
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)
ACTIVE_NOT_RECRUITING
Clermont-ferrand
Centre Bourgogne ( Site 0464)
ACTIVE_NOT_RECRUITING
Lille
CENTRE LEON BERARD ( Site 0459)
ACTIVE_NOT_RECRUITING
Lyon Cedex08
Groupe Hospitalier Paris Saint Joseph ( Site 0465)
ACTIVE_NOT_RECRUITING
Paris
Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)
ACTIVE_NOT_RECRUITING
Quint-fonsegrives
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451)
ACTIVE_NOT_RECRUITING
Strasbourg
Hôpital Foch ( Site 0455)
ACTIVE_NOT_RECRUITING
Suresnes
Gustave Roussy ( Site 0452)
ACTIVE_NOT_RECRUITING
Villejuif
Germany
Marien-Krankenhaus ( Site 0515)
ACTIVE_NOT_RECRUITING
Bergisch Gladbach
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)
ACTIVE_NOT_RECRUITING
Berlin
Vivantes Klinikum Am Urban ( Site 0512)
ACTIVE_NOT_RECRUITING
Berlin
Universitaetsklinikum Koeln ( Site 0518)
ACTIVE_NOT_RECRUITING
Cologne
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)
COMPLETED
Dresden
Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)
ACTIVE_NOT_RECRUITING
Freiburg Im Breisgau
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)
ACTIVE_NOT_RECRUITING
Göttingen
Universitaetsklinikum Heidelberg ( Site 0531)
ACTIVE_NOT_RECRUITING
Heidelberg
Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)
COMPLETED
Marburg
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)
ACTIVE_NOT_RECRUITING
Munich
Studienpraxis Urologie ( Site 0529)
ACTIVE_NOT_RECRUITING
Nürtingen
Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)
ACTIVE_NOT_RECRUITING
Regensburg
Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)
ACTIVE_NOT_RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)
ACTIVE_NOT_RECRUITING
Chaïdári
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)
ACTIVE_NOT_RECRUITING
Pátrai
Guatemala
CELAN,S.A ( Site 0579)
RECRUITING
Guatemala City
INTEGRA Cancer Institute-Oncology ( Site 0578)
RECRUITING
Guatemala City
MEDI-K ( Site 0576)
RECRUITING
Guatemala City
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)
RECRUITING
Guatemala City
Sanatorio Nuestra Senora del Pilar ( Site 0580)
RECRUITING
Guatemala City
Hong Kong Special Administrative Region
Hong Kong Integrated Oncology Centre ( Site 0603)
ACTIVE_NOT_RECRUITING
Central
Queen Mary Hospital ( Site 0602)
ACTIVE_NOT_RECRUITING
Hong Kong
Hungary
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)
ACTIVE_NOT_RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)
ACTIVE_NOT_RECRUITING
Debrecen
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)
ACTIVE_NOT_RECRUITING
Miskolc
Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)
ACTIVE_NOT_RECRUITING
Salgótarján
Ireland
St. Vincent's University Hospital ( Site 0652)
ACTIVE_NOT_RECRUITING
Dublin
Tallaght University Hospital ( Site 0651)
ACTIVE_NOT_RECRUITING
Dublin
Israel
Emek Medical Center ( Site 0680)
ACTIVE_NOT_RECRUITING
Afula
Rambam Health Care Campus-Oncology Division ( Site 0676)
ACTIVE_NOT_RECRUITING
Haifa
Hadassah Medical Center ( Site 0683)
ACTIVE_NOT_RECRUITING
Jerusalem
Shaare Zedek Medical Center ( Site 0679)
ACTIVE_NOT_RECRUITING
Jerusalem
Meir Medical Center. ( Site 0682)
ACTIVE_NOT_RECRUITING
Kfar Saba
Rabin Medical Center ( Site 0678)
ACTIVE_NOT_RECRUITING
Petah Tikva
Sheba Medical Center ( Site 0677)
ACTIVE_NOT_RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 0681)
ACTIVE_NOT_RECRUITING
Tel Aviv
Italy
Ospedale Cannizzaro ( Site 1455)
ACTIVE_NOT_RECRUITING
Catania
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)
ACTIVE_NOT_RECRUITING
Foggia
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 1454)
ACTIVE_NOT_RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)
ACTIVE_NOT_RECRUITING
Milan
Ospedale San Raffaele-Oncologia Medica ( Site 1451)
ACTIVE_NOT_RECRUITING
Milan
Azienda Ospedaliera Santa Maria Terni ( Site 1458)
ACTIVE_NOT_RECRUITING
Terni
Japan
Akita University Hospital ( Site 0728)
ACTIVE_NOT_RECRUITING
Akita
University of Fukui Hospital ( Site 0735)
ACTIVE_NOT_RECRUITING
Eiheiji-cho,yoshida-gun
Kyushu University Hospital ( Site 0745)
ACTIVE_NOT_RECRUITING
Fukuoka
Fukushima Medical University Hospital ( Site 0758)
ACTIVE_NOT_RECRUITING
Fukushima
Gifu University Hospital ( Site 0736)
ACTIVE_NOT_RECRUITING
Gifu
Kansai Medical University Hospital ( Site 0739)
ACTIVE_NOT_RECRUITING
Hirakata
Hiroshima University Hospital ( Site 0743)
ACTIVE_NOT_RECRUITING
Hiroshima
Nihon University Itabashi Hospital ( Site 0732)
COMPLETED
Itabashiku
Kagoshima University Hospital ( Site 0754)
ACTIVE_NOT_RECRUITING
Kagoshima
Nara Medical University Hospital ( Site 0742)
ACTIVE_NOT_RECRUITING
Kashihara
Kagawa University Hospital ( Site 0744)
ACTIVE_NOT_RECRUITING
Kita
Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)
ACTIVE_NOT_RECRUITING
Kitakyushu
Kobe University Hospital ( Site 0741)
ACTIVE_NOT_RECRUITING
Kobe
National Hospital Organization Kumamoto Medical Center ( Site 0749)
ACTIVE_NOT_RECRUITING
Kumamoto
The Jikei University Hospital ( Site 0731)
ACTIVE_NOT_RECRUITING
Minato
Miyazaki Prefectural Miyazaki Hospital ( Site 0752)
ACTIVE_NOT_RECRUITING
Miyazaki
University of Miyazaki Hospital ( Site 0751)
ACTIVE_NOT_RECRUITING
Miyazaki
Kanazawa Medical University Hospital ( Site 0734)
ACTIVE_NOT_RECRUITING
Mukai-awagasaki
Nagano Municipal Hospital ( Site 0757)
ACTIVE_NOT_RECRUITING
Nagano
National Hospital Organization Oita Medical Center ( Site 0750)
COMPLETED
Ōita
National Hospital Organization Nagasaki Medical Center ( Site 0748)
ACTIVE_NOT_RECRUITING
Ōmura
Saga-Ken Medical Centre Koseikan ( Site 0747)
ACTIVE_NOT_RECRUITING
Saga
Bell Land General Hospital ( Site 0740)
ACTIVE_NOT_RECRUITING
Sakai
Toho University Sakura Medical Center ( Site 0730)
ACTIVE_NOT_RECRUITING
Sakura
Hokkaido University Hospital ( Site 0756)
ACTIVE_NOT_RECRUITING
Sapporo
Sapporo Medical University Hospital ( Site 0726)
ACTIVE_NOT_RECRUITING
Sapporo
Nanbu Tokushukai Hospital ( Site 0755)
ACTIVE_NOT_RECRUITING
Shimajiri
The University of Osaka Hospital ( Site 0738)
ACTIVE_NOT_RECRUITING
Suita
Mie University Hospital ( Site 0737)
ACTIVE_NOT_RECRUITING
Tsu
Yokohama City University Medical Center ( Site 0733)
ACTIVE_NOT_RECRUITING
Yokohama
Latvia
Liepaja Regional Hospital ( Site 1553)
ACTIVE_NOT_RECRUITING
Liepāja
Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)
ACTIVE_NOT_RECRUITING
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)
ACTIVE_NOT_RECRUITING
Kaunas
National Cancer Institute ( Site 1577)
ACTIVE_NOT_RECRUITING
Vilnius
Malaysia
Hospital Sultan Ismail ( Site 0905)
ACTIVE_NOT_RECRUITING
Johor Bahru
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Sarawak General Hospital-Radiotherapy Unit ( Site 0901)
ACTIVE_NOT_RECRUITING
Kuching
University Malaya Medical Centre ( Site 0902)
ACTIVE_NOT_RECRUITING
Lembah Pantai
National Cancer Institute ( Site 0904)
COMPLETED
Putrajaya
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928)
ACTIVE_NOT_RECRUITING
Guadalajara
Health Pharma Professional Research S.A. de C.V: ( Site 0929)
ACTIVE_NOT_RECRUITING
Mexico City
Higiea Oncologia ( Site 0938)
ACTIVE_NOT_RECRUITING
Mexico City
Eukarya Pharmasite S.C. ( Site 0939)
ACTIVE_NOT_RECRUITING
Monterrey
Filios Alta Medicina ( Site 0931)
ACTIVE_NOT_RECRUITING
Monterrey
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Servicio de Oncología ( Site 0932)
ACTIVE_NOT_RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0934)
ACTIVE_NOT_RECRUITING
Oaxaca City
Quemex Medical and Research ( Site 0937)
ACTIVE_NOT_RECRUITING
Tlalpan
New Zealand
Auckland City Hospital ( Site 1033)
ACTIVE_NOT_RECRUITING
Auckland
Dunedin Hospital ( Site 1032)
COMPLETED
Dunedin
Peru
Aliada-Oncologìa ( Site 1055)
ACTIVE_NOT_RECRUITING
Lima
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)
ACTIVE_NOT_RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)
ACTIVE_NOT_RECRUITING
Lima
Oncosalud-Clinical Research ( Site 1057)
ACTIVE_NOT_RECRUITING
Lima
Portugal
Hospital de Cascais Doutor José de Almeida ( Site 1158)
ACTIVE_NOT_RECRUITING
Alcabideche
Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)
ACTIVE_NOT_RECRUITING
Braga
Hospital CUF - Tejo ( Site 1157)
ACTIVE_NOT_RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)
ACTIVE_NOT_RECRUITING
Lisbon
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)
ACTIVE_NOT_RECRUITING
Porto
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)
ACTIVE_NOT_RECRUITING
Vila Nova De Gaia
Puerto Rico
Ad-Vance Medical Research-Research ( Site 1177)
RECRUITING
Ponce
Advance Urology and Laparoscopic Center ( Site 1178)
COMPLETED
Ponce
Pan American Center for Oncology Trials - Ciudadela ( Site 1176)
RECRUITING
San Juan
Republic of Korea
Kyungpook National University Chilgok Hospital-Urology ( Site 1252)
ACTIVE_NOT_RECRUITING
Buk-gu
National Cancer Center-Center for Urologic Cancer ( Site 1254)
ACTIVE_NOT_RECRUITING
Goyang-si
Pusan National University Yangsan Hospital ( Site 1256)
ACTIVE_NOT_RECRUITING
Pusan
Seoul National University Bundang Hospital-Urology ( Site 1253)
ACTIVE_NOT_RECRUITING
Seongnam
Seoul National University Hospital-Urology ( Site 1251)
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)
ACTIVE_NOT_RECRUITING
Seoul
Romania
Spitalul Universitar de Urgență Elias ( Site 1504)
ACTIVE_NOT_RECRUITING
Bucharest
Cardiomed SRL Cluj-Napoca ( Site 1503)
ACTIVE_NOT_RECRUITING
Cluj-napoca
Centrul de Oncologie Sfântul Nectarie ( Site 1501)
ACTIVE_NOT_RECRUITING
Craiova
SC Radiotherapy Center Cluj SRL ( Site 1502)
ACTIVE_NOT_RECRUITING
Florești
Singapore
National Cancer Centre Singapore ( Site 1202)
RECRUITING
Singapore
National University Hospital ( Site 1201)
RECRUITING
Singapore
Singapore General Hospital ( Site 1204)
RECRUITING
Singapore
Tan Tock Seng Hospital-Medical Oncology ( Site 1203)
RECRUITING
Singapore
Slovakia
UROEXAM ( Site 1479)
ACTIVE_NOT_RECRUITING
Nitra
Privatna Urologicka Ambulancia ( Site 1478)
ACTIVE_NOT_RECRUITING
Trenčín
South Africa
Cape Town Oncology Trials ( Site 1233)
COMPLETED
Cape Town
Wits Clinical Research ( Site 1234)
ACTIVE_NOT_RECRUITING
Johannesburg
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)
ACTIVE_NOT_RECRUITING
Port Elizabeth
Curo Oncology. ( Site 1237)
ACTIVE_NOT_RECRUITING
Pretoria
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)
ACTIVE_NOT_RECRUITING
Pretoria
Wilgers Oncology Centre ( Site 1232)
ACTIVE_NOT_RECRUITING
Pretoria
Spain
Complexo Hospitalario Universitario A Coruna ( Site 1288)
ACTIVE_NOT_RECRUITING
A Coruña
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario de Burgos-Oncología ( Site 1281)
ACTIVE_NOT_RECRUITING
Burgos
Institut Català d'Oncologia (ICO) - Girona ( Site 1285)
ACTIVE_NOT_RECRUITING
Girona
Hospital Insular de Gran Canaria-Oncology ( Site 1280)
ACTIVE_NOT_RECRUITING
Las Palmas De Gran Canaria
Hospital Quirón Málaga ( Site 1286)
ACTIVE_NOT_RECRUITING
Málaga
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)
ACTIVE_NOT_RECRUITING
Pozuelo De Alarcón
Hospital Universitari Parc Tauli-oncologia ( Site 1282)
ACTIVE_NOT_RECRUITING
Sabadell
Sweden
Karolinska Universitetssjukhuset Solna ( Site 1302)
ACTIVE_NOT_RECRUITING
Stockholm
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)
ACTIVE_NOT_RECRUITING
Uppsala
Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)
ACTIVE_NOT_RECRUITING
Kaohsiung City
Kaohsiung Veterans General Hospital ( Site 1337)
ACTIVE_NOT_RECRUITING
Kaohsiung City
China Medical University Hospital-Department of Urology ( Site 1335)
ACTIVE_NOT_RECRUITING
Taichung
Taichung Veterans General Hospital ( Site 1338)
ACTIVE_NOT_RECRUITING
Taichung
Chi Mei Medical Center ( Site 1336)
ACTIVE_NOT_RECRUITING
Tainan
Taipei Veterans General Hospital ( Site 1332)
ACTIVE_NOT_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)
ACTIVE_NOT_RECRUITING
Taoyuan District
Thailand
Chulalongkorn University ( Site 1355)
ACTIVE_NOT_RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital ( Site 1356)
ACTIVE_NOT_RECRUITING
Bangkok
Songklanagarind hospital ( Site 1352)
ACTIVE_NOT_RECRUITING
Hat Yai
Faculty of Medicine - Khon Kaen University ( Site 1351)
ACTIVE_NOT_RECRUITING
Muang
Maharaj Nakorn Chiang Mai Hospital ( Site 1353)
ACTIVE_NOT_RECRUITING
Muang
Turkey
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379)
ACTIVE_NOT_RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)
ACTIVE_NOT_RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)
ACTIVE_NOT_RECRUITING
Ankara
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)
ACTIVE_NOT_RECRUITING
Istanbul
Koc Universitesi Hastanesi ( Site 1384)
ACTIVE_NOT_RECRUITING
Istanbul
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)
ACTIVE_NOT_RECRUITING
Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378)
ACTIVE_NOT_RECRUITING
Istanbul
Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)
ACTIVE_NOT_RECRUITING
Izmir
Samsun Medical Park Hastanesi-medical oncology ( Site 1382)
ACTIVE_NOT_RECRUITING
Samsun
United Kingdom
Addenbrooke's Hospital ( Site 1426)
ACTIVE_NOT_RECRUITING
Cambridge
Royal Derby Hospital ( Site 1431)
ACTIVE_NOT_RECRUITING
Derby
The Beatson West of Scotland Cancer Centre ( Site 1428)
ACTIVE_NOT_RECRUITING
Glasgow
Charing Cross Hospital-Oncology Research ( Site 1434)
ACTIVE_NOT_RECRUITING
London
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
ACTIVE_NOT_RECRUITING
London
St. George's Hospital-Oncology ( Site 1441)
COMPLETED
London
University College London Hospital ( Site 1437)
ACTIVE_NOT_RECRUITING
London
The Christie NHS Foundation Trust ( Site 1436)
ACTIVE_NOT_RECRUITING
Manchester
Mount Vernon Cancer Centre ( Site 1440)
ACTIVE_NOT_RECRUITING
Northwood
GenesisCare - Oxford ( Site 1442)
ACTIVE_NOT_RECRUITING
Oxford
Torbay Hospital ( Site 1429)
ACTIVE_NOT_RECRUITING
Torquay
The Royal Cornwall Hospital ( Site 1430)
ACTIVE_NOT_RECRUITING
Truro
GenesisCare - Windsor ( Site 1443)
ACTIVE_NOT_RECRUITING
Windsor
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2030-12-02
Participants
Target number of participants: 1314
Treatments
Experimental: Hormone Replacement Therapy (HRT) + Opevesostat
Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) will also be provided to participants for use as rescue medication.
Active_comparator: Alternative Next-Generation Hormonal Agent (NHA)
Participants receive abiraterone 1000mg QD by oral tablets plus prednisone 5 mg BID by oral tablets or enzalutamide 160 mg QD by oral tablets until disease progression.
Sponsors
Collaborators: Orion Corporation, Orion Pharma
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov