A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

NCT06925737 | Recruiting Phase 3 DMC FDA Drug

• 4 other identifiers: 2400-001U1111-1312-24982024-517423-40-00MK-2400-001
• Study Type: interventional
• Target: 1,440
• Locations: 33 countries
• Sites: 274

Brief Summary

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.

Conditions

Prostate Cancer; Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  OS is defined as the time from randomization to death due to any cause.

  Up to approximately 36 months

• Radiographic Progression Free Survival (rPFS)

  rPFS is defined as the time from randomization to the first documented disease progression per prostate cancer working group (PCWG)-modifed Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first.

  Up to approximately 36 months

Secondary Outcomes (9)

• Time to First Subsequent Therapy (TFST)

  Up to approximately 36 months

• Objective Response Rate (ORR)

  Up to approximately 36 months

• Duration of Response (DOR)

  Up to approximately 36 months

• Time to Pain Progression (TTPP)

  Up to approximately 36 months

• Time to Prostate-specific Antigen (PSA) Progression

  Up to approximately 36 months

Study Arms (2)

I-DXd

EXPERIMENTAL

Participants receive I-DXd 12mg/kg every 3 weeks (q3w)

Drug: Ifinatamab deruxtecan; Drug: Rescue Medication

Docetaxel

ACTIVE COMPARATOR

Participants receive docetaxel 75 mg/m\^2 q3w and prednisone 10 mg/day or per approved product label

Drug: Docetaxel; Drug: Prednisone

Interventions

Ifinatamab deruxtecan DRUG

Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Also known as: I-DXd, MK-2400, DS-7300a

I-DXd

Docetaxel DRUG

Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Docetaxel

Prednisone DRUG

Oral tablet administered once per day or per approved product label

Also known as: Prednisone acetate, Prednisolone, Prednisolone acetate

Docetaxel

Rescue Medication DRUG

Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label

Also known as: 5-HT3 receptor antagonist, NK-1 receptor antagonist, Corticosteroid

I-DXd

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: 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 (ADT) (or post bilateral orchiectomy) within 6 months prior to 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 (CT)/magnetic resonance imaging (MRI)
• Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
• Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
• Has recovered from adverse events (AEs) due to previous anticancer therapies

You may not qualify if:

• Is unable to swallow tablets/capsules
• Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:
• Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
• Has current ILD/pneumonitis
• Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
• Has uncontrolled or significant cardiovascular disease
• Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
• Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
• Has a "superscan" bone scan

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (279)

Mayo Clinic in Arizona - Phoenix ( Site 0044)

Phoenix, Arizona, 85054, United States

RECRUITING

City of Hope Comprehensive Cancer Center ( Site 0049)

Duarte, California, 91010, United States

RECRUITING

City of Hope Lennar Foundation Cancer Center ( Site 0059)

Irvine, California, 92618, United States

RECRUITING

Moores Cancer Center ( Site 0010)

La Jolla, California, 92093, United States

RECRUITING

Cedars-Sinai Medical Center ( Site 0068)

Los Angeles, California, 90048, United States

RECRUITING

UCLA Hematology/Oncology - Santa Monica ( Site 0002)

Los Angeles, California, 90404, United States

RECRUITING

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)

Orange, California, 92868, United States

RECRUITING

Stanford Cancer Center ( Site 0046)

Palo Alto, California, 94304, United States

RECRUITING

Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)

Aurora, Colorado, 80045, United States

RECRUITING

Yale-New Haven Hospital-Yale Cancer Center ( Site 0050)

New Haven, Connecticut, 06510, United States

RECRUITING

Veterans Affairs Connecticut Healthcare System ( Site 0062)

West Haven, Connecticut, 06516, United States

RECRUITING

The GW Medical Faculty Associates ( Site 0057)

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Washington DC Veterans Affairs Medical Center ( Site 0056)

Washington D.C., District of Columbia, 20422, United States

RECRUITING

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)

Jacksonville, Florida, 32224, United States

RECRUITING

Emory University School of Medicine- Grady Campus ( Site 0103)

Atlanta, Georgia, 30303, United States

RECRUITING

Winship Cancer Institute, Emory University ( Site 0003)

Atlanta, Georgia, 30322, United States

RECRUITING

University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)

Chicago, Illinois, 60612, United States

RECRUITING

University of Kentucky Chandler Medical Center ( Site 0048)

Lexington, Kentucky, 40536, United States

RECRUITING

Greenebaum Comprehensive Cancer Center ( Site 0021)

Baltimore, Maryland, 21201, United States

RECRUITING

Beth Israel Deaconess Medical Center ( Site 0043)

Boston, Massachusetts, 02215, United States

RECRUITING

Dana Farber Cancer Institute ( Site 0012)

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan ( Site 0005)

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Hospital ( Site 0035)

Detroit, Michigan, 48202, United States

RECRUITING

Cancer and Hematology Centers of Western Michigan ( Site 0015)

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078)

Rochester, Minnesota, 55905, United States

RECRUITING

HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)

Saint Louis Park, Minnesota, 55426, United States

RECRUITING

HealthPartners Cancer Center at Regions Hospital ( Site 0052)

Saint Paul, Minnesota, 55101, United States

RECRUITING

St. Vincent Frontier Cancer Center-Research ( Site 0037)

Billings, Montana, 59102, United States

RECRUITING

Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)

Grand Island, Nebraska, 68803, United States

RECRUITING

Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)

Omaha, Nebraska, 68130, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)

Hackensack, New Jersey, 07601, United States

RECRUITING

University of New Mexico Comprehensive Cancer Center ( Site 0022)

Albuquerque, New Mexico, 87131, United States

RECRUITING

Icahn School of Medicine at Mount Sinai ( Site 0009)

New York, New York, 10029, United States

RECRUITING

Great Lakes Cancer Care ( Site 0047)

Williamsville, New York, 14221, United States

RECRUITING

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061)

Columbus, Ohio, 43221, United States

RECRUITING

VA Portland Health Care System ( Site 0038)

Portland, Oregon, 97239, United States

RECRUITING

Perelman Center for Advanced Medicine ( Site 0067)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Abramson Cancer Center - Penn Medicine ( Site 0079)

Philadelphia, Pennsylvania, 19106, United States

RECRUITING

Memphis VA Medical Center ( Site 0072)

Memphis, Tennessee, 38105, United States

RECRUITING

SCRI Oncology Partners ( Site 0074)

Nashville, Tennessee, 37203, United States

RECRUITING

UT Southwestern Medical Center ( Site 0039)

Dallas, Texas, 75390, United States

RECRUITING

University of Texas-MD Anderson Cancer Center ( Site 0055)

Houston, Texas, 77030, United States

RECRUITING

Blue Ridge Cancer Care ( Site 0024)

Roanoke, Virginia, 24014, United States

RECRUITING

VA Puget Sound Health Care System ( Site 0054)

Seattle, Washington, 98108, United States

RECRUITING

Fred Hutchinson Cancer Center ( Site 0060)

Seattle, Washington, 98109, United States

RECRUITING

University Hospital and UW Health Clinics ( Site 0065)

Madison, Wisconsin, 53792, United States

RECRUITING

Medical College of Wisconsin ( Site 0008)

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)

Berazategui, Buenos Aires, B1884BBF, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0129)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Instituto Alexander Fleming ( Site 0125)

Mar del Plata, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Sanatorio Parque ( Site 0126)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

Centro Medico Dra De Salvo ( Site 0132)

CABA, C1426ABP, Argentina

RECRUITING

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0131)

La Rioja, F5300COE, Argentina

RECRUITING

Centro Oncologico de Integracion Regional. COIR ( Site 0130)

Mendoza, M5500AYB, Argentina

RECRUITING

Centro de Diagnostico Investigación y Tratamiento Oncológico (CeDIT) ( Site 0135)

Salta, A4400AWG, Argentina

RECRUITING

Instituto San Marcos ( Site 0137)

San Juan, J5400EBB, Argentina

RECRUITING

Blacktown Hospital ( Site 0154)

Blacktown, New South Wales, 2148, Australia

RECRUITING

Macquarie University-MQ Health Clinical Trials Unit ( Site 0151)

Macquarie University, New South Wales, 2109, Australia

RECRUITING

Gallipoli Medical Research Ltd ( Site 0153)

Greenslopes, Queensland, 4120, Australia

RECRUITING

Peter MacCallum Cancer Centre ( Site 0152)

Melbourne, Victoria, 3000, Australia

RECRUITING

Fiona Stanley Hospital ( Site 0155)

Murdock, Western Australia, 6150, Australia

RECRUITING

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0170)

Linz, Upper Austria, 4020, Austria

RECRUITING

Klinikum Wels-Grieskirchen GmbH ( Site 0171)

Wels, Upper Austria, 4600, Austria

RECRUITING

Uniklinikum Salzburg Universitaetsklinik für Innere Medizin III ( Site 0172)

Salzburg, 5020, Austria

RECRUITING

Hospital Mario Penna ( Site 0179)

Belo Horizonte, Minas Gerais, 30380-472, Brazil

RECRUITING

Hospital Universitário Evangélico Mackenzie ( Site 0181)

Curitiba, Paraná, 80730-150, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0184)

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Hospital de Base de São José do Rio Preto ( Site 0176)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

IPITEC ( Site 0189)

São Paulo, 01221-020, Brazil

RECRUITING

IBCC - Núcleo de Pesquisa e Ensino ( Site 0183)

São Paulo, 04014-012, Brazil

RECRUITING

FALP ( Site 0201)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Bradfordhill ( Site 0200)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Peking University First Hospital ( Site 1434)

Beijing, Beijing Municipality, 100034, China

RECRUITING

Shanghai General Hospital ( Site 1449)

Beijing, Beijing Municipality, 200080, China

RECRUITING

The First Affiliated Hospital of Chonqing Medical University ( Site 1406)

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Chongqing University Three Gorges Hospital ( Site 1405)

Chongqing, Chongqing Municipality, 404199, China

RECRUITING

The First Affiliated Hospital Of Fujian Medical University ( Site 1452)

Fuzhou, Fujian, 350005, China

RECRUITING

Guangzhou First People's Hospital ( Site 1410)

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-Sen University Cancer Center ( Site 1467)

Guangzhou, Guangdong, 510060, China

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 1402)

Guangzhou, Guangdong, 510220, China

RECRUITING

Sun Yat-sen University Cancer Center ( Site 1409)

Guangzhou, Guangdong, 510300, China

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 1459)

Zhuhai, Guangdong, 51900, China

RECRUITING

Guangxi Medical University Cancer Hospital ( Site 1414)

Nanning, Guangxi, 530201, China

RECRUITING

Henan Cancer Hospital ( Site 1472)

Zhengzhou, Henan, 450008, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1424)

Wuhan, Hubei, 430022, China

RECRUITING

Hunan Cancer Hospital ( Site 1411)

Changsha, Hunan, 410013, China

RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 1425)

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Province Hospital ( Site 1426)

Nanjing, Jiangsu, 210029, China

RECRUITING

Zhongda Hospital Southeast University ( Site 1427)

Nanjing, Jiangsu, 214023, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University ( Site 1438)

Xuzhou, Jiangsu, 221006, China

RECRUITING

Jilin Province People's Hospital ( Site 1461)

Changchun, Jilin, 130021, China

RECRUITING

The first affiliated Hospital of Xi an Jiaotong University ( Site 1408)

Xi'an, Shaanxi, 710061, China

RECRUITING

Shandong Cancer Hospital ( Site 1421)

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Tenth People's Hospital ( Site 1441)

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Fudan University Shanghai Cancer Center ( Site 1400)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Zhongshan Hospital Fudan University ( Site 1430)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Tongji Hospital ( Site 1412)

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1457)

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

First Affiliated Hospital Of Shanxi Medical University ( Site 1460)

Taiyuan, Shanxi, 030001, China

RECRUITING

West China Hospital of Sichuan University ( Site 1451)

Chengdu, Sichuan, 610041, China

RECRUITING

West China Hospital, Sichuan University ( Site 1468)

Chengdu, Sichuan, 610041, China

RECRUITING

The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 1469)

Ürümqi, Xinjiang, 830000, China

RECRUITING

Zhejiang Cancer Hospital ( Site 1447)

Hangzhou, Zhejiang, 310005, China

RECRUITING

The First Hospital of Jiaxing ( Site 1416)

Jiaxing, Zhejiang, 314001, China

RECRUITING

The First Affiliated Hospital of Ningbo University ( Site 1419)

Ningbo, Zhejiang, 315010, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University ( Site 1437)

Wenzhou, Zhejiang, 325000, China

RECRUITING

Instituto de Cancerología S.A.S ( Site 0234)

Medellín, Antioquia, 050025, Colombia

RECRUITING

Centro Cancerológico del Caribe (CECAC) ( Site 0227)

Barranquilla, Atlántico, 080002, Colombia

RECRUITING

Instituto Nacional De Cancerologia ( Site 0237)

Bogotá, Bogota D.C., 110411, Colombia

RECRUITING

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0229)

Bogotá, Bogota D.C., 111321, Colombia

RECRUITING

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0228)

Valledupar, Cesar Department, 200001, Colombia

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0230)

Bogota, Cundinamarca, 110111, Colombia

RECRUITING

Oncologos Del Occidente ( Site 0231)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Fakultni nemocnice u sv. Anny v Brne ( Site 0264)

Brno, Brno-mesto, 602 00, Czechia

RECRUITING

Masarykuv onkologicky ustav ( Site 0260)

Brno, Brno-mesto, 656 53, Czechia

RECRUITING

Fakultni nemocnice Ostrava ( Site 0263)

Ostrava - Poruba, Moravskoslezský kraj, 708 52, Czechia

RECRUITING

Fakultni Nemocnice v Motole ( Site 0261)

Prague, Praha 5, 150 06, Czechia

RECRUITING

Fakultni nemocnice Olomouc ( Site 0262)

Olomouc, 779 00, Czechia

RECRUITING

Herlev and Gentofte Hospital ( Site 0290)

Herlev, Capital Region, 2370, Denmark

RECRUITING

Aalborg Universitetshospital, Syd ( Site 0293)

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Odense Universitetshospital ( Site 0294)

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Vejle Sygehus ( Site 0291)

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

Hôpital Foch ( Site 0309)

Suresnes, Ain, 92151, France

RECRUITING

Hôpital Privé Clairval ( Site 0303)

Marseille, Bouches-du-Rhone, 13273, France

RECRUITING

Centre François Baclesse ( Site 0311)

Caen, Calvados, 14076, France

RECRUITING

CHU Besançon ( Site 0305)

Besançon, Doubs, 25000, France

SUSPENDED

Centre Hospitalier Universitaire de Nîmes - Institut de Canc-Medical Oncology ( Site 0313)

Nîmes, Gard, 30029, France

RECRUITING

Clinique Francois Chenieux ( Site 0312)

Limoges, Haute-Vienne, 87039, France

RECRUITING

Institut de Cancérologie de Lorraine Alexis Vautrin ( Site 0307)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54519, France

RECRUITING

CHU de Rouen ( Site 0301)

Rouen, Seine-Maritime, 76031, France

RECRUITING

Hôpital Saint-Louis ( Site 0310)

Paris, Île-de-France Region, 75010, France

RECRUITING

Studienpraxis Urologie ( Site 0358)

Nürtingen, Baden-Wurttemberg, 72622, Germany

RECRUITING

Klinikum Stuttgart - Katharinenhospital ( Site 0355)

Stuttgart, Baden-Wurttemberg, 70174, Germany

RECRUITING

klinikum rechts der isar der technischen universität münchen ( Site 0350)

Munich, Bavaria, 81675, Germany

RECRUITING

Klinikum Nuernberg Nord ( Site 0353)

Nuremberg, Bavaria, 90419, Germany

RECRUITING

Universitätsklinikum Frankfurt Goethe-Universität ( Site 0354)

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Urologicum Duisburg ( Site 0361)

Duisburg, North Rhine-Westphalia, 47169, Germany

RECRUITING

Universitaetsklinikum Schleswig Holstein ( Site 0360)

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0352)

Berlin, 10117, Germany

RECRUITING

Universitaetsklinik Hamburg-Eppendorf ( Site 0351)

Hamburg, 20246, Germany

RECRUITING

Henry Dunant Hospital ( Site 0385)

Athens, Attica, 115 26, Greece

RECRUITING

Metropolitan General Hospital ( Site 0382)

Athens, Attica, 155 62, Greece

RECRUITING

University General Hospital Attikon ( Site 0381)

Chaidari Athens, Attica, 124 62, Greece

RECRUITING

General Oncology Hospital of Kifisia "Agioi Anargyroi" ( Site 0384)

Kifissia, Attica, 145 64, Greece

RECRUITING

Athens Medical Center ( Site 0383)

Marousi, Attica, 151 25, Greece

RECRUITING

MEDI-K ( Site 0401)

Guatemala City, 01009, Guatemala

RECRUITING

Med Clinic ( Site 0403)

Guatemala City, 01010, Guatemala

RECRUITING

Onco Go ( Site 0402)

Guatemala City, 01010, Guatemala

RECRUITING

Queen Mary Hospital ( Site 0415)

Hong Kong, Hong Kong

RECRUITING

Tuen Mun Hospital ( Site 0416)

New Territories, Hong Kong

RECRUITING

St Vincent's University Hospital ( Site 0441)

Dublin, Dublin, D04 T6F4, Ireland

RECRUITING

Cork University Hospital ( Site 0442)

Cork, T12 E8YV, Ireland

RECRUITING

Tallaght University Hospital ( Site 0440)

Dublin, D24 NR0A, Ireland

RECRUITING

Rambam Health Care Campus ( Site 0462)

Haifa, 3109601, Israel

RECRUITING

Meir Medical Center ( Site 0464)

Kfar Saba, 4428164, Israel

RECRUITING

Rabin Medical Center ( Site 0461)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 0460)

Ramat Gan, 5265601, Israel

RECRUITING

Sourasky Medical Center ( Site 0463)

Tel Aviv, 6423906, Israel

RECRUITING

Yitzhak Shamir Medical Center. ( Site 0466)

Ẕerifin, 7033001, Israel

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0500)

Milan, Lombardy, 20133, Italy

RECRUITING

Istituto Clinico Humanitas ( Site 0504)

Rozzano, Milano, 20089, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena ( Site 0507)

Rome, Roma, 00128, Italy

RECRUITING

Azienda Ospedaliero Universitaria Senese ( Site 0505)

Siena, Tuscany, 53100, Italy

RECRUITING

Azienda USL 8 di Arezzo ( Site 0503)

Arezzo, 52100, Italy

RECRUITING

Humanitas Gavazzeni ( Site 0508)

Bergamo, 24125, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0510)

Foggia, 71122, Italy

RECRUITING

Azienda Ospedaliera Santa Maria Terni ( Site 0509)

Terni, 05100, Italy

RECRUITING

Centro Ricerche Cliniche di Verona ( Site 0506)

Verona, 37134, Italy

RECRUITING

Nagoya University Hospital ( Site 1508)

Nagoya, Aichi-ken, 466-8560, Japan

RECRUITING

Toho University Sakura Medical Center ( Site 1503)

Sakura, Chiba, 285-8741, Japan

RECRUITING

Ehime University Hospital ( Site 1514)

Tōon, Ehime, 791-0295, Japan

RECRUITING

Hospital of the University of Occupational and Environmental Health, Japan ( Site 1510)

Kitakyushu, Fukuoka, 807-8556, Japan

RECRUITING

Kurume University Hospital ( Site 1516)

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Sapporo Medical University Hospital ( Site 1501)

Sapporo, Hokkaido, 060-8543, Japan

RECRUITING

Hokkaido University Hospital ( Site 1500)

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Kobe University Hospital ( Site 1511)

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Kanazawa Medical University Hospital ( Site 1507)

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

RECRUITING

Shonan Kamakura General Hospital ( Site 1530)

Kamakura, Kanagawa, 247-8533, Japan

RECRUITING

Oita University Hospital ( Site 1521)

Yufu, Oita Prefecture, 879-5593, Japan

RECRUITING

University of the Ryukyus Hospital ( Site 1519)

Ginowan, Okinawa, 901-2725, Japan

RECRUITING

Bell Land General Hospital ( Site 1509)

Sakai, Osaka, 599-8247, Japan

RECRUITING

Dokkyo Medical University Saitama Medical Center ( Site 1502)

Koshigaya, Saitama, 343-8555, Japan

RECRUITING

Hamamatsu University Hospital ( Site 1520)

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

The Jikei University Hospital ( Site 1504)

Minato, Tokyo, 105-8471, Japan

RECRUITING

Tokyo Women's Medical University ( Site 1505)

Shinjuku, Tokyo, 162-8666, Japan

ACTIVE NOT RECRUITING

Yamaguchi University Hospital ( Site 1522)

Ube, Yamaguchi, 755-8505, Japan

RECRUITING

University of Yamanashi Hospital ( Site 1506)

Chūō, Yamanashi, 409-3898, Japan

RECRUITING

Harasanshin Hospital ( Site 1517)

Fukuoka, 812-0033, Japan

RECRUITING

Kyushu University Hospital ( Site 1515)

Fukuoka, 812-8582, Japan

RECRUITING

Gifu University Hospital ( Site 1527)

Gifu, 501-1194, Japan

RECRUITING

Hiroshima University Hospital ( Site 1512)

Hiroshima, 734-8551, Japan

RECRUITING

Kagoshima University Hospital ( Site 1518)

Kagoshima, 890-8520, Japan

RECRUITING

Kagoshima City Hospital ( Site 1528)

Kagoshima, 890-8760, Japan

RECRUITING

National Hospital Organization Kumamoto Medical Center ( Site 1524)

Kumamoto, 860-0008, Japan

RECRUITING

University Hospital,Kyoto Prefectural University of Medicine ( Site 1525)

Kyoto, 602-8566, Japan

RECRUITING

Nagano Municipal Hospital ( Site 1526)

Nagano, 381-8551, Japan

RECRUITING

Nagasaki University Hospital ( Site 1523)

Nagasaki, 852-8501, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 1529)

Niigata, 951-8566, Japan

RECRUITING

Tokushima University Hospital ( Site 1513)

Tokushima, 770-8503, Japan

RECRUITING

Sarawak General Hospital ( Site 0526)

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Sunway Medical Centre ( Site 0529)

Petaling Jaya, Selangor, 47500, Malaysia

RECRUITING

Grupo Ollin Care ( Site 0544)

Pachuca, Hidalgo, 42000, Mexico

RECRUITING

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0541)

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Higiea Oncologia ( Site 0542)

Mexico City, Mexico City, 11810, Mexico

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0545)

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0540)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Centro de Investigacion Clinica de Oaxaca ( Site 0543)

Oaxaca City, Oaxaca, 68020, Mexico

RECRUITING

UMC St. Radboud ( Site 0601)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Maastricht UMC+ ( Site 0612)

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

VieCuri Medisch Centrum, locatie Venlo ( Site 0610)

Venlo, Limburg, 5912 BL, Netherlands

RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0602)

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Tergooiziekenhuizen, locatie Hilversum ( Site 0619)

Hilversum, North Holland, 1212 VG, Netherlands

RECRUITING

Spaarne Gasthuis - Hoofddorp ( Site 0608)

Hoofddorp, North Holland, 2134 TM, Netherlands

RECRUITING

Ziekenhuisgroep Twente, locatie Almelo ( Site 0615)

Hengelo, Overijssel, 7555 DL, Netherlands

RECRUITING

Erasmus Medisch Centrum ( Site 0611)

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 0600)

Schiedam, South Holland, 3118 JH, Netherlands

RECRUITING

Haga Ziekenhuis locatie Leyweg ( Site 0607)

The Hague, South Holland, 2545 AA, Netherlands

RECRUITING

Meander Medisch Centrum ( Site 0604)

Amersfoort, Utrecht, 3813 TZ, Netherlands

RECRUITING

Martini Ziekenhuis ( Site 0621)

Groningen, 9728 NT, Netherlands

RECRUITING

St. Antonius Ziekenhuis, locatie Utrecht ( Site 0620)

Utrecht, 3543 AZ, Netherlands

RECRUITING

Akershus Universitetssykehus-Onkologisk avdeling ( Site 0650)

Lorenskog, Akershus, 1474, Norway

RECRUITING

Sykehuset Innlandet HF Gjøvik ( Site 0652)

Gjøvik, Oppland, 2819, Norway

RECRUITING

St. Olavs Hospital-Kreftklinikken ( Site 0651)

Trondheim, Sor-Trondelag, 7030, Norway

RECRUITING

Oslo universitetssykehus, Radiumhospitalet ( Site 0653)

Oslo, 0379, Norway

RECRUITING

Unidad de Investigacion Oncologia Clínica Piura ( Site 0669)

Castilla, Piura, 20001, Peru

RECRUITING

Hospital Cayetano Heredia ( Site 0667)

Lima, 15012, Peru

RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0666)

Lima, 15036, Peru

RECRUITING

Instituto Nacional de Enfermedades Neoplásicas ( Site 0665)

Lima, 15038, Peru

RECRUITING

Instituto Neuro Cardiovascular de las Americas ( Site 0668)

Lima, 15047, Peru

RECRUITING

Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0688)

Poznan, Greater Poland Voivodeship, 61-731, Poland

RECRUITING

Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 0696)

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

RECRUITING

Pratia MCM Krakow ( Site 0692)

Krakow, Lesser Poland Voivodeship, 30-727, Poland

RECRUITING

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0686)

Siedlce, Masovian Voivodeship, 08-110, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie ( Site 0685)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Pratia Onkologia Katowice ( Site 0693)

Katowice, Silesian Voivodeship, 40-519, Poland

RECRUITING

National Cancer Centre Singapore ( Site 0760)

Singapore, Central Singapore, 168583, Singapore

RECRUITING

Tan Tock Seng Hospital ( Site 0761)

Singapore, Central Singapore, 308433, Singapore

RECRUITING

Cancercare Rondebosch Oncology ( Site 0771)

Cape Town, Gauteng, 7700, South Africa

RECRUITING

Wits Clinical Research ( Site 0776)

Johannesburg, Gauteng, 2193, South Africa

RECRUITING

Wilgers Oncology Centre ( Site 0775)

Pretoria, Gauteng, 0081, South Africa

RECRUITING

Curo Oncology Centre ( Site 0779)

Pretoria, Gauteng, 0084, South Africa

RECRUITING

LIFE GROENKLOOF ( Site 0777)

Pretoria, Gauteng, 0181, South Africa

RECRUITING

Chonnam National University Hwasun Hospital ( Site 0794)

Hwasun Gun, Jeonranamdo, 58128, South Korea

RECRUITING

The Catholic University of Korea St. Mary s Hospital ( Site 0795)

Seocho-gu, Seoul, 06591, South Korea

RECRUITING

Asan Medical Center ( Site 0791)

Songpagu, Seoul, 05505, South Korea

RECRUITING

Ulsan University Hospital ( Site 0793)

Donggu, Ulsan-Kwangyokshi, 44033, South Korea

RECRUITING

Severance Hospital Yonsei University Health System ( Site 0790)

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center ( Site 0792)

Seoul, 06351, South Korea

RECRUITING

Hospital Universitario Marqués de Valdecilla ( Site 0810)

Santander, Cantabria, 39008, Spain

RECRUITING

CHUS - Hospital Clinico Universitario ( Site 0815)

Santiago de Compostela, La Coruna, 15706, Spain

RECRUITING

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0811)

Majadahonda Madrid, Madrid, 28220, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón ( Site 0812)

Madrid, Madrid, Comunidad de, 28009, Spain

RECRUITING

Hospital del Mar ( Site 0822)

Barcelona, 08003, Spain

RECRUITING

Hospital Vall D Hebron ( Site 0814)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Reina Sofia ( Site 0816)

Córdoba, 14004, Spain

RECRUITING

Hospital Lucus Augusti ( Site 0813)

Lugo, 27003, Spain

RECRUITING

Hospital Universitario Quiron Madrid ( Site 0823)

Madrid, 28223, Spain

RECRUITING

Hospital Universitario Virgen de Valme ( Site 0819)

Seville, 41014, Spain

RECRUITING

Fundación Instituto Valenciano de Oncología ( Site 0821)

Valencia, 46009, Spain

RECRUITING

Skånes Universitetssjukhus Malmö ( Site 0841)

Malmo, Skåne County, 20502, Sweden

RECRUITING

Södersjukhuset ( Site 0844)

Stockholm, Stockholm County, 11883, Sweden

RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 0843)

Stockholm, Stockholm County, 171 64, Sweden

RECRUITING

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 0840)

Uppsala, Östergötland County, 751 85, Sweden

RECRUITING

Kantonspital Aarau ( Site 0857)

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

University Hospital Basel ( Site 0859)

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Hopitaux Universitaires de Geneve HUG. ( Site 0856)

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

HFR Fribourg - Hôpital Cantonal ( Site 0858)

Fribourg, 1708, Switzerland

RECRUITING

Stadtspital Triemli ( Site 0855)

Zurich, 8063, Switzerland

RECRUITING

National Taiwan University Hospital ( Site 0870)

Taiwan, Taipei, 10002, Taiwan

RECRUITING

Chang Gung Medical Foundation - Kaohsiung ( Site 0872)

Kaohsiung City, 83301, Taiwan

RECRUITING

Taichung Veterans General Hospital ( Site 0873)

Taichung, 40705, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 0875)

Taipei, 11217, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 0885)

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0887)

Dusit, Bangkok, 10300, Thailand

RECRUITING

Adana Medical Park Seyhan Hastanesi ( Site 0906)

Adana, 01140, Turkey (Türkiye)

RECRUITING

Hacettepe Universitesi Tip Fakultesi ( Site 0895)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Gazi University Health Research and Application Center Gazi Hospital ( Site 0903)

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa ( Site 0896)

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Konya Necmettin Erbakan Universitesi ( Site 0905)

Konya, 42080, Turkey (Türkiye)

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Prednisone; Prednisolone; prednisolone acetate; Serotonin 5-HT3 Receptor Antagonists; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

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: April 7, 2025
• First Posted: April 13, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): June 26, 2028
• Study Completion (Estimated): January 6, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

SG (2); DK (4); IE (3); US (47); BR (6); PE (5); ME (6); CH (5); CO (7); MY (2); CN (34); ES (11); TU (5); JP (31); PL (6); FR (9); AR (9); AU (3); KR (6); SE (4); ZA (5); HK (2); TW (4); IT (9); IL (6); DE (9); TH (2); NL (13); GU (3); GR (5); CL (2); NO (4); CZ (5)