A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Status: Recruiting
Location: See all (135) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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,
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
• Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
• Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment
Locations
United States
California
City of Hope Comprehensive Cancer Center ( Site 0049)
RECRUITING
Duarte
City of Hope Lennar Foundation Cancer Center ( Site 0059)
RECRUITING
Irvine
Moores Cancer Center ( Site 0010)
RECRUITING
La Jolla
Georgia
Emory University School of Medicine- Grady Campus ( Site 0103)
RECRUITING
Atlanta
Winship Cancer Institute, Emory University ( Site 0003)
RECRUITING
Atlanta
Michigan
Cancer and Hematology Centers of Western Michigan ( Site 0015)
RECRUITING
Grand Rapids
Minnesota
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032)
RECRUITING
Saint Louis Park
HealthPartners Cancer Center at Regions Hospital ( Site 0052)
RECRUITING
Saint Paul
Montana
St. Vincent Frontier Cancer Center-Research ( Site 0037)
RECRUITING
Billings
Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076)
RECRUITING
Grand Island
Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026)
RECRUITING
Omaha
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016)
RECRUITING
Hackensack
Texas
UT Southwestern Medical Center ( Site 0039)
RECRUITING
Dallas
Virginia
Blue Ridge Cancer Care ( Site 0024)
RECRUITING
Roanoke
Other Locations
Argentina
Centro Medico Dra De Salvo ( Site 0132)
RECRUITING
Caba
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0131)
RECRUITING
La Rioja
Instituto Alexander Fleming ( Site 0125)
RECRUITING
Mar Del Plata
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0129)
RECRUITING
Mar Del Plata
Centro Oncologico de Integracion Regional. COIR ( Site 0130)
RECRUITING
Mendoza
Sanatorio Parque ( Site 0126)
RECRUITING
Rosario
Centro de Diagnostico Investigación y Tratamiento Oncológico (CeDIT) ( Site 0135)
RECRUITING
Salta
Instituto San Marcos ( Site 0137)
RECRUITING
San Juan
Australia
Blacktown Hospital ( Site 0154)
RECRUITING
Blacktown
Gallipoli Medical Research Ltd ( Site 0153)
RECRUITING
Greenslopes
Peter MacCallum Cancer Centre ( Site 0152)
RECRUITING
Melbourne
Austria
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0170)
RECRUITING
Linz
Klinikum Wels-Grieskirchen GmbH ( Site 0171)
RECRUITING
Wels
Brazil
Hospital de Base de São José do Rio Preto ( Site 0176)
RECRUITING
São José Do Rio Preto
Chile
Bradfordhill ( Site 0200)
RECRUITING
Santiago
China
Peking University First Hospital ( Site 1434)
RECRUITING
Beijing
Shanghai General Hospital ( Site 1449)
RECRUITING
Beijing
The First Affiliated Hospital Of Fujian Medical University ( Site 1452)
RECRUITING
Fuzhou
Guangzhou First People's Hospital ( Site 1410)
RECRUITING
Guangzhou
Shandong Cancer Hospital ( Site 1421)
RECRUITING
Jinan
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 1425)
RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital ( Site 1414)
RECRUITING
Nanning
The First Affiliated Hospital of Ningbo University ( Site 1419)
RECRUITING
Ningbo
Fudan University Shanghai Cancer Center ( Site 1400)
RECRUITING
Shanghai
Shanghai Tenth People's Hospital ( Site 1441)
RECRUITING
Shanghai
Shanghai Tongji Hospital ( Site 1412)
RECRUITING
Shanghai
Zhongshan Hospital Fudan University ( Site 1430)
RECRUITING
Shanghai
The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 1469)
RECRUITING
Ürümqi
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1424)
RECRUITING
Wuhan
Henan Cancer Hospital ( Site 1472)
RECRUITING
Zhengzhou
Denmark
Aalborg Universitetshospital, Syd ( Site 0293)
RECRUITING
Aalborg
Vejle Sygehus ( Site 0291)
RECRUITING
Vejle
France
CHU Besançon ( Site 0305)
RECRUITING
Besançon
Centre François Baclesse ( Site 0311)
RECRUITING
Caen
Clinique Francois Chenieux ( Site 0312)
RECRUITING
Limoges
CHU de Rouen ( Site 0301)
RECRUITING
Rouen
Hôpital Foch ( Site 0309)
RECRUITING
Suresnes
Institut de Cancérologie de Lorraine Alexis Vautrin ( Site 0307)
RECRUITING
Vandœuvre-lès-nancy
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0352)
RECRUITING
Berlin
Urologicum Duisburg ( Site 0361)
RECRUITING
Duisburg
Universitaetsklinik Hamburg-Eppendorf ( Site 0351)
RECRUITING
Hamburg
Universitaetsklinikum Schleswig Holstein ( Site 0360)
RECRUITING
Lübeck
Studienpraxis Urologie ( Site 0358)
RECRUITING
Nürtingen
Greece
Henry Dunant Hospital ( Site 0385)
RECRUITING
Athens
Metropolitan General Hospital ( Site 0382)
RECRUITING
Athens
Guatemala
Med Clinic ( Site 0403)
RECRUITING
Guatemala City
MEDI-K ( Site 0401)
RECRUITING
Guatemala City
Onco Go ( Site 0402)
RECRUITING
Guatemala City
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 0415)
RECRUITING
Hong Kong
Tuen Mun Hospital ( Site 0416)
RECRUITING
New Territories
Israel
Rambam Health Care Campus ( Site 0462)
RECRUITING
Haifa
Meir Medical Center ( Site 0464)
RECRUITING
Kfar Saba
Rabin Medical Center ( Site 0461)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 0460)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 0463)
RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center. ( Site 0466)
RECRUITING
Ẕerifin
Italy
Azienda USL 8 di Arezzo ( Site 0503)
RECRUITING
Arezzo
Humanitas Gavazzeni ( Site 0508)
RECRUITING
Bergamo
Istituto Nazionale Tumori Regina Elena ( Site 0507)
RECRUITING
Rome
Istituto Clinico Humanitas ( Site 0504)
RECRUITING
Rozzano
Centro Ricerche Cliniche di Verona ( Site 0506)
RECRUITING
Verona
Japan
University of Yamanashi Hospital ( Site 1506)
RECRUITING
Chūō
Harasanshin Hospital ( Site 1517)
RECRUITING
Fukuoka
Kyushu University Hospital ( Site 1515)
RECRUITING
Fukuoka
Gifu University Hospital ( Site 1527)
RECRUITING
Gifu
University of the Ryukyus Hospital ( Site 1519)
RECRUITING
Ginowan
Hiroshima University Hospital ( Site 1512)
RECRUITING
Hiroshima
Kanazawa Medical University Hospital ( Site 1507)
RECRUITING
Kahoku-gun
Shonan Kamakura General Hospital ( Site 1530)
RECRUITING
Kamakura
Hospital of the University of Occupational and Environmental Health, Japan ( Site 1510)
RECRUITING
Kitakyushu
Kobe University Hospital ( Site 1511)
RECRUITING
Kobe
Dokkyo Medical University Saitama Medical Center ( Site 1502)
RECRUITING
Koshigaya
National Hospital Organization Kumamoto Medical Center ( Site 1524)
RECRUITING
Kumamoto
Kurume University Hospital ( Site 1516)
RECRUITING
Kurume
Nagano Municipal Hospital ( Site 1526)
RECRUITING
Nagano
Nagoya University Hospital ( Site 1508)
RECRUITING
Nagoya
Bell Land General Hospital ( Site 1509)
RECRUITING
Sakai
Toho University Sakura Medical Center ( Site 1503)
RECRUITING
Sakura
Hokkaido University Hospital ( Site 1500)
RECRUITING
Sapporo
Tokushima University Hospital ( Site 1513)
RECRUITING
Tokushima
Yamaguchi University Hospital ( Site 1522)
RECRUITING
Ube
Oita University Hospital ( Site 1521)
RECRUITING
Yufu
Netherlands
Meander Medisch Centrum ( Site 0604)
RECRUITING
Amersfoort
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0602)
RECRUITING
Amsterdam
Ziekenhuisgroep Twente, locatie Almelo ( Site 0615)
RECRUITING
Hengelo
Tergooiziekenhuizen, locatie Hilversum ( Site 0619)
RECRUITING
Hilversum
Spaarne Gasthuis - Hoofddorp ( Site 0608)
RECRUITING
Hoofddorp
Sint Antonius Ziekenhuis, locatie Nieuwegein ( Site 0620)
RECRUITING
Nieuwegein
UMC St. Radboud ( Site 0601)
RECRUITING
Nijmegen
Haga Ziekenhuis locatie Leyweg ( Site 0607)
RECRUITING
The Hague
VieCuri Medisch Centrum, locatie Venlo ( Site 0610)
RECRUITING
Venlo
Norway
Sykehuset Innlandet HF Gjøvik ( Site 0652)
RECRUITING
Gjøvik
Akershus Universitetssykehus-Onkologisk avdeling ( Site 0650)
RECRUITING
Lorenskog
Oslo universitetssykehus, Radiumhospitalet ( Site 0653)
RECRUITING
Oslo
St. Olavs Hospital-Kreftklinikken ( Site 0651)
RECRUITING
Trondheim
Poland
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 0696)
RECRUITING
Bydgoszcz
Pratia Onkologia Katowice ( Site 0693)
RECRUITING
Katowice
Pratia MCM Krakow ( Site 0692)
RECRUITING
Krakow
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0688)
RECRUITING
Poznan
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0686)
RECRUITING
Siedlce
Republic of Korea
Ulsan University Hospital ( Site 0793)
RECRUITING
Donggu
Chonnam National University Hwasun Hospital ( Site 0794)
RECRUITING
Hwasun Gun
The Catholic University of Korea St. Mary s Hospital ( Site 0795)
RECRUITING
Seocho-gu
Samsung Medical Center ( Site 0792)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 0790)
RECRUITING
Seoul
Asan Medical Center ( Site 0791)
RECRUITING
Songpagu
South Africa
Cancercare Rondebosch Oncology ( Site 0771)
RECRUITING
Cape Town
Spain
Hospital del Mar ( Site 0822)
RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañón ( Site 0812)
RECRUITING
Madrid
Hospital Universitario Quiron Madrid ( Site 0823)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0811)
RECRUITING
Majadahonda Madrid
CHUS - Hospital Clinico Universitario ( Site 0815)
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen de Valme ( Site 0819)
RECRUITING
Seville
Sweden
Karolinska Universitetssjukhuset Solna ( Site 0843)
RECRUITING
Stockholm
Switzerland
Kantonspital Aarau ( Site 0857)
RECRUITING
Aarau
Hopitaux Universitaires de Geneve HUG. ( Site 0856)
RECRUITING
Geneva
Stadtspital Triemli ( Site 0855)
RECRUITING
Zurich
Taiwan
Chang Gung Medical Foundation - Kaohsiung ( Site 0872)
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital ( Site 0873)
RECRUITING
Taichung
Taipei Veterans General Hospital ( Site 0875)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 0870)
RECRUITING
Taiwan
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-05-13
Estimated Completion Date: 2031-01-06
Participants
Target number of participants: 1440
Treatments
Experimental: I-DXd
Participants receive I-DXd 12mg/kg every 3 weeks (q3w)
Active_comparator: Docetaxel
Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label
Related Therapeutic Areas
Sponsors
Collaborators: Daiichi Sankyo
Leads: Merck Sharp & Dohme LLC