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

NCT06136624 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 5684-0032023-504899-25-00MK-5684-003jRCT2031240029U1111-1287-5304
• Study Type: interventional
• Target: 1,310
• Locations: 35 countries
• Sites: 279

Brief 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 (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.

Conditions

Prostate Cancer Metastatic

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to ~54 months

• 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.

  Up to ~54 months

Secondary Outcomes (10)

• 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

  Up to ~36 months

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

  Up to ~36 months

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

  Up to ~54 months

• Objective Response (OR)

  Up to ~54 months

• Duration of Response (DOR)

  Up to ~54 months

Study Arms (2)

Opevesostat

EXPERIMENTAL

Participants 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.

Drug: Opevesostat; Drug: Hydrocortisone; Drug: Fludrocortisone acetate; Drug: Dexamethasone

Abiraterone Acetate or Enzalutamide

ACTIVE COMPARATOR

Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.

Drug: Abiraterone acetate; Drug: Enzalutamide; Drug: Prednisone

Interventions

Opevesostat DRUG

Administered orally

Also known as: MK-5684

Opevesostat

Abiraterone acetate DRUG

Administered orally

Also known as: ZYTIGA, YONSA

Abiraterone Acetate or Enzalutamide

Enzalutamide DRUG

Administered orally

Also known as: XTANDI

Abiraterone Acetate or Enzalutamide

Hydrocortisone DRUG

Administered orally or IM as a rescue medication

Opevesostat

Fludrocortisone acetate DRUG

Administered orally

Opevesostat

Prednisone DRUG

Administered orally

Abiraterone Acetate or Enzalutamide

Dexamethasone DRUG

Administered orally as rescue medication

Opevesostat

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (282)

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

Orange, California, 92868, United States

ACTIVE NOT RECRUITING

Stanford Cancer Center ( Site 0036)

Palo Alto, California, 94304, United States

RECRUITING

Kaiser Permanente Riverside Medical Center ( Site 0099)

Riverside, California, 92505, United States

RECRUITING

Anschutz Cancer Pavilion ( Site 0046)

Aurora, Colorado, 80045, United States

RECRUITING

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

Highlands Ranch, Colorado, 80129, United States

RECRUITING

Colorado Clinical Research ( Site 0067)

Lakewood, Colorado, 80228, United States

ACTIVE NOT RECRUITING

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

Lone Tree, Colorado, 80124, United States

RECRUITING

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

New Haven, Connecticut, 06510, United States

RECRUITING

Florida Cancer Specialists - South ( Site 7003)

Fort Myers, Florida, 33901, United States

RECRUITING

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

Miami, Florida, 33125, United States

ACTIVE NOT RECRUITING

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

Miami, Florida, 33136, United States

RECRUITING

University of Illinois at Chicago ( Site 0105)

Chicago, Illinois, 60612, United States

RECRUITING

University of Chicago Medical Center ( Site 0045)

Chicago, Illinois, 60637, United States

RECRUITING

University of Iowa ( Site 0047)

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky Chandler Medical Center ( Site 0048)

Lexington, Kentucky, 40536, United States

ACTIVE NOT RECRUITING

Ochsner Clinic Foundation ( Site 0108)

New Orleans, Louisiana, 70121, United States

ACTIVE NOT RECRUITING

Baltimore Veterans Affairs Medical Center ( Site 0069)

Baltimore, Maryland, 21201, United States

RECRUITING

Greenebaum Comprehensive Cancer Center ( Site 0049)

Baltimore, Maryland, 21201, United States

RECRUITING

Henry Ford Hospital ( Site 0015)

Detroit, Michigan, 48202, United States

ACTIVE NOT RECRUITING

M Health Fairview Clinics and Surgery Center ( Site 0019)

Minneapolis, Minnesota, 55455, United States

RECRUITING

Metro-Minnesota Community Clinical Oncology ( Site 0014)

Saint Louis Park, Minnesota, 55416, United States

RECRUITING

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

St Louis, Missouri, 63110, United States

ACTIVE NOT RECRUITING

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

Omaha, Nebraska, 68105, United States

RECRUITING

Comprehensive Cancer Centers of Nevada ( Site 0010)

Las Vegas, Nevada, 89148, United States

RECRUITING

Atlantic Health System Morristown Medical Center ( Site 0115)

Morristown, New Jersey, 07960, United States

RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0033)

New Brunswick, New Jersey, 08901, United States

ACTIVE NOT RECRUITING

James J. Peters VA Medical Center ( Site 0088)

The Bronx, New York, 10468, United States

RECRUITING

University Hospitals Cleveland Medical Center ( Site 0043)

Cleveland, Ohio, 44106, United States

RECRUITING

Oregon Health and Science University ( Site 0028)

Portland, Oregon, 97239, United States

ACTIVE NOT RECRUITING

VA Portland Health Care System ( Site 0058)

Portland, Oregon, 97239, United States

RECRUITING

AHN Allegheny General Hospital ( Site 0001)

Pittsburgh, Pennsylvania, 15212, United States

ACTIVE NOT RECRUITING

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

Charleston, South Carolina, 29401, United States

ACTIVE NOT RECRUITING

Avera Cancer Institute - Pierre ( Site 0118)

Pierre, South Dakota, 57501, United States

RECRUITING

Avera Cancer Institute- Research ( Site 0094)

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Avera Cancer Institute - Yankton ( Site 0117)

Yankton, South Dakota, 57078, United States

RECRUITING

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Central/South Texas ( Site 8003)

Austin, Texas, 78731, United States

RECRUITING

Texas Oncology - DFW ( Site 8001)

Dallas, Texas, 75246, United States

ACTIVE NOT RECRUITING

Texas Oncology - Gulf Coast ( Site 8002)

The Woodlands, Texas, 77380, United States

RECRUITING

University of Virginia Health System ( Site 0054)

Charlottesville, Virginia, 22908, United States

RECRUITING

VCU Health Adult Outpatient Pavillion ( Site 0061)

Richmond, Virginia, 23219, United States

ACTIVE NOT RECRUITING

Blue Ridge Cancer Care ( Site 0004)

Roanoke, Virginia, 24014, United States

RECRUITING

Fred Hutchinson Cancer Center ( Site 0013)

Seattle, Washington, 98109, United States

RECRUITING

MEDICAL COLLEGE OF WISCONSIN ( Site 0020)

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hospital Británico de Buenos Aires-Oncology ( Site 0202)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Instituto Alexander Fleming-Alexander Fleming ( Site 0206)

Buenos Aires, Buenos Aires F.D., 1426ANZ, Argentina

RECRUITING

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)

Buenos Aires, Buenos Aires F.D., C1419AHN, Argentina

RECRUITING

Sanatorio Parque ( Site 0208)

Rosario, Santa Fe Province, S2000DVC, Argentina

RECRUITING

Hospital Aleman-Oncology ( Site 0207)

Buenos Aires, C1118AAT, Argentina

RECRUITING

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

Mendoza, M5500AYB, Argentina

ACTIVE NOT RECRUITING

Dubbo Hospital ( Site 0235)

Dubbo, New South Wales, 2830, Australia

RECRUITING

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

Macquarie University, New South Wales, 2109, Australia

RECRUITING

Westmead Hospital ( Site 0232)

Westmead, New South Wales, 2145, Australia

ACTIVE NOT RECRUITING

Princess Alexandra Hospital-Cancer Care Serices ( Site 0237)

Brisbane, Queensland, 4102, Australia

RECRUITING

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

Melbourne, Victoria, 3000, Australia

ACTIVE NOT RECRUITING

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

Graz, Styria, 8036, Austria

RECRUITING

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276)

Linz, Upper Austria, 4020, Austria

RECRUITING

Klinikum Wels-Grieskirchen GmbH ( Site 0279)

Wels, Upper Austria, 4600, Austria

RECRUITING

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

Vitória, Espírito Santo, 29041-295, Brazil

RECRUITING

Obras Sociais Irma Dulce ( Site 0302)

Salvador, Estado de Bahia, 40415-006, Brazil

ACTIVE NOT RECRUITING

Hospital Felicio Rocho ( Site 0317)

Belo Horizonte, Minas Gerais, 30110-934, Brazil

RECRUITING

Hospital Mario Penna ( Site 0309)

Belo Horizonte, Minas Gerais, 30380-472, Brazil

ACTIVE NOT RECRUITING

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

Curitiba, Paraná, 80440-220, Brazil

ACTIVE NOT RECRUITING

Clínica de Neoplasias Litoral ( Site 0305)

Itajaí, Santa Catarina, 88301-220, Brazil

RECRUITING

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

Bragança Paulista, São Paulo, 12916-542, Brazil

ACTIVE NOT RECRUITING

A. C. Camargo Cancer Center ( Site 0310)

São Paulo, São Paulo, 01509-010, Brazil

ACTIVE NOT RECRUITING

Cross Cancer Institute ( Site 0332)

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

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

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sunnybrook Research Institute ( Site 0331)

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Centre ( Site 0330)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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

Greenfield Park, Quebec, J4V 2H1, Canada

RECRUITING

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

Montreal, Quebec, H2X 3E4, Canada

ACTIVE NOT RECRUITING

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327)

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

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

Sherbrooke, Quebec, J1H 5H4, Canada

ACTIVE NOT RECRUITING

IC La Serena Research ( Site 0356)

La Serena, Coquimbo Region, 1720430, Chile

ACTIVE NOT RECRUITING

Clinical Research Chile SpA ( Site 0358)

Valdivia, Los Ríos Region, 5110683, Chile

ACTIVE NOT RECRUITING

Clinica Universidad Catolica del Maule-Oncology ( Site 0355)

Talca, Maule Region, 3465584, Chile

RECRUITING

FALP ( Site 0353)

Santiago, Region M. de Santiago, 7500921, Chile

ACTIVE NOT RECRUITING

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

Santiago, Region M. de Santiago, 8330024, Chile

RECRUITING

Bradfordhill-Clinical Area ( Site 0351)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Bradford Hill Norte ( Site 0357)

Antofagasta, 1240000, Chile

ACTIVE NOT RECRUITING

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

Hefei, Anhui, 230000, China

RECRUITING

Peking University First Hospital-Urology ( Site 0390)

Beijing, Beijing Municipality, 100034, China

RECRUITING

Beijing Friendship Hospital Affiliate of Capital University ( Site 0396)

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Cancer hospital-Urinary Surgery ( Site 0395)

Beijing, Beijing Municipality, 100142, China

RECRUITING

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

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Chongqing University Cancer Hospital ( Site 0416)

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Southwest Hospital of Third Military Medical University ( Site 0420)

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Chongqing Three Gorges Central Hospital's ( Site 0426)

Chongqing, Chongqing Municipality, 404100, China

RECRUITING

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

Fuzhou, Fujian, 350005, China

RECRUITING

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

Xiamen, Fujian, 361003, China

RECRUITING

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

Guangzhou, Guangdong, 510120, China

RECRUITING

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

Guangzhou, Guangdong, 511400, China

RECRUITING

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

Wuhan, Hubei, 430000, China

RECRUITING

Hubei Cancer Hospital-Urinary surgery ( Site 0406)

Wuhan, Hubei, 430079, China

RECRUITING

Hunan Cancer Hospital ( Site 0405)

Changsha, Hunan, 410013, China

RECRUITING

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

Huaian, Jiangsu, 223300, China

RECRUITING

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

Nanjing, Jiangsu, 210008, China

RECRUITING

Affiliated hospital of Jiangnan university ( Site 0434)

Wuxi, Jiangsu, 214122, China

RECRUITING

Jiangxi Cancer Hospital ( Site 0386)

Nanchang, Jiangxi, 330029, China

RECRUITING

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

Xi'an, Shaanxi, 710004, China

RECRUITING

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

Xi'an, Shaanxi, 710061, China

RECRUITING

Yantai Yuhuangding Hospital ( Site 0397)

Yantai, Shandong, 264099, China

RECRUITING

Zhongshan Hospital of Fudan University (0430)

Shanghai, Shangai, 200032, China

RECRUITING

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

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

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

Shanghai, Shanghai Municipality, 200041, China

RECRUITING

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

Chengdu, Sichuan, 500643, China

RECRUITING

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

Chengdu, Sichuan, 610041, China

RECRUITING

Nanchong Central Hospital-urology ( Site 0422)

Nanchong, Sichuan, 500643, China

RECRUITING

Suining Central Hospital ( Site 0437)

Suining, Sichuan, 629000, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital ( Site 0392)

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

The Second Hospital of Tianjin Medical University ( Site 0391)

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

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

Ürümqi, Xinjiang, 830000, China

RECRUITING

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

Kunming, Yunnan, 650033, China

RECRUITING

Yunnan Province Cancer Hospital ( Site 0418)

Kunming, Yunnan, 650107, China

RECRUITING

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

Hangzhou, Zhejiang, 310014, China

RECRUITING

Zhejiang Cancer Hospital ( Site 0435)

Hangzhou, Zhejiang, 310022, China

RECRUITING

The First Hospital of Jiaxing-urology ( Site 0380)

Jiaxing, Zhejiang, 314001, China

RECRUITING

The First Affiliated Hospital of Ningbo University ( Site 0383)

Ningbo, Zhejiang, 315010, China

RECRUITING

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

Wenzhou, Zhejiang, 325000, China

RECRUITING

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

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

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

Valledupar, Cesar Department, 200001, Colombia

RECRUITING

IMAT S.A.S ( Site 0504)

Montería, Departamento de Córdoba, 230002, Colombia

RECRUITING

Fundación Cardiovascular de Colombia ( Site 0503)

Piedecuesta, Santander Department, 681017, Colombia

RECRUITING

Fundación Valle del Lili ( Site 0505)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Clínica Imbanaco S.A.S ( Site 0509)

Cali, Valle del Cauca Department, 760042, Colombia

ACTIVE NOT RECRUITING

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

Brno, Brno-mesto, 656 53, Czechia

RECRUITING

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554)

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555)

Olomouc, Olomouc Region, 779 00, Czechia

RECRUITING

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551)

Prague, Praha 5, 150 06, Czechia

ACTIVE NOT RECRUITING

Rigshospitalet ( Site 0576)

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Odense Universitetshospital-Department of oncology ( Site 0579)

Odense, Region Syddanmark, 5000, Denmark

ACTIVE NOT RECRUITING

Vejle Sygehus ( Site 0578)

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

Kuopion Yliopistollinen Sairaala ( Site 0603)

Kuopio, Northern Savonia, 70210, Finland

RECRUITING

Tampereen yliopistollinen sairaala ( Site 0604)

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Turku University Hospital-Department of Oncology ( Site 0601)

Turku, Southwest Finland, 20520, Finland

RECRUITING

Centre Oscar Lambret (Site 0634)

Lille, Ain, 59020, France

RECRUITING

Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627)

Strasbourg, Alsace, 67200, France

RECRUITING

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

Nîmes, Gard, 30029, France

ACTIVE NOT RECRUITING

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

Rennes, Ille-et-Vilaine, 35042, France

RECRUITING

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

Clermont-Ferrand, Puy-de-Dome, 63003, France

RECRUITING

Centre Hospitalier de la Côte Basque ( Site 0633)

Bayonne, Pyrenees-Atlantiques, 64109, France

RECRUITING

Gustave Roussy ( Site 0626)

Villejuif, Val-de-Marne, 94800, France

RECRUITING

Hôpital Européen Georges Pompidou ( Site 0628)

Paris, 75015, France

RECRUITING

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

Munich, Bavaria, 81675, Germany

ACTIVE NOT RECRUITING

HELIOS Kliniken Schwerin ( Site 0694)

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

RECRUITING

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

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

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

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

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

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

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

Jena, Thuringia, 07747, Germany

RECRUITING

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679)

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705)

Hamburg, 20246, Germany

RECRUITING

Queen Mary Hospital ( Site 0727)

Hong Kong, Hong Kong

RECRUITING

Prince of Wales Hospital ( Site 0730)

Shatin, Hong Kong

RECRUITING

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

Kecskemét, Bács-Kiskun county, 6000, Hungary

RECRUITING

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

Salgótarján, Nógrád megye, 3100, Hungary

RECRUITING

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

Budapest, Pest County, 1122, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758)

Debrecen, 4032, Hungary

RECRUITING

St. Vincent's University Hospital ( Site 0802)

Dublin, Dublin, D04 T6F4, Ireland

RECRUITING

Tallaght University Hospital ( Site 0801)

Dublin, D24 NR0A, Ireland

RECRUITING

Emek Medical Center ( Site 0830)

Afula, 1834111, Israel

RECRUITING

Rambam Health Care Campus-Oncology Division ( Site 0826)

Haifa, 3109601, Israel

RECRUITING

Hadassah Medical Center ( Site 0833)

Jerusalem, 9112001, Israel

RECRUITING

Meir Medical Center. ( Site 0832)

Kfar Saba, 4428164, Israel

RECRUITING

Rabin Medical Center ( Site 0828)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 0827)

Ramat Gan, 5265601, Israel

RECRUITING

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

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

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

Milan, Lombardy, 20133, Italy

RECRUITING

Ospedale San Raffaele-Oncologia Medica ( Site 0876)

Milan, 20132, Italy

RECRUITING

Toho University Sakura Medical Center ( Site 0906)

Sakura, Chiba, 285-8741, Japan

RECRUITING

Ehime University Hospital ( Site 0918)

Tōon, Ehime, 791-0295, Japan

RECRUITING

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

Kitakyushu, Fukuoka, 807-8556, Japan

ACTIVE NOT RECRUITING

Kurume University Hospital ( Site 0920)

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Asahikawa Medical University Hospital ( Site 0901)

Asahikawa, Hokkaido, 078-8510, Japan

RECRUITING

Sapporo Medical University Hospital ( Site 0902)

Sapporo, Hokkaido, 060-8543, Japan

RECRUITING

Hokkaido University Hospital ( Site 0931)

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kobe University Hospital ( Site 0914)

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Kanazawa Medical University Hospital ( Site 0909)

Mukai-awagasaki, Ishikawa-ken, 920-0265, Japan

RECRUITING

Kagawa University Hospital ( Site 0917)

Kita, Kagawa-ken, 761-0701, Japan

RECRUITING

Yokohama City University Medical Center ( Site 0908)

Yokohama, Kanagawa, 232-0024, Japan

RECRUITING

National Hospital Organization Nagasaki Medical Center ( Site 0923)

Ōmura, Nagasaki, 856-8562, Japan

RECRUITING

Nara Medical University Hospital ( Site 0915)

Kashihara, Nara, 634-8522, Japan

ACTIVE NOT RECRUITING

Nanbu Tokushukai Hospital ( Site 0930)

Shimajiri, Okinawa, 901-0417, Japan

RECRUITING

Kansai Medical University Hospital ( Site 0912)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Bell Land General Hospital ( Site 0913)

Sakai, Osaka, 599-8247, Japan

RECRUITING

The University of Osaka Hospital ( Site 0911)

Suita, Osaka, 565-0871, Japan

RECRUITING

Saga-Ken Medical Centre Koseikan ( Site 0922)

Saga, Saga-ken, 840-8571, Japan

ACTIVE NOT RECRUITING

The Jikei University Hospital ( Site 0907)

Minato, Tokyo, 105-8471, Japan

ACTIVE NOT RECRUITING

Akita University Hospital ( Site 0904)

Akita, 010-8543, Japan

RECRUITING

Kyushu University Hospital ( Site 0919)

Fukuoka, 812-8582, Japan

RECRUITING

Fukushima Medical University Hospital ( Site 0933)

Fukushima, 960-1295, Japan

RECRUITING

Gifu University Hospital ( Site 0910)

Gifu, 501-1112, Japan

RECRUITING

Hiroshima University Hospital ( Site 0916)

Hiroshima, 734-8551, Japan

RECRUITING

Kagoshima University Hospital ( Site 0929)

Kagoshima, 890-8520, Japan

RECRUITING

National Hospital Organization Kumamoto Medical Center ( Site 0924)

Kumamoto, 860-0008, Japan

RECRUITING

Miyazaki Prefectural Miyazaki Hospital ( Site 0927)

Miyazaki, 880-8510, Japan

RECRUITING

University of Miyazaki Hospital ( Site 0926)

Miyazaki, 889-1692, Japan

RECRUITING

Nagano Municipal Hospital ( Site 0932)

Nagano, 381-8551, Japan

RECRUITING

National Hospital Organization Oita Medical Center ( Site 0925)

Ōita, 870-0263, Japan

ACTIVE NOT RECRUITING

Hospital Sultan Ismail ( Site 1081)

Johor Bahru, Johor, 81100, Malaysia

RECRUITING

University Malaya Medical Centre ( Site 1077)

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

ACTIVE NOT RECRUITING

National Cancer Institute ( Site 1079)

Putrajaya, Putrajaya, 62250, Malaysia

RECRUITING

Sarawak General Hospital-Radiotherapy Unit ( Site 1076)

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078)

Kuala Lumpur, 50586, Malaysia

RECRUITING

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

Guadalajara, Jalisco, 44630, Mexico

ACTIVE NOT RECRUITING

Quemex Medical and Research ( Site 1112)

Mexico City, Mexico City, 14308, Mexico

ACTIVE NOT RECRUITING

Filios Alta Medicina ( Site 1106)

Monterrey, Nuevo León, 64460, Mexico

ACTIVE NOT RECRUITING

Medical Care and Research SA de CV ( Site 1108)

Mérida, Yucatán, 97070, Mexico

ACTIVE NOT RECRUITING

Centro de Investigacion Clinica de Oaxaca ( Site 1109)

Oaxaca City, 68020, Mexico

ACTIVE NOT RECRUITING

Radboudumc-Medical Oncology ( Site 1152)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163)

Sittard-Geleen, Limburg, 6162 BG, Netherlands

ACTIVE NOT RECRUITING

VieCuri Medisch Centrum ( Site 1173)

Venlo, Limburg, 5912 BL, Netherlands

ACTIVE NOT RECRUITING

ETZ Elisabeth-Internal Medicine ( Site 1160)

Tilburg, North Brabant, 5022 GC, Netherlands

RECRUITING

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

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Amsterdam UMC, locatie VUmc ( Site 1156)

Amsterdam, North Holland, 1081 HV, Netherlands

ACTIVE NOT RECRUITING

Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170)

Hoofddorp, North Holland, 2134 TM, Netherlands

RECRUITING

Medische Centrum Leeuwarden ( Site 1172)

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151)

Schiedam, South Holland, 3118 JH, Netherlands

RECRUITING

Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164)

The Hague, South Holland, 2545 AA, Netherlands

RECRUITING

Meander Medisch Centrum ( Site 1157)

Amersfoort, Utrecht, 3813TZ, Netherlands

RECRUITING

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

Tauranga, Bay of Plenty, 3112, New Zealand

RECRUITING

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

Dunedin, Otago, 9016, New Zealand

RECRUITING

Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227)

Lørenskog, Akershus, 1474, Norway

RECRUITING

St. Olavs Hospital-Kreftklinikken ( Site 1231)

Trondheim, Sor-Trondelag, 7030, Norway

ACTIVE NOT RECRUITING

Sykehuset Østfold Kalnes ( Site 1228)

Sarpsborg, Østfold fylke, 1714, Norway

ACTIVE NOT RECRUITING

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

Concepción, Departamento de Junín, 12125, Peru

RECRUITING

Clínica Sánchez Ferrer ( Site 1261)

Trujillo, La Libertad, 13009, Peru

RECRUITING

Aliada-Oncologìa ( Site 1257)

Lima, 15036, Peru

ACTIVE NOT RECRUITING

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

Lima, 15036, Peru

ACTIVE NOT RECRUITING

Oncosalud-Clinical Research ( Site 1260)

Lima, 15036, Peru

ACTIVE NOT RECRUITING

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

Lima, 15038, Peru

RECRUITING

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

RECRUITING

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

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

RECRUITING

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

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

ACTIVE NOT RECRUITING

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

Siedlce, Masovian Voivodeship, 08-110, Poland

RECRUITING

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

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

RECRUITING

Zachodniopomorskie Centrum Onkologii ( Site 1311)

Szczecin, West Pomeranian Voivodeship, 71-730, Poland

RECRUITING

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

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

RECRUITING

Puerto Rico Medical Research Center LLC ( Site 1354)

Hato Rey, 00917, Puerto Rico

ACTIVE NOT RECRUITING

Ad-Vance Medical Research-Research ( Site 1353)

Ponce, 00717, Puerto Rico

RECRUITING

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

San Juan, 00909, Puerto Rico

ACTIVE NOT RECRUITING

National University Hospital ( Site 1376)

Singapore, Central Singapore, 119074, Singapore

RECRUITING

National Cancer Centre Singapore ( Site 1377)

Singapore, Central Singapore, 168583, Singapore

RECRUITING

Tan Tock Seng Hospital-Medical Oncology ( Site 1378)

Singapore, Central Singapore, 308433, Singapore

RECRUITING

Asan Medical Center-Oncology ( Site 1402)

Songpagu, Seoul, 05505, South Korea

ACTIVE NOT RECRUITING

Seoul National University Hospital-Oncology ( Site 1401)

Seoul, 03080, South Korea

RECRUITING

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

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center ( Site 1405)

Seoul, 06351, South Korea

RECRUITING

Hospital Jerez de la Frontera ( Site 1427)

Jerez de la Frontera, Cadiz, 11407, Spain

RECRUITING

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

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

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

Madrid, Madrid, Comunidad de, 28041, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense ( Site 1426)

Ourense, Orense, 32005, Spain

RECRUITING

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430)

Valencia, Valenciana, Comunitat, 46009, Spain

RECRUITING

Hospital Lucus Augusti-Oncology ( Site 1432)

Lugo, 27003, Spain

RECRUITING

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

Seville, 41013, Spain

RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 1478)

Stockholm, Stockholm County, 171 64, Sweden

ACTIVE NOT RECRUITING

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477)

Uppsala, Uppsala County, 751 85, Sweden

RECRUITING

Sahlgrenska Universitetssjukhuset ( Site 1479)

Gothenburg, Västra Götaland County, 413 45, Sweden

RECRUITING

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

Taichung, 40447, Taiwan

RECRUITING

National Cheng Kung University Hospital-Urology ( Site 1502)

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital-Urology ( Site 1506)

Taipei, 10002, Taiwan

ACTIVE NOT RECRUITING

Taipei Veterans General Hospital ( Site 1505)

Taipei, 112, Taiwan

RECRUITING

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

Taoyuan, 333, Taiwan

RECRUITING

Chulalongkorn University ( Site 1530)

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 1531)

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 1526)

Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Songklanagarind hospital ( Site 1527)

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

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

Adana, 01250, Turkey (Türkiye)

RECRUITING

Gulhane Egitim Arastirma Hastanesi ( Site 1558)

Ankara, 06010, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Memorial Ankara Hastanesi-Medical Oncology ( Site 1557)

Ankara, 06520, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555)

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

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

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Samsun Medical Park Hastanesi-medical oncology (1560)

Samsun, 55200, Turkey (Türkiye)

RECRUITING

Addenbrooke's Hospital ( Site 1605)

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

RECRUITING

The Royal Cornwall Hospital ( Site 1610)

Truro, England, TR1 3LJ, United Kingdom

RECRUITING

The Beatson West of Scotland Cancer Centre ( Site 1603)

Glasgow, Glasgow City, G12 0YN, United Kingdom

RECRUITING

Charing Cross Hospital-Oncology Research ( Site 1606)

London, Hammersmith and Fulham, W6 8RF, United Kingdom

RECRUITING

University College London Hospital ( Site 1612)

London, London, City of, NW1 2PG, United Kingdom

ACTIVE NOT RECRUITING

The Christie NHS Foundation Trust ( Site 1608)

Manchester, m20 4bx, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 41732008 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Interventions

Abiraterone Acetate; enzalutamide; Hydrocortisone; fludrocortisone acetate; Prednisone; Dexamethasone

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienediols; Pregnadienes; Pregnadienetriols; Steroids, Fluorinated

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: December 31, 2023
• Primary Completion (Estimated): August 2, 2028
• Study Completion (Estimated): February 15, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

NL (11); NO (3); ES (7); PL (7); PE (6); AR (7); CA (8); SE (3); CN (39); GB (6); IL (6); AU (5); DK (3); NZ (2); HK (2); IE (2); BR (8); SG (3); TU (8); JP (30); FR (8); CZ (4); US (44); HU (4); FI (3); KR (4); MY (5); PR (3); IT (3); TH (4); CO (6); TW (5); ME (5); DE (8); CL (7)