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
Status: Recruiting
Location: See all (97) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Urology
RECRUITING
Little Rock
Arizona
Arizona Clinical Trials
RECRUITING
Chandler
California
University Of California San Diego
RECRUITING
La Jolla
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Kaiser Permanente Southern California
RECRUITING
Riverside
Providence Saint John s Health Center
RECRUITING
Santa Monica
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Aurora
Grand Valley Oncology
RECRUITING
Grand Junction
Colorado Clinical Research
RECRUITING
Lakewood
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Illinois
Duly Health and Care
RECRUITING
Lisle
Kansas
Cancer Center of Kansas Heritage Plaza Medical Building
RECRUITING
Wichita
Louisiana
East Jefferson General Hospital
RECRUITING
Metairie
Michigan
Profound Research LLC at Cancer and Leukemia Center
RECRUITING
Sterling Heights
Minnesota
HealthPartners Frauenshuh Cancer Center CRC West
RECRUITING
Saint Louis Park
HealthPartners Cancer Center at Regions Hospital CRC East
RECRUITING
Saint Paul
Nebraska
NHO Revive Research Institute, LLC
RECRUITING
Lincoln
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Oregon
Oregon Urology Institute
RECRUITING
Springfield
Pennsylvania
Lehigh Valley Hospital
RECRUITING
Allentown
MidLantic Urology
RECRUITING
Bala-cynwyd
Penn State Milton S. Hershey Medical Center
RECRUITING
Hershey
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
South Dakota
Avera Medical Group
RECRUITING
Sioux Falls
Tennessee
Tennessee Cancer Specialists
RECRUITING
Knoxville
Texas
Houston Metro Urology
RECRUITING
Houston
Texas Oncology 1
RECRUITING
Sugar Land
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Fred Hutch Cancer Center Sloan Clinic 2
RECRUITING
Seattle
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Other Locations
Australia
Icon Cancer Centre Kurralta Park
RECRUITING
Kurralta Park
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Sydney Adventist Hospital
RECRUITING
Wahroonga
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Belgium
ZAS Augustinus
RECRUITING
Antwerp
AZ Maria Middelares
RECRUITING
Ghent
Chu Helora Hospital La Louviere Site Jolimont
RECRUITING
La Louvière
CHC MontLegia
RECRUITING
Liège
Brazil
NAIC Nair Antunes Instituto do Cancer
RECRUITING
Bauru
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Hospital Ana Nery Santa Cruz do Sul
RECRUITING
Santa Cruz Do Sul
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
RECRUITING
Santo André
ESHO Empresa De Servicos Hospitalares S A
RECRUITING
São Paulo
Canada
Centre de Recherche du CHUM
RECRUITING
Montreal
The Ottawa Hospital Cancer Centre
RECRUITING
Ottawa
CHU de Quebec Universite Laval
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
China
Beijing Luhe Hospital, Capital Medical University
RECRUITING
Beijing
The Third People's Hospital of Chengdu
RECRUITING
Chengdu
West China Hospital Sichuan University
RECRUITING
Chengdu
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
The Second Hospital Of Tianjin Medical University
RECRUITING
Tianjin
The Central Hospital of Wuhan
RECRUITING
Wuhan
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
France
Centre Oscar Lambret
RECRUITING
Lille
Groupe Hospitalo-Universitaire Carémeau
RECRUITING
Nîmes
Hopital Europeen Georges-Pompidou
RECRUITING
Paris
Gustave Roussy
RECRUITING
Villejuif
Japan
Kanazawa University Hospital
RECRUITING
Kanazawa
Kitasato University Hospital
RECRUITING
Sagamihara
Yokohama City University Medical Center
RECRUITING
Yokohama
Malaysia
Hospital Wanita dan Kanak-Kanak Sabah
RECRUITING
Kota Kinabalu
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Umum Sarawak
RECRUITING
Kuching
Puerto Rico
Pan American Center for Oncology Trials LLC
RECRUITING
San Juan
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Seoul
Spain
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Gral. Univ. J.M. Morales Meseguer
RECRUITING
Murcia
Hosp. Virgen Macarena
RECRUITING
Seville
Hosp. Gral. Univ. Valencia
RECRUITING
Valencia
Hosp. Clinico Univ. Lozano Blesa
RECRUITING
Zaragoza
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
Tungs' Taichung MetroHarbor Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Turkey
Ankara University Medical Faculty
RECRUITING
Ankara
Gulhane Training and Research Hospital
RECRUITING
Ankara
Istanbul University Cerrahpasa tip Fakultesi
RECRUITING
Istanbul
Koc Universitesi Hastanesi
RECRUITING
Istanbul
Medicana International Izmir
RECRUITING
Izmir
United Kingdom
Velindre Cancer Centre
RECRUITING
Cardiff
Beatson West Of Scotland Cancer Centre
RECRUITING
Glasgow
St Bartholomews Hospital
RECRUITING
London
The Royal Marsden NHS Trust
RECRUITING
London
The Newcastle upon Tyne Hospitals NHS Trust - Freeman Hospit
RECRUITING
Newcastle Upon Tyne
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
RECRUITING
Preston
Royal Marsden Hospital
RECRUITING
Sutton
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-12-19
Estimated Completion Date: 2029-07-20
Participants
Target number of participants: 800
Treatments
Experimental: Pasritamig+Docetaxel
Participants 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.
Active_comparator: Docetaxel
Participants will receive docetaxel along with prednisone as background medication.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC