A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (KLK2-PASenger)
August 27, 2026 updated by: Janssen Research & Development, LLC
A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to find out whether treatment with pasritamig and docetaxel prolongs radiographic progression free survival (rPFS) (the length of time from start of treatment until disease worsens as determined by scans or death due to any cause) when compared to treatment with docetaxel in participants with metastatic castrate-resistant prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the bladder, that grows despite low levels of male hormones).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
800
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study1@its.jnj.com
Study Locations
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Heidelberg, Australia, 3084
- Recruiting
- Warringal Private Hospital
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Kurralta Park, Australia, 5037
- Recruiting
- Icon Cancer Centre Kurralta Park
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Melbourne, Australia, 3000
- Recruiting
- Peter MacCallum Cancer Centre
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Wahroonga, Australia, 2076
- Recruiting
- Sydney Adventist Hospital
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Woolloongabba, Australia, 4102
- Recruiting
- Princess Alexandra Hospital
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Aalst, Belgium, 9300
- Recruiting
- AZORG campus Aalst Moorselbaan
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Antwerp, Belgium, 2610
- Recruiting
- ZAS Augustinus
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Ghent, Belgium, 9000
- Recruiting
- AZ Maria Middelares
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La Louvière, Belgium, 7100
- Recruiting
- Chu Helora Hospital La Louviere Site Jolimont
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Liège, Belgium, 4000
- Recruiting
- CHC MontLegia
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Bauru, Brazil, 17033-495
- Recruiting
- NAIC Nair Antunes Instituto do Cancer
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Natal, Brazil, 59062 000
- Recruiting
- Liga Norte Riograndense Contra O Cancer
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Santa Cruz do Sul, Brazil, 96835-100
- Recruiting
- Hospital Ana Nery Santa Cruz do Sul
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Santo André, Brazil, 09060 870
- Recruiting
- CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
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São Paulo, Brazil, 01243 020
- Recruiting
- Hospital Samaritano de Sao Paulo
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British Columbia
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Vancouver, British Columbia, Canada, V5Z4E6
- Recruiting
- British Columbia Cancer Agency
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Victoria, British Columbia, Canada, V8R 6V5
- Recruiting
- British Columbia Cancer Agency Vancouver Island Centre
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- The Ottawa Hospital Cancer Centre
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Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H2X 0A9
- Recruiting
- Centre de recherche du CHUM
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Québec, Quebec, Canada, G1R 2J6
- Recruiting
- CHU de Quebec Universite Laval
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Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
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Beijing, China, 101100
- Recruiting
- Beijing Luhe Hospital, Capital Medical University
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Chengdu, China, 610041
- Recruiting
- West China Hospital Sichuan University
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Chengdu, China, 610014
- Recruiting
- The Third People's Hospital of Chengdu
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Chongqing, China, 400030
- Recruiting
- Chongqing University Cancer Hospital
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Guangzhou, China, 510120
- Recruiting
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, China, 510060
- Recruiting
- Sun Yat Sen University Cancer Center
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Hangzhou, China, 310009
- Recruiting
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Nanjing, China, 210009
- Recruiting
- Nanjing Drum Tower Hospital
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Shanghai, China, 200080
- Recruiting
- Shanghai General Hospital
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Shanghai, China, 200031
- Recruiting
- Huashan Hospital Fudan University
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Shanghai, China, 200082
- Recruiting
- Xinhua hospital,Shanghai Jiaotong University
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Tianjin, China, 300211
- Recruiting
- The Second Hospital of Tianjin Medical University
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Wuhan, China, 430014
- Recruiting
- The Central Hospital of Wuhan
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Xi'an, China, 710061
- Recruiting
- The First Affiliated Hospital of Xian Jiaotong University
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Bordeaux, France, 33076
- Recruiting
- Institut Bergonie
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Clermont-Ferrand, France, 63011
- Recruiting
- Centre Jean Perrin
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Lille, France, 59000
- Recruiting
- Centre Oscar Lambret
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Lyon, France, 69008
- Recruiting
- Centre Léon Bérard
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Nîmes, France, 30900
- Recruiting
- Groupe Hospitalo-Universitaire Carémeau
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Paris, France, 75908
- Recruiting
- Hopital Europeen Georges-Pompidou
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Rennes, France, 35062
- Recruiting
- Centre Eugène Marquis
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Villejuif, France, 94800
- Recruiting
- Gustave Roussy
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Dresden, Germany, 01307
- Recruiting
- Universitätsklinikum Carl Gustav Carus Dresden
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Duisburg, Germany, 47169
- Recruiting
- Urologicum Duisburg
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Essen, Germany, 45147
- Recruiting
- Universitaetsklinikum Essen
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Hamburg, Germany, 20246
- Recruiting
- Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
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München, Germany, 81675
- Recruiting
- Klinikum rechts der Isar an der Technischen Universitat Munchen
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Nürtingen, Germany, 72622
- Recruiting
- Studienpraxis Urologie Drs. Feyerabend
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Florence, Italy, 50134
- Recruiting
- Azienda Ospedaliero Universitaria Careggi
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Localita La Schiana Pozzuoli, Italy, 80078
- Recruiting
- ASL Napoli 2 Nord-SM delle Grazie Hospital
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Milan, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele
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Milan, Italy, 20141
- Recruiting
- Istituto Europeo Di Oncologia
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Roma, Italy, 00144
- Recruiting
- Istituto Nazionale Tumori Regina Elena
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Torino, Italy, 10126
- Recruiting
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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Bunkyō City, Japan, 113 8431
- Recruiting
- Juntendo University Hospital
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Hirakata, Japan, 573-1191
- Recruiting
- Kansai Medical University Hospital
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Kanazawa, Japan, 920 8641
- Recruiting
- Kanazawa University Hospital
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Kobe, Japan, 650 0017
- Recruiting
- Kobe University Hospital
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Sagamihara, Japan, 252-0375
- Recruiting
- Kitasato University Hospital
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Sunto Gun, Japan, 411 8777
- Recruiting
- Shizuoka Cancer Center
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Yokohama, Japan, 232 0024
- Recruiting
- Yokohama City University Medical Center
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Kota Kinabalu, Malaysia, 88996
- Recruiting
- Hospital Wanita dan Kanak-Kanak Sabah
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Kuala Lumpur, Malaysia, 59100
- Recruiting
- University Malaya Medical Centre
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Kuala Lumpur, Malaysia, 50586
- Recruiting
- Hospital Kuala Lumpur
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Kuala Lumpur, Malaysia, 59100
- Recruiting
- Pantai Hospital Kuala Lumpur
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Kuching, Malaysia, 93586
- Recruiting
- Hospital Umum Sarawak
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San Juan, Puerto Rico, 935
- Recruiting
- Pan American Center for Oncology Trials LLC
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Goyang-si, South Korea, 10408
- Recruiting
- National Cancer Center
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Seoul, South Korea, 05505
- Recruiting
- Asan Medical Center
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Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
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Seoul, South Korea, 03722
- Recruiting
- Severance Hospital Yonsei University Health System
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Seoul, South Korea, 06591
- Recruiting
- The Catholic University of Korea Seoul St Marys Hospital
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Badalona, Spain, 08916
- Recruiting
- Hosp. Univ. Germans Trias I Pujol
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Madrid, Spain, 28034
- Recruiting
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spain, 28041
- Recruiting
- Hosp. Univ. 12 de Octubre
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Murcia, Spain, 30008
- Recruiting
- Hosp. Gral. Univ. J.M. Morales Meseguer
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Seville, Spain, 41009
- Recruiting
- Hosp. Virgen Macarena
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Valencia, Spain, 46014
- Recruiting
- Hosp. Gral. Univ. Valencia
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Zaragoza, Spain, 50009
- Recruiting
- Hosp. Clinico Univ. Lozano Blesa
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Taichung, Taiwan, 435
- Recruiting
- Tungs' Taichung MetroHarbor Hospital
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Taichung, Taiwan, 404
- Recruiting
- China Medical University Hospital
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Taichung, Taiwan, 407219
- Recruiting
- Taichung Veterans General Hospital
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Tainan, Taiwan, 704
- Recruiting
- National Cheng Kung University Hospital
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Taoyuan, Taiwan, 333
- Recruiting
- Linkou Chang Gung Memorial Hospital
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Adana, Turkey (Türkiye), 01170
- Recruiting
- Adana City Hospital
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Ankara, Turkey (Türkiye), 06010
- Recruiting
- Gulhane Training and Research Hospital
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Ankara, Turkey (Türkiye), 06100
- Recruiting
- Ankara University Medical Faculty
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Istanbul, Turkey (Türkiye), 34096
- Recruiting
- Istanbul University Cerrahpasa tip Fakultesi
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Istanbul, Turkey (Türkiye), 34147
- Recruiting
- Koc Universitesi Hastanesi
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Izmir, Turkey (Türkiye), 35170
- Recruiting
- Medicana International Izmir
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Cardiff, United Kingdom, CF14 2TL
- Recruiting
- Velindre Cancer Centre
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Glasgow, United Kingdom, G12 0YN
- Recruiting
- Beatson West of Scotland Cancer Centre
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London, United Kingdom, EC1A 7BE
- Recruiting
- St Bartholomews Hospital
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London, United Kingdom, SW3 6JJ
- Recruiting
- The Royal Marsden NHS Trust
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Newcastle upon Tyne, United Kingdom, NE7 7DN
- Recruiting
- The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
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Preston, United Kingdom, PR2 9HT
- Recruiting
- Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
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Sutton, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden Hospital
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Arizona
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Chandler, Arizona, United States, 85225
- Recruiting
- Arizona Clinical Trials
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Recruiting
- Arkansas Urology
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California
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Fountain Valley, California, United States, 92708
- Recruiting
- MemorialCare Orange Coast Medical Center
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La Jolla, California, United States, 92037
- Recruiting
- University Of California San Diego
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Los Alamitos, California, United States, 90720
- Recruiting
- Cancer and Blood Specialty Clinic
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Los Angeles, California, United States, 90033
- Recruiting
- USC Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90067
- Recruiting
- Valkyrie Clinical Trials
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Riverside, California, United States, 92505
- Recruiting
- Kaiser Permanente Southern California
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San Diego, California, United States, 92123
- Recruiting
- Sharp Center for Research
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Santa Monica, California, United States, 90404
- Recruiting
- Providence Saint John s Health Center
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Colorado
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Aurora, Colorado, United States, 80012
- Recruiting
- Rocky Mountain Cancer Centers
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Edwards, Colorado, United States, 81632
- Recruiting
- Vail Health Shaw Cancer Center
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Grand Junction, Colorado, United States, 81505
- Recruiting
- Grand Valley Oncology
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Lakewood, Colorado, United States, 80228
- Recruiting
- Colorado Clinical Research
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Florida
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Orlando, Florida, United States, 32803
- Recruiting
- AdventHealth Orlando
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Sarasota, Florida, United States, 34232
- Recruiting
- Florida Cancer Specialists
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Georgia
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Atlanta, Georgia, United States, 30322
- Recruiting
- Winship Cancer Institute Emory University
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Illinois
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Lisle, Illinois, United States, 60532
- Recruiting
- Duly Health and Care
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Kansas
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Wichita, Kansas, United States, 67214
- Recruiting
- Cancer Center of Kansas Heritage Plaza Medical Building
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Kentucky
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Edgewood, Kentucky, United States, 41017
- Recruiting
- St Elizabeth Healthcare
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Louisville, Kentucky, United States, 40207
- Recruiting
- Norton Cancer Institute
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Louisiana
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Metairie, Louisiana, United States, 70006
- Recruiting
- East Jefferson General Hospital
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Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins Hospital
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins Medical Institutions
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Towson, Maryland, United States, 21204
- Recruiting
- Chesapeake Urology Research Associates
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Michigan
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Sterling Heights, Michigan, United States, 48314
- Recruiting
- Profound Research LLC at Cancer and Leukemia Center
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Minnesota
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Saint Louis Park, Minnesota, United States, 55426
- Recruiting
- HealthPartners Frauenshuh Cancer Center CRC West
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Saint Paul, Minnesota, United States, 55101
- Recruiting
- HealthPartners Cancer Center at Regions Hospital CRC East
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Mississippi
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Jackson, Mississippi, United States, 39216
- Recruiting
- University of Mississippi Medical Center
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Missouri
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St Louis, Missouri, United States, 63110
- Recruiting
- Washington University
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Recruiting
- NHO Revive Research Institute, LLC
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New Jersey
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East Brunswick, New Jersey, United States, 08816
- Recruiting
- Astera Cancer Care
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New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Cancer Institute of New Jersey
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New York
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Mineola, New York, United States, 11501
- Recruiting
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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New York, New York, United States, 10016
- Recruiting
- NYU Langone Health Laura and Isaac Perlmutter Cancer Center
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The Bronx, New York, United States, 10461
- Recruiting
- Montefiore Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- Recruiting
- University of Cincinnati
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Oregon
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Springfield, Oregon, United States, 97477
- Recruiting
- Oregon Urology Institute
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Recruiting
- Lehigh Valley Hospital
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Bala-Cynwyd, Pennsylvania, United States, 19004
- Recruiting
- MidLantic Urology
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Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Milton S. Hershey Medical Center
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Recruiting
- Carolina Urologic Research Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Recruiting
- Avera Medical Group
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Tennessee
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Knoxville, Tennessee, United States, 37909
- Recruiting
- Tennessee Cancer Specialists
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Texas
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Austin, Texas, United States, 78731
- Recruiting
- Texas Oncology
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Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Medical Center
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Houston, Texas, United States, 77027
- Recruiting
- Houston Metro Urology
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Sugar Land, Texas, United States, 77479
- Recruiting
- Texas Oncology 1
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Virginia
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Fairfax, Virginia, United States, 22031
- Recruiting
- Virginia Cancer Specialists
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Washington
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Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutchinson Cancer Research Center
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Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutch Cancer Center Sloan Clinic 2
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- Have histologically confirmed adenocarcinoma of the prostate
- Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m^Tc bone scan as determined by the investigator
- Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) at screening
- Have progressed by PSA or CT/MRI or 99m^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Exclusion criteria:
- Known history of either brain or leptomeningeal prostate cancer metastases
- Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
- Prior or concurrent second malignancy (other than the disease under study)
- Received cytotoxic chemotherapy for prostate cancer in any setting
- Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pasritamig+Docetaxel
Participants will receive pasritamig along with docetaxel until the end of treatment (EOT) visit or until radiographic disease progression is confirmed by blinded independent central review (BICR), or any other protocol defined criteria are met.
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Docetaxel will be administered.
Pasritamig will be administered.
Other Names:
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Active Comparator: Docetaxel
Participants will receive docetaxel along with prednisone/prednisolone as background medication.
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Docetaxel will be administered.
Prednisone/Prednisolone will be administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 1 years 10 months
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rPFS by CT/MRI or bone scan is assessed by BICR and is defined as the time from the date of randomization to the first date of radiographic disease progression, or death due to any cause, whichever occurs first.
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Up to approximately 1 years 10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall Survival (OS)
Time Frame: Up to approximately 4 years 5 months
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Up to approximately 4 years 5 months
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Objective Response Rate (ORR)
Time Frame: Up to approximately 4 years 5 months
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ORR is defined as the proportion of participants who have measurable disease at baseline and have complete response (CR) or partial response (PR) or better by objective radiographic disease evaluation per response evaluation criteria in solid tumors (RECIST) version.1.1 response criteria and no bone progression as per prostate cancer working group 3 (PCWG3) as determined by the BICR.
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Up to approximately 4 years 5 months
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Duration of Response (DOR)
Time Frame: Up to approximately 4 years 5 months
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DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.
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Up to approximately 4 years 5 months
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Duration of PSA Response
Time Frame: Baseline and up to approximately 4 years 5 months
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Duration of a PSA response is the time taken to achieve a PSA response that is decrease in PSA from baseline by >= 50%.
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Baseline and up to approximately 4 years 5 months
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Progression Free Survival After Subsequent Therapy (PFS2)
Time Frame: Up to approximately 4 years 5 months
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PFS2 is defined as the time from randomization to the date of progression (radiographic, clinical, or PSA progression) on the first subsequent anti-cancer (second progression), or death from any cause, whichever comes first.
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Up to approximately 4 years 5 months
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Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Time Frame: Up to approximately 4 years 5 months
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the treatment.
An SAE: results in death, is life-threatening, requires inpatient hospitalization or prolonging hospitalization, results in disability, is a congenital birth defect, is a suspected transmission of any infectious agent via a medicinal product, is indicating suicidal ideation, is medically important.
Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
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Up to approximately 4 years 5 months
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Number of Participants With Clinical Laboratory Abnormalities
Time Frame: Up to approximately 4 years 5 months
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Participants with laboratory abnormalities (hematology, serum chemistry, coagulation, and tumor markers) will be reported.
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Up to approximately 4 years 5 months
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Change from Baseline in Health Related Quality of Life (HRQoL) as Assessed by Brief Pain Inventory-Short Form (BPI-SF)
Time Frame: Baseline up to approximately 4 years 5 months
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The BPI-SF was developed to measure both intensity or severity of pain and pain interference with daily life dimensions.
It measures pain intensity via 4 questions, that is, "pain at its worst in the last 24 hours", "pain at its least in the last 24 hours", "pain on the average", and "pain you have right now".
The BPI-SF assesses how much pain has interfered with the following 7 activities: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Higher score indicates more pain.
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Baseline up to approximately 4 years 5 months
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Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cancer Module (EORTC QLQ-C30) Scale Score
Time Frame: Baseline up to approximately 4 years 5 months
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The EORTC QLQ-C30 - Version 3 is a self-administered, 30-item questionnaire measuring the health-related quality of life of participants with cancer.
EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much".
Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent".
A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.
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Baseline up to approximately 4 years 5 months
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Change from Baseline in HRQoL as Assessed by EORTC Quality of Life Questionnaire-Prostate (EORTC QLQ-PR25) Scale Score
Time Frame: Baseline up to approximately 4 years 5 months
|
The EORTC QLQ-PR25 is a self-completed instrument was specifically designed for prostate cancer patients and includes 25 items that cover 6 dimensions: (1) PR URI (urinary symptoms, 8 items), (2) PR BOW (bowel symptoms, 4 items), (3) PR HTR (hormonal treatment-related symptoms, 6 items), (4) PR AID (incontinence aid, 1 item), (5) PR SAC (sexually active, 2 items); and (6) PR SFU (sexual function, 4 items).
Higher scores on symptom domains (for example., urinary, bowel, etc.) indicate greater symptom burden and higher scores on function domains (for example, Sexual Function) indicate better functioning.
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Baseline up to approximately 4 years 5 months
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Change from Baseline in HRQoL as Assessed by European Quality of Life Visual Analog Scale (EQ-5D VAS) Score
Time Frame: Baseline up to approximately 4 years 5 months
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The EQ-5D descriptive system comprises 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The EQ-5D includes a visual analog scale (EQ-VAS) that has endpoints labeled "best imaginable health state" and "worst imaginable health state" anchored at 100 and 0, respectively.
Here, higher score indicates better quality of life.
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Baseline up to approximately 4 years 5 months
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Time to Sustained Worsening of Pain as Assessed by BPI-SF
Time Frame: Up to approximately 4 years 5 months
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Time to sustained worsening of pain will be reported using BPI-SF.
The BPI-SF was developed to measure both intensity or severity of pain and pain interference with daily life dimensions.
It measures pain intensity via 4 questions, that is, "pain at its worst in the last 24 hours", "pain at its least in the last 24 hours", "pain on the average", and "pain you have right now".
The BPI-SF assesses how much pain has interfered with the following 7 activities: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Higher score indicates more pain.
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Up to approximately 4 years 5 months
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European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Scale Score
Time Frame: Up to approximately 4 years 5 months
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The EQ-5D descriptive system comprises 5 items across the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The EQ-5D-5L uses a 5-point Likert response scale ranging from "No problems" to "Extreme problems".
Here, higher score indicates better quality of life.
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Up to approximately 4 years 5 months
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Treatment Side Effect as Assessed by EORTC IL46 Score
Time Frame: Up to approximately 4 years 5 months
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The EORTC IL46 is a single question that assesses bother (burden) of treatment.
It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
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Up to approximately 4 years 5 months
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Time to Symptomatic Progression (TSP)
Time Frame: Up to approximately 4 years 5 months
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TSP is defined as the time from the date of randomization to the date of the first occurrence of any of the following: the use of external beam radiation to relieve cancer-related symptoms, the need for tumor-related surgical intervention, other cancer-related procedures, cancer-related morbid events, and initiation of a new systemic anticancer therapy because of cancer symptoms.
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Up to approximately 4 years 5 months
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Time to Subsequent Therapy (TST)
Time Frame: Up to approximately 4 years 5 months
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TST is defined as time from randomization to the initiation of any subsequent systemic anticancer therapy for prostate cancer
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Up to approximately 4 years 5 months
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Time to Skeletal-Related Event (TSRE)
Time Frame: Up to approximately 4 years 5 months
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TSRE is defined as the time from the date of randomization to the date of first occurrence of any of the following (whichever occurs first): the use of external beam radiation therapy to relieve skeletal symptoms, the need for tumor-related orthopedic surgical intervention, the occurrence of new bone fractures (cancer-related; vertebral or non-vertebral) or the occurrence of tumor-related spinal cord compression.
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Up to approximately 4 years 5 months
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Time to Prostate-Specific Antigen (PSA) Progression
Time Frame: Up to approximately 4 years 5 months
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Time to PSA progression is defined as the time from randomization to the first date of documented PSA progression per prostate cancer working group 3 (PCWG3) criteria.
PSA progression is defined as: (1) After a decline from baseline, PSA increases greater than or equal to (>=) 25% and >=2 nanogram per milliliter (ng/mL) above the nadir, confirmed by a second value >=3 weeks later (that is, a confirmed rising trend), or (2) If there is no decline from baseline, PSA increases >=25% and >=2 ng/mL from baseline after 12 weeks
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Up to approximately 4 years 5 months
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Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 50 Response
Time Frame: Up to approximately 4 years 5 months
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PSA-50 response is defined as the proportion of participants with a reduction in blood concentration of PSA (ng/mL) to 50% from baseline, confirmed by a second value, at least 3 weeks apart.
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Up to approximately 4 years 5 months
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Proportion of Participants Who Achieved Prostate-Specific Antigen (PSA) 90 Response
Time Frame: Up to approximately 4 years 5 months
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PSA-90 response is defined as the proportion of participants with a reduction in blood concentration of PSA (ng/mL) to 90% from baseline, confirmed by a second value, at least 3 weeks apart.
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Up to approximately 4 years 5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2025
Primary Completion (Estimated)
November 19, 2027
Study Completion (Estimated)
July 20, 2029
Study Registration Dates
First Submitted
November 6, 2025
First Submitted That Met QC Criteria
November 6, 2025
First Posted (Actual)
November 10, 2025
Study Record Updates
Last Update Posted (Actual)
August 28, 2026
Last Update Submitted That Met QC Criteria
August 27, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Prostatic Neoplasms, Castration-Resistant
- Organic Chemicals
- Hydrocarbons
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Polycyclic Compounds
- Taxoids
- Cyclodecanes
- Diterpenes
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Pregnadienetriols
- Pregnadienediols
- Docetaxel
- Prednisone
- Prednisolone
Other Study ID Numbers
- 78278343PCR3003 (Janssen Research & Development, LLC)
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-522713-29-00 (Registry Identifier: EUCT number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.