AzTrials
AzTrials

Prostate Cancer MetastaticPhase 3OMAHA-003NCT06136624

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

A Phase 3 study testing Opevesostat, Abiraterone acetate and Enzalutamide in people with Prostate Cancer Metastatic, run by Merck Sharp & Dohme LLC at 288 sites in 36 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Opevesostat, Abiraterone acetate and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,310 participants
Where
288 sitesin 36 countries
Study dates
31 Dec 2023to 29 Mar 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
  • Has prostate cancer progression while on androgen deprivation therapy (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 by computed tomography/magnetic resonance imaging (CT/MRI).
  • Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
  • Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
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  • Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
  • Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
  • Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
  • Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
  • If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment
  • Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
  • Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
  • 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 can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom

Who cannot join

  • Has a gastrointestinal disorder that might affect absorption
  • Has a history of pituitary dysfunction
  • Has poorly controlled diabetes mellitus
  • Has clinically significant abnormal serum potassium or sodium level
  • Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
  • Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
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  • Has a history of clinically significant ventricular arrhythmias
  • Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
  • Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications
  • Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
  • Has received radium-223 or Lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or Lutetium-177 administered more than 4 weeks before the date of randomization
  • Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
  • Has received colony-stimulating factors within 28 days before the date of randomization
  • Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
  • Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
  • Has a "superscan" bone scan
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has an active infection requiring systemic therapy
  • Has concurrent active HBV or known active HCV infection
  • Has a history of long QTc syndrome
  • Has any of the following at Screening Visit: hypotension (systolic BP <110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
  • Is unable to swallow capsules/tablets
  • Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
  • Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle [Silybum marianum])
  • Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention

Trial locations and contacts

288 sites in 36 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

288 sites in 36 countries

United States48 sites, 33 recruiting

  • Avera Cancer Institute - Aberdeen ( Site 0123)

    Aberdeen, South Dakota, 57401

    Study Coordinator, 605-601-1830

    Recruiting

  • Anschutz Cancer Pavilion ( 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

  • Baltimore Veterans Affairs Medical Center ( Site 0069)

    Baltimore, Maryland, 21201

    Study Coordinator, 410-707-4011

    Recruiting

  • Greenebaum Comprehensive Cancer Center ( Site 0049)

    Baltimore, Maryland, 21201

    Study Coordinator, 410-707-4011

    Recruiting

  • Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083)

    Charleston, South Carolina, 29401

    Completed

  • University of Virginia Health System ( Site 0054)

    Charlottesville, Virginia, 22908

    Study Coordinator, 434-327-3029

    Recruiting

  • University of Illinois at Chicago ( Site 0105)

    Chicago, Illinois, 60612

    Study Coordinator, 973-330-2391

    Recruiting

  • University of Chicago Medical Center ( Site 0045)

    Chicago, Illinois, 60637

    Study Coordinator, 773-702-7609

    Recruiting

  • University Hospitals Cleveland Medical Center ( Site 0043)

    Cleveland, Ohio, 44106

    Study Coordinator, 216-844-3951

    Recruiting

  • Texas Oncology - DFW ( Site 8001)

    Dallas, Texas, 75246

    Completed

  • Henry Ford Hospital ( Site 0015)

    Detroit, Michigan, 48202

    Completed

  • Florida Cancer Specialists - South ( Site 7003)

    Fort Myers, Florida, 33901

    Completed

  • Hattiesburg Clinic Hematology/Oncology ( Site 0120)

    Hattiesburg, Mississippi, 39401

    Study Coordinator, 601-261-1700

    Recruiting

  • University of Colorado Health - Highlands Ranch Hospital ( Site 0111)

    Highlands Ranch, Colorado, 80129

    Study Coordinator, 302-290-3598

    Recruiting

  • Texas Oncology - Gulf Coast ( Site 8002)

    Houston, Texas, 77024

    Study Coordinator, 713-467-1722

    Recruiting

  • University of Iowa ( Site 0047)

    Iowa City, Iowa, 52242

    Completed

  • Colorado Clinical Research ( Site 0067)

    Lakewood, Colorado, 80228

    Completed

  • Comprehensive Cancer Centers of Nevada ( Site 0010)

    Las Vegas, Nevada, 89148

    Study Coordinator, 702-952-1251

    Recruiting

  • University of Kentucky Chandler Medical Center ( Site 0048)

    Lexington, Kentucky, 40536

    Completed

  • University of Colorado Health - Lone Tree Medical Center ( Site 0112)

    Lone Tree, Colorado, 80124

    Study Coordinator, 720-848-5146

    Recruiting

  • Avera Cancer Institute - Marshall ( Site 0122)

    Marshall, Minnesota, 56258

    Study Coordinator, 605-601-1830

    Recruiting

  • Bruce W. Carter Veterans Affairs Medical Center ( Site 0082)

    Miami, Florida, 33125

    Completed

  • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051)

    Miami, Florida, 33136

    Study Coordinator, 305-243-1543

    Recruiting

  • Medical College of Wisconsin ( Site 0020)

    Milwaukee, Wisconsin, 53226

    Study Coordinator, 414-805-4600

    Recruiting

  • M Health Fairview Clinics and Surgery Center ( Site 0019)

    Minneapolis, Minnesota, 55455

    Study Coordinator, 612-626-1422

    Recruiting

  • Avera Cancer Institute - Mitchell ( Site 0121)

    Mitchell, South Dakota, 57301

    Study Coordinator, 605-601-1830

    Recruiting

  • Atlantic Health System Morristown Medical Center ( Site 0115)

    Morristown, New Jersey, 07960

    Study Coordinator, 973-971-7960

    Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-218-4647

    Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 0033)

    New Brunswick, New Jersey, 08903

    Completed

  • Yale-New Haven Hospital-Yale Cancer Center ( Site 0064)

    New Haven, Connecticut, 06510

    Study Coordinator, 203-737-8076

    Recruiting

  • Ochsner Clinic Foundation ( Site 0108)

    New Orleans, Louisiana, 70121

    Completed

  • University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095)

    Omaha, Nebraska, 68105

    Study Coordinator, 402-559-8500

    Recruiting

  • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040)

    Orange, California, 92868

    Completed

  • Stanford Cancer Center ( Site 0036)

    Palo Alto, California, 94304

    Study Coordinator, 650-725-2078

    Recruiting

  • Avera Cancer Institute - Pierre ( Site 0118)

    Pierre, South Dakota, 57501

    Study Coordinator, 605-224-3370

    Recruiting

  • AHN Allegheny General Hospital ( Site 0001)

    Pittsburgh, Pennsylvania, 15212

    Completed

  • Oregon Health and Science University ( Site 0028)

    Portland, Oregon, 97239

    Completed

  • VA Portland Health Care System ( Site 0058)

    Portland, Oregon, 97239

    Study Coordinator, 503-220-8262

    Recruiting

  • VCU Health Adult Outpatient Pavillion ( Site 0061)

    Richmond, Virginia, 23219

    Completed

  • Kaiser Permanente Riverside Medical Center ( Site 0099)

    Riverside, California, 92505

    Study Coordinator, 951-809-8361

    Recruiting

  • Blue Ridge Cancer Care ( Site 0004)

    Roanoke, Virginia, 24014

    Study Coordinator, 540-982-0237

    Recruiting

  • Metro-Minnesota Community Clinical Oncology ( Site 0014)

    Saint Louis Park, Minnesota, 55416

    Active, not recruiting

  • Fred Hutchinson Cancer Center ( Site 0013)

    Seattle, Washington, 98109

    Study Coordinator, 617-413-9079

    Recruiting

  • Avera Cancer Institute- Research ( Site 0094)

    Sioux Falls, South Dakota, 57105

    Study Coordinator, 605-322-6900

    Recruiting

  • Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062)

    St Louis, Missouri, 63110

    Study Coordinator, 314-286-2341

    Recruiting

  • James J. Peters VA Medical Center ( Site 0088)

    The Bronx, New York, 10468

    Study Coordinator, 718-584-9000

    Recruiting

  • Avera Cancer Institute - Yankton ( Site 0117)

    Yankton, South Dakota, 57078

    Study Coordinator, 605-655-1800

    Recruiting

Other trials in United States

China39 sites, 39 recruiting

  • Peking University First Hospital-Urology ( Site 0390)

    Beijing, Beijing Municipality, 100034

    Study Coordinator, +86 (010) 64008229

    Recruiting

  • Beijing Friendship Hospital Affiliate of Capital University ( Site 0396)

    Beijing, Beijing Municipality, 100050

    Study Coordinator, +86(010)63138375

    Recruiting

  • Beijing Cancer hospital-Urinary Surgery ( Site 0395)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, 86 010 8812 1122

    Recruiting

  • Hunan Cancer Hospital ( Site 0405)

    Changsha, Hunan, 410013

    Study Coordinator, 073189762270

    Recruiting

  • The Third People's Hospital of Chengdu (CDTPH) ( Site 0428)

    Chengdu, Sichuan, 500643

    Study Coordinator, 67566947

    Recruiting

  • West China Hospital, Sichuan University-Urology Surgery ( Site 0417)

    Chengdu, Sichuan, 610041

    Study Coordinator, +86028-85422114

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University ( Site 0427)

    Chongqing, Chongqing Municipality, 400010

    Study Coordinator, 023 89012012

    Recruiting

  • Chongqing University Cancer Hospital ( Site 0416)

    Chongqing, Chongqing Municipality, 400030

    Study Coordinator, 02365075629

    Recruiting

  • Southwest Hospital of Third Military Medical University ( Site 0420)

    Chongqing, Chongqing Municipality, 400038

    Study Coordinator, 023 68765878

    Recruiting

  • Chongqing Three Gorges Central Hospital's ( Site 0426)

    Chongqing, Chongqing Municipality, 404100

    Study Coordinator, 023 58103150

    Recruiting

  • The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414)

    Fuzhou, Fujian, 350005

    Study Coordinator, +86059187983333

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University ( Site 0412)

    Guangzhou, Guangdong, 510230

    Study Coordinator, +8602034294311

    Recruiting

  • Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413)

    Guangzhou, Guangdong, 511400

    Study Coordinator, +8602087343533

    Recruiting

  • Zhejiang Provincial People's Hospital-Urology ( Site 0378)

    Hangzhou, Zhejiang, 310014

    Study Coordinator, +86 13858019285

    Recruiting

  • Zhejiang Cancer Hospital ( Site 0435)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 0571-88122261

    Recruiting

  • Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408)

    Hefei, Anhui, 230000

    Study Coordinator, +86 02782201756

    Recruiting

  • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436)

    Huaian, Jiangsu, 223300

    Study Coordinator, 0517-80872519

    Recruiting

  • The First Hospital of Jiaxing-urology ( Site 0380)

    Jiaxing, Zhejiang, 314001

    Study Coordinator, +86 13957391616

    Recruiting

  • The Second Affiliated Hospital Of Kunming Medical University ( Site 0429)

    Kunming, Yunnan, 650033

    Study Coordinator, 087165351281

    Recruiting

  • Yunnan Province Cancer Hospital ( Site 0418)

    Kunming, Yunnan, 650107

    Study Coordinator, 0871-68179210

    Recruiting

  • Jiangxi Cancer Hospital ( Site 0386)

    Nanchang, Jiangxi, 330029

    Study Coordinator, 86079188317256

    Recruiting

  • Nanchong Central Hospital-urology ( Site 0422)

    Nanchong, Sichuan, 500643

    Study Coordinator, 08172606822

    Recruiting

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377)

    Nanjing, Jiangsu, 210008

    Study Coordinator, 025-83105910

    Recruiting

  • The First Affiliated Hospital of Ningbo University ( Site 0383)

    Ningbo, Zhejiang, 315010

    Study Coordinator, 86057487085588

    Recruiting

  • Fudan University Shanghai Cancer Center-Urology department ( Site 0376)

    Shanghai, Shanghai Municipality, 200000

    Study Coordinator, 021-38196379

    Recruiting

  • Zhongshan Hospital Fudan University ( Site 0430)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021-31587858

    Recruiting

  • Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388)

    Shanghai, Shanghai Municipality, 200041

    Study Coordinator, 021-62483180

    Recruiting

  • Suining Central Hospital ( Site 0437)

    Suining, Sichuan, 629000

    Study Coordinator, 08252292093

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital ( Site 0392)

    Tianjin, Tianjin Municipality, 300060

    Study Coordinator, +862223340123

    Recruiting

  • The Second Hospital of Tianjin Medical University ( Site 0391)

    Tianjin, Tianjin Municipality, 300211

    Study Coordinator, +8602288326748

    Recruiting

  • Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419)

    Ürümqi, Xinjiang, 830000

    Study Coordinator, 86 09917819156

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379)

    Wenzhou, Zhejiang, 325000

    Study Coordinator, +8618267857001

    Recruiting

  • Tongji Hospital Tongji Medical,Science & Technology ( Site 0407)

    Wuhan, Hubei, 430000

    Study Coordinator, 027-83665555

    Recruiting

  • Hubei Cancer Hospital-Urinary surgery ( Site 0406)

    Wuhan, Hubei, 430079

    Study Coordinator, 8613907110640

    Recruiting

  • Affiliated hospital of Jiangnan university ( Site 0434)

    Wuxi, Jiangsu, 214122

    Study Coordinator, 0510-88682957

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394)

    Xi'an, Shaanxi, 710004

    Study Coordinator, 029-87679000

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393)

    Xi'an, Shaanxi, 710061

    Study Coordinator, 029-85323112

    Recruiting

  • The First Affiliated hospital of Xiamen University-Urology ( Site 0415)

    Xiamen, Fujian, 361003

    Study Coordinator, 0592-2132222

    Recruiting

  • Yantai Yuhuangding Hospital ( Site 0397)

    Yantai, Shandong, 264099

    Study Coordinator, 86 0535 6691999

    Recruiting

Other trials in China

Japan30 sites, 27 recruiting

  • Akita University Hospital ( Site 0904)

    Akita, 010-8543

    Study Coordinator, +81188341111

    Recruiting

  • Asahikawa Medical University Hospital ( Site 0901)

    Asahikawa, Hokkaido, 078-8510

    Study Coordinator, +81-166-65-2111

    Recruiting

  • Kyushu University Hospital ( Site 0919)

    Fukuoka, 812-8582

    Study Coordinator, +81926411151

    Recruiting

  • Fukushima Medical University Hospital ( Site 0933)

    Fukushima, 960-1295

    Study Coordinator, +81245471111

    Recruiting

  • Gifu University Hospital ( Site 0910)

    Gifu, 501-1112

    Study Coordinator, +81-58-230-6000

    Recruiting

  • Kansai Medical University Hospital ( Site 0912)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81-72-804-0101

    Recruiting

  • Hiroshima University Hospital ( Site 0916)

    Hiroshima, 734-8551

    Study Coordinator, +81-82-257-5555

    Recruiting

  • Kagoshima University Hospital ( Site 0929)

    Kagoshima, 890-8520

    Study Coordinator, +81-99-275-5111

    Recruiting

  • Nara Medical University Hospital ( Site 0915)

    Kashihara, Nara, 634-8522

    Completed

  • Kagawa University Hospital ( Site 0917)

    Kita, Kagawa-ken, 761-0701

    Study Coordinator, +81878985111

    Recruiting

  • Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921)

    Kitakyushu, Fukuoka, 807-8556

    Completed

  • Kobe University Hospital ( Site 0914)

    Kobe, Hyōgo, 650-0017

    Study Coordinator, +81783825111

    Recruiting

  • National Hospital Organization Kumamoto Medical Center ( Site 0924)

    Kumamoto, 860-0008

    Study Coordinator, +81963536501

    Recruiting

  • Kurume University Hospital ( Site 0920)

    Kurume, Fukuoka, 830-0011

    Study Coordinator, +81-942-35-3311

    Recruiting

  • The Jikei University Hospital ( Site 0907)

    Minato, Tokyo, 105-8471

    Completed

  • Miyazaki Prefectural Miyazaki Hospital ( Site 0927)

    Miyazaki, 880-8510

    Study Coordinator, +81985244181

    Recruiting

  • University of Miyazaki Hospital ( Site 0926)

    Miyazaki, 889-1692

    Study Coordinator, +81-98-585-1510

    Recruiting

  • Kanazawa Medical University Hospital ( Site 0909)

    Mukai-awagasaki, Ishikawa-ken, 920-0265

    Study Coordinator, +81-76-286-3511

    Recruiting

  • Nagano Municipal Hospital ( Site 0932)

    Nagano, 381-8551

    Study Coordinator, +81-26-295-1199

    Recruiting

  • National Hospital Organization Oita Medical Center ( Site 0925)

    Ōita, 870-0263

    Study Coordinator, +81-97-593-1111

    Recruiting

  • National Hospital Organization Nagasaki Medical Center ( Site 0923)

    Ōmura, Nagasaki, 856-8562

    Study Coordinator, +81-957-52-3121

    Recruiting

  • Saga-Ken Medical Centre Koseikan ( Site 0922)

    Saga, Saga-ken, 840-8571

    Study Coordinator, +81952242171

    Recruiting

  • Bell Land General Hospital ( Site 0913)

    Sakai, Osaka, 599-8247

    Study Coordinator, +81722342001

    Recruiting

  • Toho University Sakura Medical Center ( Site 0906)

    Sakura, Chiba, 285-8741

    Study Coordinator, +81434628811

    Recruiting

  • Sapporo Medical University Hospital ( Site 0902)

    Sapporo, Hokkaido, 060-8543

    Study Coordinator, +81-11-611-2111

    Recruiting

  • Hokkaido University Hospital ( Site 0931)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81117161161

    Recruiting

  • Nanbu Tokushukai Hospital ( Site 0930)

    Shimajiri, Okinawa, 901-0417

    Study Coordinator, +81-98-998-3221

    Recruiting

  • The University of Osaka Hospital ( Site 0911)

    Suita, Osaka, 565-0871

    Study Coordinator, +81668795111

    Recruiting

  • Ehime University Hospital ( Site 0918)

    Tōon, Ehime, 791-0295

    Study Coordinator, +81-89-964-5111

    Recruiting

  • Yokohama City University Medical Center ( Site 0908)

    Yokohama, Kanagawa, 232-0024

    Study Coordinator, +81452615656

    Recruiting

Other trials in Japan

Netherlands11 sites, 7 recruiting

  • Meander Medisch Centrum ( Site 1157)

    Amersfoort, Utrecht, 3813 TZ

    Study Coordinator, +003133 - 850 1189

    Recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153)

    Amsterdam, North Holland, 1066 CX

    Study Coordinator, +31205122569

    Recruiting

  • Amsterdam UMC, locatie VUmc ( Site 1156)

    Amsterdam, North Holland, 1081 HV

    Completed

  • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170)

    Hoofddorp, North Holland, 2134 TM

    Active, not recruiting

  • Medische Centrum Leeuwarden ( Site 1172)

    Leeuwarden, Provincie Friesland, 8934 AD

    Active, not recruiting

  • Radboudumc-Medical Oncology ( Site 1152)

    Nijmegen, Gelderland, 6525 GA

    Study Coordinator, +31 (0)24 361 0353

    Recruiting

  • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151)

    Schiedam, South Holland, 3118 JH

    Study Coordinator, 003110- 4617590

    Recruiting

  • Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163)

    Sittard-Geleen, Limburg, 6162 BG

    Study Coordinator, +31884599740

    Recruiting

  • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164)

    The Hague, South Holland, 2545 AA

    Study Coordinator, +31702102143

    Recruiting

  • ETZ Elisabeth-Internal Medicine ( Site 1160)

    Tilburg, North Brabant, 5022 GC

    Study Coordinator, +3113221 0210

    Recruiting

  • VieCuri Medisch Centrum ( Site 1173)

    Venlo, Limburg, 5912 BL

    Completed

Other trials in Netherlands

Turkey (Türkiye)9 sites, 9 recruiting

  • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554)

    Adana, 01250

    Study Coordinator, +903223444444

    Recruiting

  • Gulhane Egitim Arastirma Hastanesi ( Site 1558)

    Ankara, 06010

    Study Coordinator, 00903123042020

    Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551)

    Ankara, 06230

    Study Coordinator, +90 (312) 305 29 41

    Recruiting

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 1557)

    Ankara, 06520

    Study Coordinator, 903122536666

    Recruiting

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552)

    Ankara, 06800

    Study Coordinator, 00903125526060

    Recruiting

  • Koc Universitesi Hastanesi ( Site 1561)

    Istanbul, 34010

    Study Coordinator, +908502508250

    Recruiting

  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555)

    Istanbul, 34668

    Study Coordinator, 0090212 414 30 00

    Recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553)

    Istanbul, 34722

    Study Coordinator, +902166065200

    Recruiting

  • Samsun Medical Park Hastanesi-medical oncology ( Site 1560)

    Samsun, 55200

    Study Coordinator, +90 (539) 780 90 07

    Recruiting

Other trials in Turkey (Türkiye)

Brazil8 sites, 7 recruiting

  • Hospital Felicio Rocho ( Site 0317)

    Belo Horizonte, Minas Gerais, 30110-934

    Study Coordinator, +55 31 35147195

    Recruiting

  • Hospital Mario Penna ( Site 0309)

    Belo Horizonte, Minas Gerais, 30380-472

    Study Coordinator, +551 31 3299-9543

    Recruiting

  • Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308)

    Bragança Paulista, São Paulo, 12916-542

    Study Coordinator, +55 11 98337-1381

    Recruiting

  • Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314)

    Curitiba, Paraná, 80440-220

    Study Coordinator, 5541991681411

    Recruiting

  • Clínica de Neoplasias Litoral ( Site 0305)

    Itajaí, Santa Catarina, 88301-220

    Study Coordinator, +5547984046243

    Recruiting

  • Obras Sociais Irma Dulce ( Site 0302)

    Salvador, Estado de Bahia, 41680-430

    Study Coordinator, +55 71 3310-1978

    Recruiting

  • A. C. Camargo Cancer Center ( Site 0310)

    São Paulo, São Paulo, 01509-010

    Active, not recruiting

  • Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320)

    Vitória, Espírito Santo, 29041-295

    Study Coordinator, +55 27 3334-8346

    Recruiting

Other trials in Brazil

Canada8 sites, 6 recruiting

  • Cross Cancer Institute ( Site 0332)

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator, 7804328762

    Recruiting

  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328)

    Greenfield Park, Quebec, J4V 2H1

    Study Coordinator, 4504665000 ext 3226

    Recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0326)

    Montreal, Quebec, H2X 3E4

    Active, not recruiting

  • The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336)

    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 0327)

    Québec, Quebec, G1J 1Z4

    Study Coordinator, 418 525-4444

    Recruiting

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329)

    Sherbrooke, Quebec, J1H 5H4

    Active, not recruiting

  • Sunnybrook Research Institute ( Site 0331)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 647-533-1023

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0330)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, (416) 946-4501

    Recruiting

Other trials in Canada

France8 sites, 7 recruiting

  • Centre Hospitalier de la Cote Basque ( Site 0633)

    Bayonne, Pyrenees-Atlantiques, 64109

    Study Coordinator, 33559443535

    Recruiting

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629)

    Clermont-Ferrand, Puy-de-Dome, 63003

    Study Coordinator, +33473278005

    Recruiting

  • Centre Oscar Lambret ( Site 0634)

    Lille, Ain, 59020

    Study Coordinator, +33320295959

    Recruiting

  • Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630)

    Nîmes, Gard, 30029

    Study Coordinator, +33466683301

    Recruiting

  • Hôpital Européen Georges Pompidou ( Site 0628)

    Paris, 75015

    Active, not recruiting

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632)

    Rennes, Ille-et-Vilaine, 35042

    Study Coordinator, +33299253182

    Recruiting

  • Hopitaux Universitaires de Strasbourg ( Site 0627)

    Strasbourg, Bas-Rhin, 67200

    Study Coordinator, +33368767207

    Recruiting

  • Gustave Roussy ( Site 0626)

    Villejuif, Val-de-Marne, 94800

    Study Coordinator, +33 1 42 11 42 11

    Recruiting

Other trials in France

Germany8 sites, 7 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679)

    Berlin, 10117

    Study Coordinator, 0049 30 450615285

    Recruiting

  • Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680)

    Bonn, North Rhine-Westphalia, 53127

    Study Coordinator, +4922828714249

    Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705)

    Hamburg, 20246

    Study Coordinator, +4915222815585

    Recruiting

  • Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682)

    Jena, Thuringia, 07747

    Study Coordinator, +49 3641 9 32 9947

    Recruiting

  • Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691)

    Lübeck, Schleswig-Holstein, 23538

    Study Coordinator, +4945150043699

    Recruiting

  • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696)

    Munich, Bavaria, 81675

    Active, not recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678)

    Münster, North Rhine-Westphalia, 48149

    Study Coordinator, 0049251-8344658

    Recruiting

  • HELIOS Kliniken Schwerin ( Site 0694)

    Schwerin, Mecklenburg-Vorpommern, 19055

    Study Coordinator, +493855202120

    Recruiting

Other trials in Germany

Argentina7 sites, 4 recruiting

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)

    Buenos Aires, Buenos Aires F.D., C1419AHN

    Study Coordinator, +5491145744343

    Recruiting

  • Instituto Alexander Fleming-Alexander Fleming ( Site 0206)

    Buenos Aires, Buenos Aires F.D., C1426ANZ

    Study Coordinator, +5491132218900

    Recruiting

  • Hospital Aleman-Oncology ( Site 0207)

    Buenos Aires, C1118AAT

    Active, not recruiting

  • Hospital Británico de Buenos Aires-Oncology ( Site 0202)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

    Active, not recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

    Mar del Plata, Buenos Aires, B7600FZO

    Active, not recruiting

  • Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204)

    Mendoza, M5500AYB

    Study Coordinator, +5492615449901

    Recruiting

  • Sanatorio Parque ( Site 0208)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +5493414200222

    Recruiting

Other trials in Argentina

Chile7 sites, 4 recruiting

  • Bradford Hill Norte ( Site 0357)

    Antofagasta, 1240000

    Study Coordinator, 56442023631

    Recruiting

  • IC La Serena Research ( Site 0356)

    La Serena, Coquimbo Region, 1720430

    Completed

  • Fundación Arturo López Pérez ( Site 0353)

    Santiago, Region M. de Santiago, 7500921

    Active, not recruiting

  • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354)

    Santiago, Region M. de Santiago, 8330024

    Study Coordinator, +56934331806

    Recruiting

  • Bradfordhill-Clinical Area ( Site 0351)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

  • Clinica Universidad Catolica del Maule-Oncology ( Site 0355)

    Talca, Maule Region, 3465584

    Study Coordinator, +56947532700

    Recruiting

  • Clinical Research Chile SpA ( Site 0358)

    Valdivia, Los Ríos Region, 5110683

    Active, not recruiting

Other trials in Chile

Poland7 sites, 4 recruiting

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1302)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Active, not recruiting

  • Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316)

    Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300

    Completed

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318)

    Kielce, Świętokrzyskie Voivodeship, 25-734

    Study Coordinator, +48413674811

    Recruiting

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, +48943488930

    Recruiting

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310)

    Siedlce, Masovian Voivodeship, 08-110

    Study Coordinator, +48256403301

    Recruiting

  • Zachodniopomorskie Centrum Onkologii ( Site 1311)

    Szczecin, West Pomeranian Voivodeship, 71-730

    Study Coordinator, +48914251502

    Recruiting

  • Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

    Completed

Other trials in Poland

Spain7 sites, 7 recruiting

  • Hospital Jerez de la Frontera ( Site 1427)

    Jerez de la Frontera, Cadiz, 11407

    Study Coordinator, +34661753582

    Recruiting

  • Hospital Lucus Augusti-Oncology ( Site 1432)

    Lugo, 27003

    Study Coordinator, +34982296459

    Recruiting

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431)

    Madrid, Madrid, Comunidad de, 28034

    Study Coordinator, 34913368263

    Recruiting

  • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433)

    Madrid, Madrid, Comunidad de, 28041

    Study Coordinator, 608464547

    Recruiting

  • Complexo Hospitalario Universitario de Ourense ( Site 1426)

    Ourense, Orense, 32005

    Study Coordinator, +34988385471

    Recruiting

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428)

    Seville, 41013

    Study Coordinator, 34955013068

    Recruiting

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430)

    Valencia, Valenciana, Comunitat, 46009

    Study Coordinator, +34 961114229

    Recruiting

Other trials in Spain

Colombia6 sites, 5 recruiting

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501)

    Bogotá, Bogota D.C., 111321

    Study Coordinator, 6017058333

    Recruiting

  • Fundación Valle del Lili ( Site 0505)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +573133288646

    Recruiting

  • Clínica Imbanaco S.A.S ( Site 0509)

    Cali, Valle del Cauca Department, 760042

    Completed

  • IMAT S.A.S ( Site 0504)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +573135342052

    Recruiting

  • Fundación Cardiovascular de Colombia ( Site 0503)

    Piedecuesta, Santander Department, 681017

    Study Coordinator, +573203400438

    Recruiting

  • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502)

    Valledupar, Cesar Department, 200001

    Study Coordinator, +57 3158505190

    Recruiting

Other trials in Colombia

Israel6 sites, 6 recruiting

  • Emek Medical Center ( Site 0830)

    Afula, 1834111

    Study Coordinator, 0546708579

    Recruiting

  • Rambam Health Care Campus-Oncology Division ( Site 0826)

    Haifa, 3109601

    Study Coordinator, 04-7776234

    Recruiting

  • Hadassah Medical Center ( Site 0833)

    Jerusalem, 9112001

    Study Coordinator, 02-6777111

    Recruiting

  • Meir Medical Center. ( Site 0832)

    Kfar Saba, 4428164

    Study Coordinator, 0503745684

    Recruiting

  • Rabin Medical Center ( Site 0828)

    Petah Tikva, 4941492

    Study Coordinator, 972-50-3745684

    Recruiting

  • Sheba Medical Center ( Site 0827)

    Ramat Gan, 5265601

    Study Coordinator, : +972-35302191

    Recruiting

Other trials in Israel

Mexico6 sites, 5 recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103)

    Guadalajara, Jalisco, 44630

    Study Coordinator, +52 3313587270

    Recruiting

  • Medical Care and Research SA de CV ( Site 1108)

    Mérida, Yucatán, 97070

    Completed

  • Quemex Medical and Research ( Site 1112)

    Mexico City, Mexico City, 14308

    Study Coordinator, +52555673461

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 1109)

    Mexico City, Mexico City, 68020

    Study Coordinator, +529515473137

    Recruiting

  • Filios Alta Medicina ( Site 1106)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528110623583

    Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 1107)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528183338111 Ext.9

    Recruiting

Other trials in Mexico

Peru6 sites, 3 recruiting

  • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258)

    Concepción, Departamento de Junín, 12125

    Study Coordinator, +51 958864658

    Recruiting

  • Aliada-Oncologìa ( Site 1257)

    Lima, 15036

    Active, not recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254)

    Lima, 15036

    Active, not recruiting

  • Oncosalud-Clinical Research ( Site 1260)

    Lima, 15036

    Active, not recruiting

  • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256)

    Lima, 15038

    Study Coordinator, +511 2016500

    Recruiting

  • Clínica Sánchez Ferrer ( Site 1261)

    Trujillo, La Libertad, 13009

    Study Coordinator, 948319999

    Recruiting

Other trials in Peru

United Kingdom6 sites, 6 recruiting

  • Addenbrooke's Hospital ( Site 1605)

    Cambridge, Cambridgeshire, CB2 2QQ

    Study Coordinator, 01223216083

    Recruiting

  • The Beatson West of Scotland Cancer Centre ( Site 1603)

    Glasgow, Glasgow City, G12 0YN

    Study Coordinator, +441413017000

    Recruiting

  • Charing Cross Hospital-Oncology Research ( Site 1606)

    London, Hammersmith and Fulham, W6 8RF

    Study Coordinator, 0208 331 10277

    Recruiting

  • University College London Hospital ( Site 1612)

    London, London, City of, NW1 2PG

    Study Coordinator, 0203 447 3042

    Recruiting

  • The Christie NHS Foundation Trust ( Site 1608)

    Manchester, m20 4bx

    Study Coordinator, +441614463000

    Recruiting

  • The Royal Cornwall Hospital ( Site 1610)

    Truro, England, TR1 3LJ

    Study Coordinator, 01872258345

    Recruiting

Other trials in United Kingdom

Australia5 sites, 5 recruiting

  • Princess Alexandra Hospital-Cancer Care Serices ( Site 0237)

    Brisbane, Queensland, 4102

    Study Coordinator, +6173176 9289

    Recruiting

  • Dubbo Hospital ( Site 0235)

    Dubbo, New South Wales, 2830

    Study Coordinator, 0268096200

    Recruiting

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 0234)

    Macquarie University, New South Wales, 2109

    Study Coordinator, 0298122979

    Recruiting

  • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230)

    Melbourne, Victoria, 3000

    Study Coordinator, 03 8559 5000

    Recruiting

  • Westmead Hospital ( Site 0232)

    Westmead, New South Wales, 2145

    Study Coordinator, +61288905555

    Recruiting

Other trials in Australia

Malaysia5 sites, 4 recruiting

  • Hospital Sultan Ismail ( Site 1081)

    Johor Bahru, Johor, 81100

    Study Coordinator, +6073565155

    Recruiting

  • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078)

    Kuala Lumpur, 50586

    Study Coordinator, +60326155810

    Recruiting

  • Sarawak General Hospital-Radiotherapy Unit ( Site 1076)

    Kuching, Sarawak, 93586

    Study Coordinator, +6082276820

    Recruiting

  • University Malaya Medical Centre ( Site 1077)

    Lembah Pantai, Kuala Lumpur, 59100

    Completed

  • National Cancer Institute ( Site 1079)

    Putrajaya, Putrajaya, 62250

    Study Coordinator, +60388925418

    Recruiting

Other trials in Malaysia

Taiwan5 sites, 5 recruiting

  • China Medical University Hospital-Department of Urology ( Site 1503)

    Taichung, 40447

    Study Coordinator, +886-4-2205-2121

    Recruiting

  • National Cheng Kung University Hospital-Urology ( Site 1502)

    Tainan, 704

    Study Coordinator, +886-6-2353535

    Recruiting

  • National Taiwan University Hospital-Urology ( Site 1506)

    Taipei, 10002

    Study Coordinator, +886-2-2312-3456

    Recruiting

  • Taipei Veterans General Hospital ( Site 1505)

    Taipei, 112

    Study Coordinator, +886-2-28712121

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504)

    Taoyuan, 333

    Study Coordinator, +886-3-3281200

    Recruiting

Other trials in Taiwan

Czechia4 sites, 3 recruiting

  • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553)

    Brno, Brno-mesto, 656 53

    Study Coordinator, +420 543 136 216

    Recruiting

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555)

    Olomouc, Olomouc Region, 779 00

    Study Coordinator, +420 588 444 699

    Recruiting

  • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554)

    Ostrava, Moravian-Silesian Region, 708 52

    Study Coordinator, +420597372264

    Recruiting

  • Fakultní nemocnice Motol a Homolka ( Site 0551)

    Prague, 150 06

    Active, not recruiting

Other trials in Czechia

Hungary4 sites, 4 recruiting

  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756)

    Budapest, Pest County, 1122

    Study Coordinator, +36122486001171

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758)

    Debrecen, 4032

    Study Coordinator, +3652411717

    Recruiting

  • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752)

    Kecskemét, Bács-Kiskun county, 6000

    Study Coordinator, +3676516719

    Recruiting

  • Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761)

    Salgótarján, Nógrád megye, 3100

    Study Coordinator, +3632522000

    Recruiting

Other trials in Hungary

South Korea4 sites, 4 recruiting

  • Seoul National University Hospital-Oncology ( Site 1401)

    Seoul, 03080

    Study Coordinator, +82220721672

    Recruiting

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404)

    Seoul, 03722

    Study Coordinator, +82222288138

    Recruiting

  • Samsung Medical Center ( Site 1405)

    Seoul, 06351

    Study Coordinator, +82234101767

    Recruiting

  • Asan Medical Center-Oncology ( Site 1402)

    Songpagu, Seoul, 05505

    Study Coordinator, +82230106095

    Recruiting

Other trials in South Korea

Thailand4 sites, 4 recruiting

  • Chulalongkorn University ( Site 1530)

    Bangkok, Bangkok, 10330

    Study Coordinator, +6622564533

    Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 1531)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624194489

    Recruiting

  • Songklanagarind hospital ( Site 1527)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Faculty of Medicine - Khon Kaen University ( Site 1526)

    Muang, Changwat Khon Kaen, 40002

    Study Coordinator, +66 43 366568-9

    Recruiting

Other trials in Thailand

Austria3 sites, 3 recruiting

  • Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280)

    Graz, Styria, 8036

    Study Coordinator, +4331638581307

    Recruiting

  • Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276)

    Linz, Upper Austria, 4020

    Study Coordinator, +4373276774724

    Recruiting

  • Klinikum Wels-Grieskirchen GmbH ( Site 0279)

    Wels, Upper Austria, 4600

    Study Coordinator, +4372424152328

    Recruiting

Other trials in Austria

Denmark3 sites, 2 recruiting

  • Rigshospitalet ( Site 0576)

    Copenhagen, Capital Region, 2100

    Study Coordinator, +45 35453545

    Recruiting

  • Odense Universitetshospital-Department of oncology ( Site 0579)

    Odense, Region Syddanmark, 5000

    Active, not recruiting

  • Vejle Sygehus ( Site 0578)

    Vejle, Region Syddanmark, 7100

    Study Coordinator, +45 79405000

    Recruiting

Other trials in Denmark

Finland3 sites, 2 recruiting

  • Kuopion Yliopistollinen Sairaala ( Site 0603)

    Kuopio, Northern Savonia, 70200

    Active, not recruiting

  • Tampereen yliopistollinen sairaala ( Site 0604)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, 358331166811

    Recruiting

  • Turku University Hospital-Department of Oncology ( Site 0601)

    Turku, Southwest Finland, 20520

    Study Coordinator, 35823130729

    Recruiting

Other trials in Finland

Italy3 sites, 3 recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879)

    Meldola, Emilia-Romagna, 47014

    Study Coordinator, +390543739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877)

    Milan, Lombardy, 20133

    Study Coordinator, 00390223903033

    Recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 0876)

    Milan, 20132

    Study Coordinator, +390226435668

    Recruiting

Other trials in Italy

Norway3 sites, 1 recruiting

  • Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227)

    Lørenskog, Akershus, 1474

    Study Coordinator, +4767963800

    Recruiting

  • Sykehuset Østfold Kalnes ( Site 1228)

    Sarpsborg, Østfold fylke, 1714

    Completed

  • St. Olavs Hospital-Kreftklinikken ( Site 1231)

    Trondheim, Sor-Trondelag, 7030

    Active, not recruiting

Other trials in Norway

Puerto Rico3 sites

  • Puerto Rico Medical Research Center LLC ( Site 1354)

    Hato Rey, 00917

    Completed

  • Ad-Vance Medical Research-Research ( Site 1353)

    Ponce, 00717

    Active, not recruiting

  • Pan American Center for Oncology Trials - Ciudadela ( Site 1351)

    San Juan, 00909

    Completed

Other trials in Puerto Rico

Singapore3 sites, 3 recruiting

  • National University Hospital ( Site 1376)

    Singapore, Central Singapore, 119074

    Study Coordinator, 6569082222

    Recruiting

  • National Cancer Centre Singapore ( Site 1377)

    Singapore, Central Singapore, 168583

    Study Coordinator, +65-64368000

    Recruiting

  • Tan Tock Seng Hospital-Medical Oncology ( Site 1378)

    Singapore, Central Singapore, 308433

    Study Coordinator, +65-62566011

    Recruiting

Other trials in Singapore

Sweden3 sites, 2 recruiting

  • Sahlgrenska Universitetssjukhuset ( Site 1479)

    Gothenburg, Västra Götaland County, 413 45

    Study Coordinator, 0046313421000

    Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 1478)

    Stockholm, Stockholm County, 171 64

    Active, not recruiting

  • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477)

    Uppsala, Uppsala County, 751 85

    Study Coordinator, 0046186110000

    Recruiting

Other trials in Sweden

Hong Kong2 sites

  • Queen Mary Hospital ( Site 0727)

    Hong Kong

    Active, not recruiting

  • Prince of Wales Hospital ( Site 0730)

    Shatin

    Active, not recruiting

Other trials in Hong Kong

Ireland2 sites, 2 recruiting

  • St. Vincent's University Hospital ( Site 0802)

    Dublin, Dublin, D04 T6F4

    Study Coordinator, +35312214000

    Recruiting

  • Tallaght University Hospital ( Site 0801)

    Dublin, D24 NR0A

    Study Coordinator, +35314144299

    Recruiting

Other trials in Ireland

New Zealand2 sites, 2 recruiting

  • Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203)

    Dunedin, Otago, 9016

    Study Coordinator, +64 3 470 9692

    Recruiting

  • Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201)

    Tauranga, Bay of Plenty, 3112

    Study Coordinator, +64277033845

    Recruiting

Other trials in New Zealand

About this study

Official title: A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

Being tested
Opevesostat, Abiraterone acetate, Enzalutamide, Hydrocortisone, Fludrocortisone acetate

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

  • Abiraterone acetateDrug

    Also called ZYTIGA, YONSA

    Administered orally

  • EnzalutamideDrug

    Also called XTANDI

    Administered orally

  • HydrocortisoneDrug

    Administered orally or IM as a rescue medication

  • Fludrocortisone acetateDrug

    Administered orally

  • PrednisoneDrug

    Administered orally as a rescue medication

  • DexamethasoneDrug

    Administered orally as rescue medication

Study groups in NCT06136624
Study groupRoleWhat they receive
OpevesostatExperimentalParticipants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular [IM]) dose will also be provided to participants for use as rescue medication. Prior to study protocol amendment 9, prednisone was provided as a rescue medication during adrenal recovery, titrated at 5mg daily maintenance dose and then titrated to discontinuation.
Receives: Drug: Opevesostat; Drug: Hydrocortisone; Drug: Fludrocortisone acetate; Drug: Prednisone; Drug: Dexamethasone
Abiraterone Acetate or EnzalutamideActive comparatorParticipants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.
Receives: Drug: Abiraterone acetate; Drug: Enzalutamide; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants

    OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-positive participants will be reported for each study arm.

    Measured: Up to ~54 months

  2. OS in AR LBD Mutation-Negative Participants

    OS is defined as time from randomization to death due to any cause. OS in AR LBD mutation-negative participants will be reported for each study arm.

    Measured: Up to ~54 months

Secondary outcomes (10)

  1. Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review in AR LBD Mutation-Positive Participants

    rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.

    Measured: Up to ~36 months

  2. rPFS Per Prostate Cancer Working Group-modifiedRECIST 1.1 as Assessed by Blinded Independent Central Review in AR LBD Mutation-Negative Participants

    rPFS is defined as the time from randomization to the first documented disease progression per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. rPFS in AR LBD mutation-positive participants will be reported for each study arm.

    Measured: Up to ~36 months

  3. Time to Initiation of the First Subsequent Anti-Cancer Therapy or Death (TFST)

    TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.

    Measured: Up to ~54 months

  4. Objective Response (OR)

    OR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.

    Measured: Up to ~54 months

  5. Duration of Response (DOR)

    DOR is determined by PCWG-modified RECIST 1.1 as assessed by BICR.

    Measured: Up to ~54 months

  6. Time to Pain Progression (TTPP)

    TTPP 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 ~54 months

  7. Time to Prostate-specific Antigen (PSA) Progression

    The time from randomization to PSA progression. The PSA progression date is defined as the date of either: 1) ≥25% increase and ≥2 ng/mL above the nadir, confirmed by a second value ≥3 weeks later if there is PSA decline from baseline 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.

    Measured: Up to ~54 months

  8. Time to First Symptomatic Skeletal-related Event (SSRE)

    The time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1) Use of EBRT to prevent or relieve skeletal symptoms; 2) new symptomatic pathologic bone fracture (vertebral or non-vertebral); 3) spinal cord compression; or 4) tumor-related orthopedic surgical intervention.

    Measured: Up to ~54 months

  9. Number of Participants Who Experience an Adverse Event

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to ~54 months

  10. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to ~54 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start31 Dec 2023
  3. Primary completion30 Nov 2028 (estimated)
  4. Study completion29 Mar 2030 (estimated)

Resources

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
1,310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136624
Sponsor's protocol ID
5684-003
Other IDs
2023-504899-25-00, MK-5684-003, jRCT2031240029, U1111-1287-5304, 2023
Acronym
OMAHA-003
Status last verified
Nov 2026
First submitted
13 Nov 2023
Last updated
5 Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Opevesostat, Abiraterone acetate and Enzalutamide in people with Prostate Cancer Metastatic, run by Merck Sharp & Dohme LLC at 288 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 288 sites in United States, China, Japan, Netherlands, Turkey (Türkiye) and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants (time frame: Up to ~54 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136624, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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