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A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the 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 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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 800 · Started: Dec 19, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07225946

Locations in the U.S.

ArizonaArizona Clinical Trials, Chandler
ArkansasArkansas Urology, Little Rock
CaliforniaMemorialCare Orange Coast Medical Center, Fountain Valley
University Of California San Diego, La Jolla
Cancer and Blood Specialty Clinic, Los Alamitos
Ronald Reagan UCLA Medical Center, Los Angeles
USC Norris Comprehensive Cancer Center, Los Angeles
Valkyrie Clinical Trials, Los Angeles
Kaiser Permanente Southern California, Riverside
Sharp Center for Research, San Diego
Providence Saint John s Health Center, Santa Monica
ColoradoRocky Mountain Cancer Centers, Aurora
AdventHealth Porter Oncology Research, Denver
Vail Health Shaw Cancer Center, Edwards
Grand Valley Oncology, Grand Junction
Colorado Clinical Research, Lakewood
FloridaAdventHealth Orlando, Orlando
Florida Cancer Specialists, Sarasota
GeorgiaWinship Cancer Institute Emory University, Atlanta
IllinoisDuly Health and Care, Lisle
KansasCancer Center of Kansas Heritage Plaza Medical Building, Wichita
KentuckySt Elizabeth Healthcare, Edgewood
Norton Cancer Institute, Louisville
LouisianaEast Jefferson General Hospital, Metairie
MarylandJohns Hopkins Hospital, Baltimore
Johns Hopkins Medical Institutions, Baltimore
University of Maryland, Baltimore
Chesapeake Urology Research Associates, Towson
MassachusettsMassachusetts General, Boston
MichiganProfound Research LLC at Cancer and Leukemia Center, Sterling Heights
MinnesotaHealthPartners Frauenshuh Cancer Center CRC West, Saint Louis Park
HealthPartners Cancer Center at Regions Hospital CRC East, Saint Paul
MississippiUniversity of Mississippi Medical Center, Jackson
MissouriWashington University, St Louis
NebraskaNHO Revive Research Institute, LLC, Lincoln
New JerseyAstera Cancer Care, East Brunswick
Rutgers Cancer Institute of New Jersey, New Brunswick
New YorkLaura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola
NYU Langone Health Laura and Isaac Perlmutter Cancer Center, New York
Montefiore Medical Center, The Bronx
North CarolinaDuke University Medical Center, Durham
OhioUniversity of Cincinnati, Cincinnati
OregonOregon Urology Institute, Springfield
PennsylvaniaLehigh Valley Hospital, Allentown
MidLantic Urology, Bala-Cynwyd
Penn State Milton S. Hershey Medical Center, Hershey
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center, Pittsburgh
South CarolinaCarolina Urologic Research Center, Myrtle Beach
South DakotaAvera Medical Group, Sioux Falls
Prairie Lakes Health Care System, Watertown
TennesseeTennessee Cancer Specialists, Knoxville
TexasTexas Oncology, Austin
UT Southwestern Medical Center, Dallas
Houston Metro Urology, Houston
Texas Oncology 1, Sugar Land
Renovatio Clinical, The Woodlands
VirginiaVirginia Cancer Specialists, Fairfax
WashingtonFred Hutch Cancer Center Sloan Clinic 2, Seattle
Fred Hutchinson Cancer Research Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.