A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
KLK2-PASenger
A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
2 other identifiers
interventional
800
15 countries
97
Brief Summary
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) 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Typical duration for phase_3
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2025
CompletedFirst Posted
Study publicly available on registry
November 10, 2025
CompletedStudy Start
First participant enrolled
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 20, 2029
April 14, 2026
April 1, 2026
1.9 years
November 6, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Radiographic Progression-Free Survival (rPFS) Assessed by BICR
rPFS 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.
Up to approximately 1 years 10 months
Secondary Outcomes (20)
Overall Survival (OS)
Up to approximately 4 years 5 months
Time to Symptomatic Progression (TSP)
Up to approximately 4 years 5 months
Time to Subsequent Therapy (TST)
Up to approximately 4 years 5 months
Time to Skeletal-Related Event (TSRE)
Up to approximately 4 years 5 months
Objective Response Rate (ORR)
Up to approximately 4 years 5 months
- +15 more secondary outcomes
Study Arms (2)
Pasritamig+Docetaxel
EXPERIMENTALParticipants will receive pasritamig along with docetaxel until the end of trial (EOT) visit or until confirmed radiographic progression by blinded independent central review (BICR), or any other protocol defined criteria are met.
Docetaxel
ACTIVE COMPARATORParticipants will receive docetaxel along with prednisone as background medication.
Interventions
Eligibility Criteria
You may qualify if:
- Have histologically confirmed adenocarcinoma of the prostate
- Have disease that is metastatic at the time of the screening 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 milliliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening
- Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) but received 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
You may not qualify if:
- 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) because the natural history or treatment could interfere with study endpoints
- Received cytotoxic chemotherapy for prostate cancer in any setting
- Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
Arizona Clinical Trials
Chandler, Arizona, 85225, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
University Of California San Diego
La Jolla, California, 92037, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Kaiser Permanente Southern California
Riverside, California, 92505, United States
Providence Saint John s Health Center
Santa Monica, California, 90404, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
Colorado Clinical Research
Lakewood, Colorado, 80228, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Duly Health and Care
Lisle, Illinois, 60532, United States
Cancer Center of Kansas Heritage Plaza Medical Building
Wichita, Kansas, 67214, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
Profound Research LLC at Cancer and Leukemia Center
Sterling Heights, Michigan, 48314, United States
HealthPartners Frauenshuh Cancer Center CRC West
Saint Louis Park, Minnesota, 55426, United States
HealthPartners Cancer Center at Regions Hospital CRC East
Saint Paul, Minnesota, 55101, United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, 68506, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Avera Medical Group
Sioux Falls, South Dakota, 57105, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Houston Metro Urology
Houston, Texas, 77027, United States
Texas Oncology 1
Sugar Land, Texas, 77479, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Fred Hutch Cancer Center Sloan Clinic 2
Seattle, Washington, 98109, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Sydney Adventist Hospital
Wahroonga, 2076, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
ZAS Augustinus
Antwerp, 2610, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, 7100, Belgium
CHC MontLegia
Liège, 4000, Belgium
NAIC Nair Antunes Instituto do Cancer
Bauru, 17033-495, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Hospital Ana Nery Santa Cruz do Sul
Santa Cruz do Sul, 96835-100, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060 870, Brazil
ESHO Empresa De Servicos Hospitalares S A
São Paulo, 01232 010, Brazil
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4, Canada
Centre de Recherche du CHUM
Montreal, Quebec, H2X 0A9, Canada
CHU de Quebec Universite Laval
Québec, Quebec, G1R 2J6, Canada
Beijing Luhe Hospital, Capital Medical University
Beijing, 101100, China
The Third People's Hospital of Chengdu
Chengdu, 610014, China
West China Hospital Sichuan University
Chengdu, 610041, China
Sun Yat Sen University Cancer Center
Guangzhou, 510060, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Nanjing Drum Tower Hospital
Nanjing, 210009, China
The Second Hospital Of Tianjin Medical University
Tianjin, 300211, China
The Central Hospital of Wuhan
Wuhan, 430014, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Centre Oscar Lambret
Lille, 59000, France
Groupe Hospitalo-Universitaire Carémeau
Nîmes, 30900, France
Hopital Europeen Georges-Pompidou
Paris, 75908, France
Gustave Roussy
Villejuif, 94800, France
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
Kitasato University Hospital
Sagamihara, 252-0375, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Hospital Wanita dan Kanak-Kanak Sabah
Kota Kinabalu, 88996, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
Pan American Center for Oncology Trials LLC
San Juan, 935, Puerto Rico
National Cancer Center
Goyang-si, 10408, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia, 30008, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Gral. Univ. Valencia
Valencia, 46014, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, 50009, Spain
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hospital
Taichung, 407219, Taiwan
Tungs' Taichung MetroHarbor Hospital
Taichung, 435, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Istanbul University Cerrahpasa tip Fakultesi
Istanbul, 34096, Turkey (Türkiye)
Koc Universitesi Hastanesi
Istanbul, 34147, Turkey (Türkiye)
Medicana International Izmir
Izmir, 35170, Turkey (Türkiye)
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Beatson West Of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
St Bartholomews Hospital
London, EC1A 7BE, United Kingdom
The Royal Marsden NHS Trust
London, SW3 6JJ, United Kingdom
The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
Newcastle upon Tyne, NE7 7DN, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
Preston, PR2 9HT, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
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 6, 2025
First Posted
November 10, 2025
Study Start
December 19, 2025
Primary Completion (Estimated)
November 19, 2027
Study Completion (Estimated)
July 20, 2029
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.