RecruitingRecruiting
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT07225946 · Janssen Research & Development, LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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 criteria
Inclusion criteria:
* 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
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) 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
Study design
Enrollment target: 800 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-19
Estimated completion: 2029-07-20
Last updated: 2026-06-05
Interventions
Drug: PasritamigDrug: DocetaxelDrug: Prednisone
Primary outcomes
- • Radiographic Progression-Free Survival (rPFS) Assessed by BICR (Up to approximately 1 years 10 months)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (136)
Arizona Clinical TrialsRecruiting
Chandler, Arizona, United States
Arkansas UrologyRecruiting
Little Rock, Arkansas, United States
MemorialCare Orange Coast Medical CenterRecruiting
Fountain Valley, California, United States
University Of California San DiegoRecruiting
La Jolla, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
Kaiser Permanente Southern CaliforniaRecruiting
Riverside, California, United States
Sharp Center for ResearchRecruiting
San Diego, California, United States
Providence Saint John s Health CenterRecruiting
Santa Monica, California, United States
Rocky Mountain Cancer CentersRecruiting
Aurora, Colorado, United States
Grand Valley OncologyRecruiting
Grand Junction, Colorado, United States
Colorado Clinical ResearchRecruiting
Lakewood, Colorado, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Winship Cancer Institute Emory UniversityRecruiting
Atlanta, Georgia, United States
Duly Health and CareRecruiting
Lisle, Illinois, United States
Cancer Center of Kansas Heritage Plaza Medical BuildingRecruiting
Wichita, Kansas, United States
St Elizabeth HealthcareRecruiting
Edgewood, Kentucky, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
East Jefferson General HospitalRecruiting
Metairie, Louisiana, United States
University of MarylandRecruiting
Baltimore, Maryland, United States
Johns Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Johns Hopkins Medical InstitutionsRecruiting
Baltimore, Maryland, United States
Chesapeake Urology Research AssociatesRecruiting
Towson, Maryland, United States
Profound Research LLC at Cancer and Leukemia CenterRecruiting
Sterling Heights, Michigan, United States
HealthPartners Frauenshuh Cancer Center CRC WestRecruiting
Saint Louis Park, Minnesota, United States
HealthPartners Cancer Center at Regions Hospital CRC EastRecruiting
Saint Paul, Minnesota, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
NHO Revive Research Institute, LLCRecruiting
Lincoln, Nebraska, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long IslandRecruiting
Mineola, New York, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer CenterRecruiting
New York, New York, United States
Montefiore Medical CenterRecruiting
The Bronx, New York, United States
University of CincinnatiRecruiting
Cincinnati, Ohio, United States
Oregon Urology InstituteRecruiting
Springfield, Oregon, United States
Lehigh Valley HospitalRecruiting
Allentown, Pennsylvania, United States
MidLantic UrologyRecruiting
Bala-Cynwyd, Pennsylvania, United States
Penn State Milton S. Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Avera Medical GroupRecruiting
Sioux Falls, South Dakota, United States
Tennessee Cancer SpecialistsRecruiting
Knoxville, Tennessee, United States
Texas OncologyRecruiting
Austin, Texas, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Houston Metro UrologyRecruiting
Houston, Texas, United States
Texas Oncology 1Recruiting
Sugar Land, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Fred Hutch Cancer Center Sloan Clinic 2Recruiting
Seattle, Washington, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
Warringal Private HospitalRecruiting
Heidelberg, Australia
Icon Cancer Centre Kurralta ParkRecruiting
Kurralta Park, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Australia
Sydney Adventist HospitalRecruiting
Wahroonga, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Australia
AZORG campus Aalst MoorselbaanRecruiting
Aalst, Belgium
ZAS AugustinusRecruiting
Antwerp, Belgium
AZ Maria MiddelaresRecruiting
Ghent, Belgium
Chu Helora Hospital La Louviere Site JolimontRecruiting
La Louvière, Belgium
CHC MontLegiaRecruiting
Liège, Belgium
NAIC Nair Antunes Instituto do CancerRecruiting
Bauru, Brazil
Liga Norte Riograndense Contra O CancerRecruiting
Natal, Brazil
Hospital Ana Nery Santa Cruz do SulRecruiting
Santa Cruz do Sul, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e OncologiaRecruiting
Santo André, Brazil
ESHO Empresa De Servicos Hospitalares S ARecruiting
São Paulo, Brazil
The Ottawa Hospital Cancer CentreRecruiting
Ottawa, Ontario, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Centre de Recherche du CHUMRecruiting
Montreal, Quebec, Canada
CHU de Quebec Universite LavalRecruiting
Québec, Quebec, Canada
Beijing Cancer HospitalRecruiting
Beijing, China
Beijing Luhe Hospital, Capital Medical UniversityRecruiting
Beijing, China
The Third People's Hospital of ChengduRecruiting
Chengdu, China
West China Hospital Sichuan UniversityRecruiting
Chengdu, China
Chongqing University Cancer HospitalRecruiting
Chongqing, China
Sun Yat Sen University Cancer CenterRecruiting
Guangzhou, China
The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of MedicineRecruiting
Hangzhou, China
Nanjing Drum Tower HospitalRecruiting
Nanjing, China
Huashan Hospital Fudan UniversityRecruiting
Shanghai, China
Shanghai General HospitalRecruiting
Shanghai, China
The Second Hospital Of Tianjin Medical UniversityRecruiting
Tianjin, China
The Central Hospital of WuhanRecruiting
Wuhan, China
The First Affiliated Hospital of Xian Jiaotong UniversityRecruiting
Xi'an, China
Centre Jean PerrinRecruiting
Clermont-Ferrand, France
Centre Oscar LambretRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
Groupe Hospitalo-Universitaire CarémeauRecruiting
Nîmes, France
Hopital Europeen Georges-PompidouRecruiting
Paris, France
Gustave RoussyRecruiting
Villejuif, France
Urologicum DuisburgRecruiting
Duisburg, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Studienpraxis Urologie Drs. FeyerabendRecruiting
Nürtingen, Germany
Azienda Ospedaliero Universitaria CareggiRecruiting
Florence, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Italy
Istituto Europeo di OncologiaRecruiting
Milan, Italy
Istituto Nazionale Tumori Regina ElenaRecruiting
Roma, Italy
Juntendo University HospitalRecruiting
Bunkyō City, Japan
Kansai Medical University HospitalRecruiting
Hirakata, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Japan
Kitasato University HospitalRecruiting
Sagamihara, Japan
Shizuoka Cancer CenterRecruiting
Sunto Gun, Japan
Yokohama City University Medical CenterRecruiting
Yokohama, Japan
Hospital Wanita dan Kanak-Kanak SabahRecruiting
Kota Kinabalu, Malaysia
Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
Pantai Hospital Kuala LumpurRecruiting
Kuala Lumpur, Malaysia
University Malaya Medical CentreRecruiting
Kuala Lumpur, Malaysia
Hospital Umum SarawakRecruiting
Kuching, Malaysia
Pan American Center for Oncology Trials LLCRecruiting
San Juan, Puerto Rico
National Cancer CenterRecruiting
Goyang-si, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea Seoul St Marys HospitalRecruiting
Seoul, South Korea
Hosp. Univ. Ramon Y CajalRecruiting
Madrid, Spain
Hosp. Univ. 12 de OctubreRecruiting
Madrid, Spain
Hosp. Gral. Univ. J.M. Morales MeseguerRecruiting
Murcia, Spain
Hosp. Virgen MacarenaRecruiting
Seville, Spain
Hosp. Gral. Univ. ValenciaRecruiting
Valencia, Spain
Hosp. Clinico Univ. Lozano BlesaRecruiting
Zaragoza, Spain
China Medical University HospitalRecruiting
Taichung, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
Tungs' Taichung MetroHarbor HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan, Taiwan
Adana City HospitalRecruiting
Adana, Turkey (Türkiye)
Gulhane Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Ankara University Medical FacultyRecruiting
Ankara, Turkey (Türkiye)
Istanbul University Cerrahpasa tip FakultesiRecruiting
Istanbul, Turkey (Türkiye)
Koc Universitesi HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Medicana International IzmirRecruiting
Izmir, Turkey (Türkiye)
Velindre Cancer CentreRecruiting
Cardiff, United Kingdom
Beatson West Of Scotland Cancer CentreRecruiting
Glasgow, United Kingdom
St Bartholomews HospitalRecruiting
London, United Kingdom
The Royal Marsden NHS TrustRecruiting
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Trust - Freeman HospitRecruiting
Newcastle upon Tyne, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston HospitalRecruiting
Preston, United Kingdom
Royal Marsden HospitalRecruiting
Sutton, United Kingdom