Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 3NCT06136650
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
A Phase 3 study testing Opevesostat, Dexamethasone and Fludrocortisone acetate in people with Metastatic Castration-resistant Prostate Cancer (mCRPC) and Prostatic Neoplasms, run by Merck Sharp & Dohme LLC at 330 sites in 39 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
- What is being tested?
- Opevesostat, Dexamethasone and Fludrocortisone acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,314 participants
- Where
- 330 sitesin 39 countries
- Study dates
- 18 Dec 2023to 2 Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 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)
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has presence of gastrointestinal condition
- Is unable to swallow capsules/tablets
- Has history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level
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- Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) <110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
- Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
- History or family history of long QTc syndrome
- Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
- Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
- Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
- Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
- Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
- Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
- Active infection requiring systemic therapy
- Has concurrent active Hepatitis B virus and Hepatitis C virus infection
Trial locations and contacts
330 sites in 39 countries. Contact the study team or a site near you to ask about taking part.
330 sites in 39 countries
United States63 sites, 53 recruiting
- Recruiting
Avera Cancer Institute - Aberdeen ( Site 0123)
Aberdeen, South Dakota, 57401
Study Coordinator, 605-601-1830
- Recruiting
Northside Hospital-Northside Hospital Oncology Network ( Site 0100)
Atlanta, Georgia, 30342
Study Coordinator, 770-590-8311
- Recruiting
University of Colorado Anschutz Medical Campus ( Site 0046)
Aurora, Colorado, 80045
Study Coordinator, 302-290-3598
- Recruiting
Texas Oncology - Central/South Texas ( Site 8003)
Austin, Texas, 78731
Study Coordinator, 512-427-9400
- Recruiting
MidLantic urology ( Site 0022)
Bala-Cynwyd, Pennsylvania, 19004
Study Coordinator, 610-667-3020
- Recruiting
Baltimore Veterans Affairs Medical Center ( Site 0069)
Baltimore, Maryland, 21201
Study Coordinator, 1-410-7074-011
- Recruiting
Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, Maryland, 21201
Study Coordinator, 410-707-4011
- Recruiting
St. Vincent Frontier Cancer Center-Research ( Site 0037)
Billings, Montana, 59102
Study Coordinator, 406-238-6685
- Recruiting
Urology of Indiana - Carmel ( Site 0055)
Carmel, Indiana, 46032
Study Coordinator, 317-564-5158
- Recruiting
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)
Charleston, South Carolina, 29401
Study Coordinator, 843-792-7888
- Recruiting
University of Virginia Health System ( Site 0054)
Charlottesville, Virginia, 22908
Study Coordinator, 434-327-3029
- Recruiting
University Hospitals Cleveland Medical Center ( Site 0043)
Cleveland, Ohio, 44106
Study Coordinator, 216-844-3951
- Completed
Cancer Clinics of North Texas ( Site 0077)
Dallas, Texas, 75243
- Recruiting
Texas Oncology - DFW ( Site 8001)
Dallas, Texas, 75246
Study Coordinator, 214-370-1000
- Recruiting
Henry Ford Hospital ( Site 0015)
Detroit, Michigan, 48202
Study Coordinator, 313-916-1784
- Completed
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074)
Elmhurst, Illinois, 60126
- Recruiting
Inova Schar Cancer Institute ( Site 0017)
Fairfax, Virginia, 22031
Study Coordinator, 571-472-1180
- Recruiting
Virginia Cancer Specialists (VCS) ( Site 8004)
Fairfax, Virginia, 22031
Study Coordinator, 844-482-4812
- Active, not recruiting
Florida Cancer Specialists - South ( Site 7003)
Fort Myers, Florida, 33901
- Completed
Central Ohio Urology Group - Gahanna ( Site 0098)
Gahanna, Ohio, 43230
- Recruiting
The West Clinic, PLLC dba West Cancer Center ( Site 0063)
Germantown, Tennessee, 38138
Study Coordinator, 901-683-0055
- Recruiting
Cancer and Hematology Centers of Western Michigan ( Site 0005)
Grand Rapids, Michigan, 49503
Study Coordinator, 616-399-6500
- Recruiting
UCHealth Highlands Ranch Hospital ( Site 0111)
Highlands Ranch, Colorado, 80129
Study Coordinator, 720-516-1000
- Recruiting
Texas Oncology - Gulf Coast ( Site 8002)
Houston, Texas, 77024
Study Coordinator, 713-467-1722
- Recruiting
CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 0120)
Irvine, California, 92612
Study Coordinator, 714-456-7890
- Recruiting
Colorado Clinical Research ( Site 0067)
Lakewood, Colorado, 80228
Study Coordinator, 303-885-9828
- Recruiting
OptumCare Cancer Care-Research Department ( Site 0078)
Las Vegas, Nevada, 89102
Study Coordinator, 702-724-8787
- Recruiting
Comprehensive Cancer Centers of Nevada ( Site 0010)
Las Vegas, Nevada, 89148
Study Coordinator, 702-952-3449
- Active, not recruiting
University of Kentucky Chandler Medical Center ( Site 0048)
Lexington, Kentucky, 40536
- Recruiting
University of Colorado Health - Lone Tree Medical Center ( Site 0112)
Lone Tree, Colorado, 80124
Study Coordinator, 720-470-9107
- Recruiting
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
Los Angeles, California, 90404
Study Coordinator, 310-210-9001
- Recruiting
Avera Cancer Institute - Marshall ( Site 0122)
Marshall, Minnesota, 56258
Study Coordinator, 605-601-1830
- Recruiting
Mount Sinai Braman Comprehensive Cancer Center ( Site 0107)
Miami Beach, Florida, 33140
Study Coordinator, 305-535-3300
- Recruiting
Medical College of Wisconsin ( Site 0020)
Milwaukee, Wisconsin, 53226
Study Coordinator, 414-805-6700
- Recruiting
Avera Cancer Institute - Mitchell ( Site 0121)
Mitchell, South Dakota, 57301
Study Coordinator, 605-601-1830
- Completed
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075)
Naperville, Illinois, 60540
- Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0033)
New Brunswick, New Jersey, 08903
Study Coordinator, 732-235-2465
- Recruiting
Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)
New Haven, Connecticut, 06510
Study Coordinator, 203-737-8076
- Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
Omaha, Nebraska, 68130
Study Coordinator, 402-334-4773
- Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)
Orange, California, 92868
Study Coordinator, 714-456-7890
- Recruiting
Stanford Cancer Center ( Site 0036)
Palo Alto, California, 94304
Study Coordinator, 650-725-2078
- Recruiting
Memorial Hospital West-Memorial Cancer Institute ( Site 0109)
Pembroke Pines, Florida, 33028
Study Coordinator, 954-265-4325
- Recruiting
Illinois Cancer Care ( Site 0104)
Peoria, Illinois, 61615
Study Coordinator, 309-240-6388
- Recruiting
Fox Chase Cancer Center ( Site 0076)
Philadelphia, Pennsylvania, 19111
Study Coordinator, 267-512-1098
- Recruiting
Avera Cancer Institute - Pierre ( Site 0118)
Pierre, South Dakota, 57501
Study Coordinator, 605-224-3370
- Completed
Emad Ibrahim,MD,INC. ( Site 0012)
Redlands, California, 92373
- Recruiting
VCU Health Adult Outpatient Pavillion ( Site 0061)
Richmond, Virginia, 23219
Study Coordinator, 804-628-6430
- Recruiting
Kaiser Permanente Riverside Medical Center ( Site 0099)
Riverside, California, 92505
Study Coordinator, 951-353-3323
- Recruiting
Blue Ridge Cancer Care ( Site 0004)
Roanoke, Virginia, 24014
Study Coordinator, 540-982-0237
- Recruiting
University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114)
Sacramento, California, 95817
Study Coordinator, 916-734-3772
- Recruiting
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072)
Saint Louis Park, Minnesota, 55426
Study Coordinator, 952-977-5555
- Recruiting
HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092)
Saint Paul, Minnesota, 55101
Study Coordinator, 651-254-1517
- Recruiting
San Francisco VA Health Care System ( Site 0093)
San Francisco, California, 94121
Study Coordinator, 415-221-4810 x23022
- Recruiting
Avera Cancer Institute- Research ( Site 0094)
Sioux Falls, South Dakota, 57105
Study Coordinator, 605-322-6900
- Recruiting
Spokane Urology ( Site 0035)
Spokane, Washington, 99202
Study Coordinator, 509-747-3147
- Recruiting
Associated Medical Professionals - Urology ( Site 0081)
Syracuse, New York, 13210
Study Coordinator, 315-478-4185
- Recruiting
Chesapeake Urology ( Site 0009)
Towson, Maryland, 21204
Study Coordinator, 410-825-5454
- Recruiting
The University of Arizona Cancer Center - North Campus ( Site 0073)
Tucson, Arizona, 85719
Study Coordinator, 520-626-1068
- Active, not recruiting
Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101)
Vallejo, California, 94589
- Active, not recruiting
Northwest Cancer Specialists (Compass Oncology) ( Site 8008)
Vancouver, Washington, 98684
- Recruiting
MedStar Washington Hospital Center ( Site 0103)
Washington D.C., District of Columbia, 20010
Study Coordinator, 202-877-6583
- Recruiting
Avera Cancer Institute - Yankton ( Site 0117)
Yankton, South Dakota, 57078
Study Coordinator, 605-655-1800
- Completed
Genesis Healthcare System ( Site 0102)
Zanesville, Ohio, 43701
China31 sites, 31 recruiting
- Recruiting
Peking University First Hospital-Urology ( Site 1602)
Beijing, Beijing Municipality, 100034
Study Coordinator, 13910688432
- Recruiting
Beijing Cancer hospital-Urinary Surgery ( Site 1620)
Beijing, Beijing Municipality, 100142
Study Coordinator, 86 010 8812 1122
- Recruiting
First Medical Center of Chinese PLA General Hospital ( Site 1601)
Beijing, Beijing Municipality, 100853
Study Coordinator, 13693556315
- Recruiting
Beijing Cancer Hospital ( Site 1623)
Beijing, Beijing Municipality, 130021
Study Coordinator, +861088196393
- Recruiting
Hunan Cancer Hospital ( Site 1630)
Changsha, Hunan, 410013
Study Coordinator, +86073189762271
- Recruiting
West China Hospital, Sichuan University-Urology Surgery ( Site 1642)
Chengdu, Sichuan, 610041
Study Coordinator, +86028-85422114
- Recruiting
Chongqing University Cancer Hospital ( Site 1603)
Chongqing, Chongqing Municipality, 400030
Study Coordinator, 02365075629
- Recruiting
Southwest Hospital of Third Military Medical University ( Site 1645)
Chongqing, Chongqing Municipality, 400038
Study Coordinator, 023 68765878
- Recruiting
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639)
Fuzhou, Fujian, 350005
Study Coordinator, +86 591-87981262
- Recruiting
The first affiliated hospital of Guangzhou medical university ( Site 1637)
Guangzhou, Guangdong, 510000
Study Coordinator, +86 2083062114
- Recruiting
Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638)
Guangzhou, Guangdong, 510700
Study Coordinator, +86 20-87341851
- Recruiting
Zhejiang Provincial People's Hospital-Urology ( Site 1641)
Hangzhou, Zhejiang, 310014
Study Coordinator, 0571-85893646
- Recruiting
The Second Hospital Of Anhui Medical University ( Site 1633)
Hefei, Anhui, 230000
Study Coordinator, +86 02782201756
- Recruiting
The First Hospital of Jiaxing-urology ( Site 1605)
Jiaxing, Zhejiang, 314001
Study Coordinator, 86-0573-82519999
- Recruiting
Yunnan Province Cancer Hospital ( Site 1643)
Kunming, Yunnan, 650107
Study Coordinator, 0871-68179210
- Recruiting
Nanchong Central Hospital-urology ( Site 1647)
Nanchong, Sichuan, 500643
Study Coordinator, 0817-2606822
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615)
Nanjing, Jiangsu, 210008
Study Coordinator, 86-025-83106666
- Recruiting
Nantong Tumor Hospital-Urology ( Site 1609)
Nantong, Jiangsu, 226361
Study Coordinator, 0513-86729024
- Recruiting
Ningbo First Hospital-Urology ( Site 1608)
Ningbo, Zhejiang, 315010
Study Coordinator, +8616301635665
- Recruiting
Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624)
Shanghai, Shanghai Municipality, 200001
Study Coordinator, (021)58709251
- Recruiting
Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613)
Shanghai, Shanghai Municipality, 200041
Study Coordinator, 021-62483180-571301
- Recruiting
The Second Hospital of Tianjin Medical University ( Site 1616)
Tianjin, Tianjin Municipality, 300211
Study Coordinator, +862288326748
- Recruiting
Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644)
Ürümqi, Xinjiang, 830000
Study Coordinator, 86 09917819156
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University ( Site 1604)
Wenzhou, Zhejiang, 325015
Study Coordinator, +8613601635665
- Recruiting
Tongji Hospital Tongji Medical,Science & Technology ( Site 1632)
Wuhan, Hubei, 430000
Study Coordinator, 027-83665555
- Recruiting
The Central Hospital of Wuhan ( Site 1635)
Wuhan, Hubei, 430014
Study Coordinator, +86 02782211667
- Recruiting
Hubei Cancer Hospital-Urinary surgery ( Site 1631)
Wuhan, Hubei, 430079
Study Coordinator, 8613907110640
- Recruiting
Wuxi People's Hospital ( Site 1612)
Wuxi, Jiangsu, 214023
Study Coordinator, 0510-85350351
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619)
Xi'an, Shaanxi, 710004
Study Coordinator, 029-87679000
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618)
Xi'an, Shaanxi, 710061
Study Coordinator, 029-85323112
- Recruiting
Yantai Yuhuangding Hospital ( Site 1622)
Yantai, Shandong, 264099
Study Coordinator, 86 0535 6691999
Japan30 sites, 26 recruiting
- Recruiting
Akita University Hospital ( Site 0728)
Akita, 010-8543
Study Coordinator, +81188341111
- Recruiting
University of Fukui Hospital ( Site 0735)
Eiheiji-cho,Yoshida-gun, Fukui, 910-1193
Study Coordinator, +81776613111
- Recruiting
Kyushu University Hospital ( Site 0745)
Fukuoka, 812-8582
Study Coordinator, +81926411151
- Recruiting
Fukushima Medical University Hospital ( Site 0758)
Fukushima, 960-1295
Study Coordinator, +81245471111
- Recruiting
Gifu University Hospital ( Site 0736)
Gifu, 501-1112
Study Coordinator, +81-58-230-6000
- Recruiting
Kansai Medical University Hospital ( Site 0739)
Hirakata, Osaka, 573-1191
Study Coordinator, +81-72-804-0101
- Completed
Hiroshima University Hospital ( Site 0743)
Hiroshima, 734-8551
- Completed
Nihon University Itabashi Hospital ( Site 0732)
Itabashiku, Tokyo, 173-8610
- Completed
Kagoshima University Hospital ( Site 0754)
Kagoshima, 890-8520
- Recruiting
Nara Medical University Hospital ( Site 0742)
Kashihara, Nara, 634-8522
Study Coordinator, +81744223051
- Recruiting
Kagawa University Hospital ( Site 0744)
Kita, Kagawa-ken, 761-0701
Study Coordinator, +81878985111
- Recruiting
Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746)
Kitakyushu, Fukuoka, 807-8556
Study Coordinator, +81936031611
- Recruiting
Kobe University Hospital ( Site 0741)
Kobe, Hyōgo, 650-0017
Study Coordinator, +81783825111
- Recruiting
National Hospital Organization Kumamoto Medical Center ( Site 0749)
Kumamoto, 860-0008
Study Coordinator, +81963536501
- Recruiting
The Jikei University Hospital ( Site 0731)
Minato, Tokyo, 105-8471
Study Coordinator, +81339728111
- Recruiting
Miyazaki Prefectural Miyazaki Hospital ( Site 0752)
Miyazaki, 880-8510
Study Coordinator, +81985244181
- Recruiting
University of Miyazaki Hospital ( Site 0751)
Miyazaki, 889-1692
Study Coordinator, +81-98-585-1510
- Recruiting
Kanazawa Medical University Hospital ( Site 0734)
Mukai-awagasaki, Ishikawa-ken, 920-0265
Study Coordinator, +81-76-286-3511
- Recruiting
Nagano Municipal Hospital ( Site 0757)
Nagano, 381-8551
Study Coordinator, +81262951199
- Completed
National Hospital Organization Oita Medical Center ( Site 0750)
Ōita, 870-0263
- Recruiting
National Hospital Organization Nagasaki Medical Center ( Site 0748)
Ōmura, Nagasaki, 856-8562
Study Coordinator, +81-957-52-3121
- Recruiting
Saga-Ken Medical Centre Koseikan ( Site 0747)
Saga, Saga-ken, 840-8571
Study Coordinator, +81952242171
- Recruiting
Bell Land General Hospital ( Site 0740)
Sakai, Osaka, 599-8247
Study Coordinator, +81722342001
- Recruiting
Toho University Sakura Medical Center ( Site 0730)
Sakura, Chiba, 285-8741
Study Coordinator, +81434628811
- Recruiting
Sapporo Medical University Hospital ( Site 0726)
Sapporo, Hokkaido, 060-8543
Study Coordinator, +81-11-611-2111
- Recruiting
Hokkaido University Hospital ( Site 0756)
Sapporo, Hokkaido, 060-8648
Study Coordinator, +81117161161
- Recruiting
Nanbu Tokushukai Hospital ( Site 0755)
Shimajiri, Okinawa, 901-0417
Study Coordinator, +81-98-998-3221
- Recruiting
The University of Osaka Hospital ( Site 0738)
Suita, Osaka, 565-0871
Study Coordinator, +81-6-6879-5111
- Recruiting
Mie University Hospital ( Site 0737)
Tsu, Mie-ken, 514-8507
Study Coordinator, +81-59-232-1111
- Recruiting
Yokohama City University Medical Center ( Site 0733)
Yokohama, Kanagawa, 232-0024
Study Coordinator, +81452615656
Brazil14 sites, 14 recruiting
- Recruiting
Hospital Mario Penna ( Site 0264)
Belo Horizonte, Minas Gerais, 30380-472
Study Coordinator, +551 31 3299-9543
- Recruiting
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251)
Bragança Paulista, São Paulo, 12916-542
Study Coordinator, +551124901366
- Recruiting
ICTRIALS Pesquisa e Desenvolvimento ( Site 0274)
Curitiba, Paraná, 80510-130
Study Coordinator, +5541992620036
- Recruiting
Hospital Universitário Evangélico Mackenzie ( Site 0252)
Curitiba, Paraná, 80730-150
Study Coordinator, +5541988300578
- Recruiting
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256)
Fortaleza, Ceará, 60336-232
Study Coordinator, +558532865934
- Recruiting
Clínica de Neoplasias Litoral ( Site 0269)
Itajaí, Santa Catarina, 88301-220
Study Coordinator, +5549984292436
- Recruiting
Hospital São Lucas da PUCRS ( Site 0270)
Porto Alegre, Rio Grande do Sul, 90610-000
Study Coordinator, +5551999892554
- Recruiting
Obras Sociais Irma Dulce ( Site 0255)
Salvador, Estado de Bahia, 41680-430
Study Coordinator, +55 71 3310-1978
- Recruiting
Hospital de Base de São José do Rio Preto ( Site 0275)
São José do Rio Preto, São Paulo, 15090-000
Study Coordinator, +551732015054
- Recruiting
Hospital São Domingos ( Site 0258)
São Luís, Maranhão, 65060-645
Study Coordinator, +55 98 3216-8100
- Recruiting
Hospital Paulistano ( Site 0259)
São Paulo, 01321-001
Study Coordinator, +55 11 3141-1083
- Recruiting
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263)
Taubaté, São Paulo, 12030-200
Study Coordinator, 11 12 3631 8559
- Recruiting
Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262)
Uberaba, Minas Gerais, 38025-350
Study Coordinator, +55 34 991706916
- Recruiting
Hospital Santa Rita de Cassia ( Site 0271)
Vitória, Espírito Santo, 29043-260
Study Coordinator, +55 27 3334-8183
Germany13 sites, 9 recruiting
- Recruiting
Marien-Krankenhaus ( Site 0515)
Bergisch Gladbach, North Rhine-Westphalia, 51465
Study Coordinator, +4922029384311
- Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)
Berlin, 10117
Study Coordinator, 0049 30 450615285
- Recruiting
Vivantes Klinikum Am Urban ( Site 0512)
Berlin, 10967
Study Coordinator, 004930130226301
- Completed
Universitaetsklinikum Koeln ( Site 0518)
Cologne, North Rhine-Westphalia, 50937
- Completed
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528)
Dresden, Saxony, 01307
- Recruiting
Urologicum Duisburg ( Site 0538)
Duisburg, North Rhine-Westphalia, 47169
Study Coordinator, +4920360012919
- Recruiting
Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506)
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Study Coordinator, +4976127028900
- Recruiting
Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527)
Göttingen, Lower Saxony, 37075
Study Coordinator, +4955139 68145
- Recruiting
Universitaetsklinikum Heidelberg ( Site 0531)
Heidelberg, Baden-Wurttemberg, 69120
Study Coordinator, +496221565982
- Completed
Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510)
Marburg, Hesse, 35043
- Active, not recruiting
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521)
Munich, Bavaria, 81675
- Recruiting
Studienpraxis Urologie ( Site 0529)
Nürtingen, Baden-Wurttemberg, 72622
Study Coordinator, 491703809223
- Recruiting
Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523)
Regensburg, Bavaria, 93053
Study Coordinator, +499417827524
United Kingdom13 sites, 12 recruiting
- Recruiting
Addenbrooke's Hospital ( Site 1426)
Cambridge, Cambridgeshire, CB2 2QQ
Study Coordinator, 01223216083
- Recruiting
Royal Derby Hospital ( Site 1431)
Derby, Derbyshire, DE22 3NE
Study Coordinator, +441332340131
- Recruiting
The Beatson West of Scotland Cancer Centre ( Site 1428)
Glasgow, Glasgow City, G12 0YN
Study Coordinator, +441413017000
- Recruiting
University College London Hospital ( Site 1437)
London, London, City of, NW1 2PG
Study Coordinator, 0203 447 3042
- Recruiting
Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
London, London, City of, SE1 9RT
Study Coordinator, 02071882007
- Completed
St. George's Hospital-Oncology ( Site 1441)
London, London, City of, SW17 0QT
- Recruiting
Charing Cross Hospital ( Site 1434)
London, London, City of, W6 8RF
Study Coordinator, +4402033138335
- Recruiting
The Christie NHS Foundation Trust ( Site 1436)
Manchester, m20 4bx
Study Coordinator, +441614463000
- Recruiting
Mount Vernon Cancer Centre ( Site 1440)
Northwood, England, HA6 2RN
Study Coordinator, 0203 826 2164
- Recruiting
GenesisCare - Oxford ( Site 1442)
Oxford, Oxfordshire, OX4 6LB
Study Coordinator, +447407796352
- Recruiting
Torbay Hospital ( Site 1429)
Torquay, Devon, TQ2 7AA
Study Coordinator, 01803 656627
- Recruiting
The Royal Cornwall Hospital ( Site 1430)
Truro, England, TR1 3LJ
Study Coordinator, 01872258345
- Recruiting
GenesisCare - Windsor ( Site 1443)
Windsor, Windsor And Maidenhead, SL4 3HD
Study Coordinator, +447879262807
France11 sites, 9 recruiting
- Completed
Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458)
Avignon, Vaucluse, 84000
- Recruiting
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461)
Bordeaux, Aquitaine, 33076
Study Coordinator, +33556333333
- Recruiting
CHU-BREST Cavale Blanche ( Site 0456)
Brest, Finistere, 29200
Study Coordinator, +33298223395
- Recruiting
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454)
Clermont-Ferrand, Puy-de-Dome, 63003
Study Coordinator, +33473278005
- Recruiting
Centre Bourgogne ( Site 0464)
Lille, Hauts-de-France, 59000
Study Coordinator, +33 3 20 00 97 57
- Recruiting
CENTRE LEON BERARD ( Site 0459)
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373
Study Coordinator, 33469856243
- Recruiting
Groupe Hospitalier Paris Saint Joseph ( Site 0465)
Paris, 75014
Study Coordinator, +33144128524
- Completed
Ramsay Santé - Clinical La Croix Du Sud ( Site 0460)
Quint-Fonsegrives, Haute-Garonne, 31130
- Recruiting
Hopitaux Universitaires de Strasbourg- Hopital de Hautepierre ( Site 0451)
Strasbourg, Bas-Rhin, 67200
Study Coordinator, +33368767208
- Recruiting
Hôpital Foch ( Site 0455)
Suresnes, Hauts-de-Seine, 92150
Study Coordinator, +33146253581
- Recruiting
Gustave Roussy ( Site 0452)
Villejuif, Val-de-Marne, 94800
Study Coordinator, +33 1 42 11 42 11
Turkey (Türkiye)9 sites, 9 recruiting
- Recruiting
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379)
Adana, 01250
Study Coordinator, 03223272727
- Recruiting
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376)
Ankara, 06230
Study Coordinator, 03123053217
- Recruiting
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377)
Ankara, 06800
Study Coordinator, +903125526000
- Recruiting
Koc Universitesi Hastanesi ( Site 1384)
Istanbul, 34010
Study Coordinator, +908502508250
- Recruiting
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381)
Istanbul, 34147
Study Coordinator, +902124147171
- Recruiting
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383)
Istanbul, 34668
Study Coordinator, +902124143000
- Recruiting
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378)
Istanbul, 34722
Study Coordinator, 02166065200
- Recruiting
Ege Universitesi Hastanesi-Medical Oncology ( Site 1380)
Izmir, 35100
Study Coordinator, +902323903917
- Recruiting
Samsun Medical Park Hastanesi-medical oncology ( Site 1382)
Samsun, 55200
Study Coordinator, +90 (539) 780 90 07
Israel8 sites, 8 recruiting
- Recruiting
Emek Medical Center ( Site 0680)
Afula, 1834111
Study Coordinator, 0546708579
- Recruiting
Rambam Health Care Campus-Oncology Division ( Site 0676)
Haifa, 3109601
Study Coordinator, 04-7776234
- Recruiting
Shaare Zedek Medical Center ( Site 0679)
Jerusalem, 9103102
Study Coordinator, 02-666-6044
- Recruiting
Hadassah Medical Center ( Site 0683)
Jerusalem, 9112001
Study Coordinator, 02-6777111
- Recruiting
Meir Medical Center. ( Site 0682)
Kfar Saba, 4428164
Study Coordinator, 0503745684
- Recruiting
Rabin Medical Center ( Site 0678)
Petah Tikva, 4941492
Study Coordinator, 039378074
- Recruiting
Sheba Medical Center ( Site 0677)
Ramat Gan, 5265601
Study Coordinator, +972-35302191
- Recruiting
Sourasky Medical Center ( Site 0681)
Tel Aviv, 6423906
Study Coordinator, 972-36972951
Mexico8 sites, 8 recruiting
- Recruiting
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928)
Guadalajara, Jalisco, 44630
Study Coordinator, 3331721132
- Recruiting
Health Pharma Professional Research S.A. de C.V: ( Site 0929)
Mexico City, Mexico City, 03100
Study Coordinator, 5591974888
- Recruiting
Higiea Oncologia ( Site 0938)
Mexico City, Mexico City, 11810
Study Coordinator, +525554137773
- Recruiting
Centro de Investigacion Clinica de Oaxaca ( Site 0934)
Mexico City, Mexico City, 68020
Study Coordinator, +529515473137
- Recruiting
Filios Alta Medicina ( Site 0931)
Monterrey, Nuevo León, 64460
Study Coordinator, +528183478742
- Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932)
Monterrey, Nuevo León, 64460
Study Coordinator, +528110665640
- Recruiting
Eukarya Pharmasite S.C. ( Site 0939)
Monterrey, Nuevo León, 64718
Study Coordinator, +5218115009790
- Recruiting
Quemex Medical and Research ( Site 0937)
Tlalpan, Mexico City, 14308
Study Coordinator, +525556783461
Spain8 sites, 8 recruiting
- Recruiting
Complexo Hospitalario Universitario A Coruna ( Site 1288)
A Coruña, La Coruna, 15006
Study Coordinator, 981178000 Ext 291471
- Recruiting
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284)
Barcelona, Catalonia, 08036
Study Coordinator, +34932275402
- Recruiting
Hospital Universitario de Burgos-Oncología ( Site 1281)
Burgos, 09006
Study Coordinator, +34947281800 (35729)
- Recruiting
Institut Català d'Oncologia (ICO) - Girona ( Site 1285)
Girona, Gerona, 17007
Study Coordinator, +34972225834
- Recruiting
Hospital Insular de Gran Canaria-Oncology ( Site 1280)
Las Palmas de Gran Canaria, Las Palmas, 35016
Study Coordinator, +34928441738
- Recruiting
Hospital Quirón Málaga ( Site 1286)
Málaga, 29004
Study Coordinator, +34 95 194 00 00
- Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283)
Pozuelo de Alarcón, Madrid, 28223
Study Coordinator, +34914521987
- Recruiting
Hospital Universitari Parc Tauli-oncologia ( Site 1282)
Sabadell, Barcelona, 08208
Study Coordinator, +34932240084
Canada7 sites, 7 recruiting
- Recruiting
BC Cancer Abbotsford-Clinical Trials Unit ( Site 0287)
Abbotsford British Columbia, British Columbia, V2S 0C2
Study Coordinator, 604-851-4710 x645274
- Recruiting
Cross Cancer Institute ( Site 0281)
Edmonton, Alberta, T6G 1Z2
Study Coordinator, 780-432-8771
- Recruiting
Trillium Health Partners - Credit Valley Hospital ( Site 0289)
Mississauga, Ontario, L5M 2N1
Study Coordinator, 9058134299
- Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0276)
Montreal, Quebec, H2X 3E4
Study Coordinator, 514 890 8000 x 27466
- Recruiting
The Ottawa Hospital - General Campus ( Site 0286)
Ottawa, Ontario, K1H 8L6
Study Coordinator, 613-737-7700
- Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277)
Québec, Quebec, G1J 1Z4
Study Coordinator, 418-525-4444
- Recruiting
Sunnybrook Research Institute ( Site 0285)
Toronto, Ontario, M4N 3M5
Study Coordinator, 416-480-5000
Colombia7 sites, 6 recruiting
- Completed
Los Cobos Medical Center ( Site 0336)
Bogotá, Bogota D.C., 110121
- Recruiting
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326)
Bogotá, Bogota D.C., 111321
Study Coordinator, 6017058333
- Recruiting
Fundación Valle del Lili ( Site 0330)
Cali, Valle del Cauca Department, 760032
Study Coordinator, +573133288646
- Recruiting
Clínica Imbanaco S.A.S ( Site 0334)
Cali, Valle del Cauca Department, 760042
Study Coordinator, +576023851000
- Recruiting
IMAT S.A.S ( Site 0329)
Montería, Departamento de Córdoba, 230002
Study Coordinator, +573135342052
- Recruiting
Fundación Cardiovascular de Colombia ( Site 0328)
Piedecuesta, Santander Department, 681017
Study Coordinator, +573203400438
- Recruiting
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327)
Valledupar, Cesar Department, 200001
Study Coordinator, +57 3158505190
Taiwan7 sites, 7 recruiting
- Recruiting
Kaohsiung Veterans General Hospital ( Site 1337)
Kaohsiung City, 81362
Study Coordinator, +88673422121x73016
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331)
Kaohsiung City, 83301
Study Coordinator, +886-7-7317123 #3267
- Recruiting
China Medical University Hospital-Department of Urology ( Site 1335)
Taichung, 40447
Study Coordinator, +886-4-2205-2121
- Recruiting
Taichung Veterans General Hospital ( Site 1338)
Taichung, 40705
Study Coordinator, +886-4-23592525
- Recruiting
Chi Mei Medical Center ( Site 1336)
Tainan, Tainan, 71004
Study Coordinator, 886 933072414
- Recruiting
Taipei Veterans General Hospital ( Site 1332)
Taipei, 112
Study Coordinator, +886228757519x315
- Recruiting
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334)
Taoyuan, 333
Study Coordinator, +886-4-23592525
Chile6 sites, 6 recruiting
- Recruiting
Fundación Arturo López Pérez ( Site 0303)
Santiago, Region M. de Santiago, 7500921
Study Coordinator, 56224205098
- Recruiting
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304)
Santiago, Region M. de Santiago, 8330024
Study Coordinator, 56934331806
- Recruiting
Bradfordhill-Clinical Area ( Site 0301)
Santiago, Region M. de Santiago, 8420383
Study Coordinator, +56229490970
- Recruiting
Clinica Universidad Catolica del Maule-Oncology ( Site 0306)
Talca, Maule Region, 3465584
Study Coordinator, 56947532700
- Recruiting
CIDO SpA-Oncology ( Site 0302)
Temuco, Araucania, 4810218
Study Coordinator, 56934016366
- Recruiting
ONCOCENTRO APYS-ACEREY ( Site 0305)
Viña del Mar, Valparaiso, 2520598
Study Coordinator, 56323320850
Czechia6 sites, 5 recruiting
- Recruiting
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403)
Brno, Brno-mesto, 656 53
Study Coordinator, +420543136216
- Recruiting
Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404)
Brno, South Moravian, 602 00
Study Coordinator, +420543183087
- Completed
Krajská nemocnice Liberec-Department of Urology ( Site 0407)
Liberec, Liberec Region, 460 01
- Recruiting
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405)
Olomouc, 77900
Study Coordinator, +420588444295
- Recruiting
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401)
Prague, Praha 5, 150 06
Study Coordinator, +420224434700
- Recruiting
Vseobecna fakultni nemocnice v Praze ( Site 0406)
Prague, 12808
Study Coordinator, +420224962219
Italy6 sites, 6 recruiting
- Recruiting
Ospedale Cannizzaro ( Site 1455)
Catania, 95126
Study Coordinator, +393487142015
- Recruiting
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456)
Foggia, 71100
Study Coordinator, +390881736426
- Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454)
Meldola, Emilia-Romagna, 47014
Study Coordinator, +390543739100
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452)
Milan, Lombardy, 20133
Study Coordinator, 00390223903033
- Recruiting
Ospedale San Raffaele-Oncologia Medica ( Site 1451)
Milan, 20132
Study Coordinator, +390226435668
- Recruiting
Azienda Ospedaliera Santa Maria Terni ( Site 1458)
Terni, 05100
Study Coordinator, +390744205410
Portugal6 sites, 6 recruiting
- Recruiting
Hospital de Cascais Doutor José de Almeida ( Site 1158)
Alcabideche, Lisbon District, 2755-009
Study Coordinator, (351) 214653000
- Recruiting
Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151)
Braga, 4710-243
Study Coordinator, 351253027249
- Recruiting
Hospital CUF - Tejo ( Site 1157)
Lisbon, 1350-352
Study Coordinator, +35121 392 6100
- Recruiting
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153)
Lisbon, 1649-035
Study Coordinator, 00351217805000
- Recruiting
Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152)
Porto, 4099-001
Study Coordinator, 351222077500
- Recruiting
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156)
Vila Nova de Gaia, Porto District, 4434-502
Study Coordinator, 351227865100
Romania6 sites, 4 recruiting
- Recruiting
Delta Health Care SRL ( Site 1507)
Bucharest, 014142
Study Coordinator, +40 21 9977
- Recruiting
Spitalul Clinic ''Prof Dr. Theodor Burghele'' ( Site 1505)
Bucharest, 050659
Study Coordinator, +40214106910
- Recruiting
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu ( Site 1504)
Bucharest, 11461
Study Coordinator, +40213161600
- Completed
Cardiomed SRL Cluj-Napoca ( Site 1503)
Cluj-Napoca, Cluj, 400015
- Recruiting
Centrul de Oncologie "Sfântul Nectarie" ( Site 1501)
Craiova, Dolj, 200746
Study Coordinator, +40731604432
- Completed
SC Radiotherapy Center Cluj SRL ( Site 1502)
Florești, Cluj, 407280
South Africa6 sites, 5 recruiting
- Completed
Cape Town Oncology Trials ( Site 1233)
Cape Town, Western Cape, 7570
- Recruiting
Wits Clinical Research ( Site 1234)
Johannesburg, Gauteng, 2193
Study Coordinator, +113390600
- Recruiting
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230)
Port Elizabeth, Eastern Cape, 6055
Study Coordinator, 27413630581
- Recruiting
Wilgers Oncology Centre ( Site 1232)
Pretoria, Gauteng, 0040
Study Coordinator, +27128072744
- Recruiting
Curo Oncology. ( Site 1237)
Pretoria, Gauteng, 0084
Study Coordinator, +27 12 335 6771
- Recruiting
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236)
Pretoria, Gauteng, 0181
Study Coordinator, +27123466701
South Korea6 sites, 6 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital-Urology ( Site 1252)
Buk-gu, Kyongsangbuk-do, 41404
Study Coordinator, +82532002400
- Recruiting
National Cancer Center-Center for Urologic Cancer ( Site 1254)
Goyang-si, Kyonggi-do, 10408
Study Coordinator, 82-31-920-1740
- Recruiting
Pusan National University Yangsan Hospital ( Site 1256)
Pusan, Kyongsangnam-do, 50612
Study Coordinator, +82553602672
- Recruiting
Seoul National University Bundang Hospital-Urology ( Site 1253)
Seongnam, Kyonggi-do, 13620
Study Coordinator, 82-31-787-7342
- Recruiting
Seoul National University Hospital-Urology ( Site 1251)
Seoul, 03080
Study Coordinator, +82-053-3027
- Recruiting
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255)
Seoul, 06591
Study Coordinator, +82222581401
Australia5 sites, 5 recruiting
- Recruiting
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211)
Brisbane, Queensland, 4029
Study Coordinator, +61736467712
- Recruiting
Monash Health ( Site 0219)
Clayton, Victoria, 3168
Study Coordinator, 0385722415
- Recruiting
Macquarie University-MQ Health Clinical Trials Unit ( Site 0214)
Macquarie University, New South Wales, 2109
Study Coordinator, +61298122956
- Recruiting
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210)
Melbourne, Victoria, 3000
Study Coordinator, 0385595000
- Recruiting
Westmead Hospital ( Site 0212)
Westmead, New South Wales, 2145
Study Coordinator, +61288905200
Guatemala5 sites, 5 recruiting
- Recruiting
MEDI-K ( Site 0576)
Guatemala City, 01009
Study Coordinator, 50249340261
- Recruiting
CELAN,S.A ( Site 0579)
Guatemala City, 01010
Study Coordinator, 50242142081
- Recruiting
INTEGRA Cancer Institute-Oncology ( Site 0578)
Guatemala City, 01010
Study Coordinator, 50254530410
- Recruiting
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577)
Guatemala City, 01010
Study Coordinator, 50230635474
- Recruiting
Sanatorio Nuestra Senora del Pilar ( Site 0580)
Guatemala City, 01015
Study Coordinator, 50258190718
Malaysia5 sites, 4 recruiting
- Recruiting
Hospital Sultan Ismail ( Site 0905)
Johor Bahru, Johor, 81100
Study Coordinator, +6073565155
- Recruiting
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903)
Kuala Lumpur, 50586
Study Coordinator, +60326155810
- Recruiting
Sarawak General Hospital-Radiotherapy Unit ( Site 0901)
Kuching, Sarawak, 93586
Study Coordinator, +6082276820
- Recruiting
University Malaya Medical Centre ( Site 0902)
Lembah Pantai, Kuala Lumpur, 59100
Study Coordinator, +60479492351
- Completed
National Cancer Institute ( Site 0904)
Putrajaya, Putrajaya, 62250
Thailand5 sites, 5 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital ( Site 1356)
Bangkoknoi, Bangkok, 10700
Study Coordinator, +6686-089-9245
- Recruiting
Songklanagarind hospital ( Site 1352)
Hat Yai, Changwat Songkhla, 90110
Study Coordinator, .+6674451250
- Recruiting
Faculty of Medicine - Khon Kaen University ( Site 1351)
Muang, Changwat Khon Kaen, 40002
Study Coordinator, +669-7141913
- Recruiting
Maharaj Nakorn Chiang Mai Hospital ( Site 1353)
Muang, Chiang Mai, 50200
Study Coordinator, +6653936046
- Recruiting
Chulalongkorn University ( Site 1355)
Pathumwan, Bangkok, 10330
Study Coordinator, +6622564533
Estonia4 sites, 4 recruiting
- Recruiting
Pärnu Haigla ( Site 1550)
Pärnu, Pärnumaa, 80010
Study Coordinator, +3724473301
- Recruiting
East-Tallinn Central Hospital ( Site 1528)
Tallinn, Harju, 11314
Study Coordinator, +3726067771
- Recruiting
North Estonia Medical Centre Foundation ( Site 1526)
Tallinn, Harju, 13419
Study Coordinator, +3726172304
- Recruiting
Tartu University Hospital-Radiotherapy and oncology ( Site 1527)
Tartu, Tartu, 50406
Study Coordinator, +3727319813
Hungary4 sites, 3 recruiting
- Recruiting
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631)
Budapest, Pest County, 1122
Study Coordinator, +36122486001171
- Active, not recruiting
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632)
Debrecen, 4032
- Recruiting
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630)
Miskolc, Borsod-Abauj Zemplen county, 3526
Study Coordinator, +36204108060
- Recruiting
Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636)
Salgótarján, Nógrád megye, 3100
Study Coordinator, +3632522000
Peru4 sites, 3 recruiting
- Recruiting
Aliada-Oncologìa ( Site 1055)
Lima, 15036
Study Coordinator, 5116505000
- Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052)
Lima, 15036
Study Coordinator, +51941042554
- Recruiting
Oncosalud-Clinical Research ( Site 1057)
Lima, 15036
Study Coordinator, 01 2053500
- Active, not recruiting
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054)
Lima, 15038
Singapore4 sites, 4 recruiting
- Recruiting
National University Hospital ( Site 1201)
Singapore, Central Singapore, 119074
Study Coordinator, 6569082222
- Recruiting
National Cancer Centre Singapore ( Site 1202)
Singapore, Central Singapore, 168583
Study Coordinator, +6564368000
- Recruiting
Singapore General Hospital ( Site 1204)
Singapore, Central Singapore, 169608
Study Coordinator, +6590059585
- Recruiting
Tan Tock Seng Hospital-Medical Oncology ( Site 1203)
Singapore, Central Singapore, 308433
Study Coordinator, +65-62566011
Costa Rica3 sites, 3 recruiting
- Recruiting
CIMCA-Hemato-Oncology ( Site 0380)
San José, Provincia de San José, 10103
Study Coordinator, 50683893636
- Recruiting
Onco Tech, S.A. ( Site 0376)
San José, 10103
Study Coordinator, 50688448187
- Recruiting
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379)
Santa Ana, Provincia de San José, 10903
Study Coordinator, 50688308999
Greece3 sites, 2 recruiting
- Recruiting
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551)
Athens, Attica, 115 28
Study Coordinator, +302132162513
- Recruiting
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552)
Chaïdári, Attica, 124 62
Study Coordinator, +302105832547
- Completed
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553)
Pátrai, Achaia, 26504
Puerto Rico3 sites, 2 recruiting
- Completed
Advance Urology and Laparoscopic Center ( Site 1178)
Ponce, 00716
- Recruiting
Ad-Vance Medical Research-Research ( Site 1177)
Ponce, 00717
Study Coordinator, +1787-651-6697
- Recruiting
Pan American Center for Oncology Trials - Ciudadela ( Site 1176)
San Juan, 00909
Study Coordinator, +1 787-407-3333
Hong Kong2 sites, 2 recruiting
- Recruiting
Hong Kong Integrated Oncology Centre ( Site 0603)
Central, 999077
Study Coordinator, +85237006888
- Recruiting
Queen Mary Hospital ( Site 0602)
Hong Kong
Study Coordinator, +85222553838
Ireland2 sites, 2 recruiting
- Recruiting
St. Vincent's University Hospital ( Site 0652)
Dublin, Dublin, D04 T6F4
Study Coordinator, +35312214000
- Recruiting
Tallaght University Hospital ( Site 0651)
Dublin, D24 NR0A
Study Coordinator, +35314144299
Latvia2 sites, 1 recruiting
- Active, not recruiting
Liepaja Regional Hospital ( Site 1553)
Liepāja, LV3414
- Recruiting
Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551)
Riga, 1002
Study Coordinator, +371 29262596
Lithuania2 sites, 2 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576)
Kaunas, Kaunas County, 50161
Study Coordinator, +37037326090
- Recruiting
Vilnius University Hospital Santaros Clinics Affiliate - National Cancer Center ( Site 1577)
Vilnius, LT-08406
Study Coordinator, +37052786815
New Zealand2 sites, 1 recruiting
- Recruiting
Auckland City Hospital ( Site 1033)
Auckland, 1023
Study Coordinator, +6493074949 x 21468
- Completed
Dunedin Hospital ( Site 1032)
Dunedin, Otago, 9016
Slovakia2 sites, 2 recruiting
- Recruiting
UROEXAM ( Site 1479)
Nitra, Nitra Region, 949 01
Study Coordinator, +421377729428
- Recruiting
Privatna Urologicka Ambulancia ( Site 1478)
Trenčín, Trenčín Region, 911 01
Study Coordinator, +421905343753
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska Universitetssjukhuset Solna ( Site 1302)
Stockholm, Stockholm County, 171 64
Study Coordinator, +46812370000
- Recruiting
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301)
Uppsala, Uppsala County, 751 85
Study Coordinator, 0046186110000
About this study
Official title: 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)
The purpose of this study is to assess the efficacy and safety of opevesostat plus daily corticosteroids 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 overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
Read the detailed description
Per Protocol Amendment 08, OS was moved to be a secondary outcome measure. Per Protocol Amendment 11, OS was returned to a primary outcome measure.
- Being tested
- Opevesostat, Dexamethasone, Fludrocortisone acetate, Hydrocortisone, Abiraterone acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpevesostatDrug
Also called MK-5684
Administered orally
DexamethasoneDrug
Administered orally
Fludrocortisone acetateDrug
Administered orally
HydrocortisoneDrug
Administered orally or IM as a rescue drug
Abiraterone acetateDrug
Also called Zytiga, Yonsa
Administered orally
Prednisone acetateDrug
Administered orally
EnzalutamideDrug
Also called Xtandi
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Daily Corticosteroids + Opevesostat | Experimental | 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. Receives: Drug: Opevesostat; Drug: Dexamethasone; Drug: Fludrocortisone acetate; Drug: Hydrocortisone |
| Alternative Next-Generation Hormonal Agent (NHA) | Active comparator | 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. Receives: Drug: Abiraterone acetate; Drug: Prednisone acetate; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 82 months
Secondary outcomes (13)
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from randomization to the first documented disease progression per PCWG-modified RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Measured: Up to approximately 52 months
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
TFST is defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurred first.
Measured: Up to approximately 82 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per PCWG-modified RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Measured: Up to approximately 82 months
Duration of Response (DOR)
For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death from any cause, whichever occurs first.
Measured: Up to approximately 82 months
Time to Pain Progression (TTPP)
TTPP is defined as the time from randomization to pain progression. TTTP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm [AQA] Score).
Measured: Up to approximately 82 months
Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The change from baseline in FACT-G total score will be reported.
Measured: Baseline and up to approximately 82 months
Time to Deterioration (TTD) in FACT-G Total Score
The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. TTD in FACT-G total score will be reported.
Measured: Up to approximately 82 months
Overall Improvement in FACT-G Total Score
The FACT-G is a HRQoL 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The overall improvement in FACT-G total score will be reported.
Measured: Up to approximately 82 months
Time to Prostate-specific Antigen (PSA) Progression
The time to PSA progression is the time from randomization to PSA progression. The PSA progression date is defined as the date of: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there was PSA decline from baseline; OR 2) ≥25% increase and ≥2 ng/mL increase from baseline.
Measured: Up to approximately 82 months
PSA Response Rate
The PSA response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed ≥3 weeks from the original response.
Measured: Up to approximately 82 months
Time to First Symptomatic Skeletal-Related Event (TSSRE)
TSSRE is the time from randomization to the first symptomatic skeletal-related event defined as: 1. use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. occurrence of spinal cord compression 4. tumor-related orthopedic surgical intervention, whichever occurs first.
Measured: Up to approximately 82 months
Number of Participants Who Experience an AE
An AE is defined as any unfavorable and unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.
Measured: Up to approximately 82 months
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 82 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Dec 2023
- Primary completion10 May 2028 (estimated)
- Study completion2 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136650
- Sponsor's protocol ID
- 5684-004
- Other IDs
- MK-5684-004, jRCT2031240030, 2023-504957-11-00, U1111-1288-5002, 2023
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Yu EY, Gratzke C, Burotto M, Zhang AY, Levesque E, Ortega F, Peer A, Vile D, Chen ZH, Song Y, Schloss C, Todoric J, Garratt C, Poehlein C, Antonarakis ES, Fizazi K. Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs. Future Oncol. 2026 Mar;22(7):765-772. doi: 10.1080/14796694.2025.2595914. Epub 2026 Feb 23.
PubMed 41732008