Recruiting

Phase 3

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

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07225946

Conditions

Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pasritamig

Docetaxel

Prednisone/Prednisolone

Study Details

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 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).

Conditions

Prostatic Neoplasms, Castration-Resistant

Study ID

NCT07225946

Start date

Dec 19, 2025

Status verified date

Aug, 2026

Completion date

Jul 20, 2029

Anticipated

Primary completion date

Nov 19, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Docetaxel

Participants will receive docetaxel along with prednisone/prednisolone as background medication.

Interventions

Pasritamig

Pasritamig will be administered.

Docetaxel

Docetaxel will be administered.

Prednisone/Prednisolone

Prednisone/Prednisolone will be administered.

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

Locations

Arizona Clinical Trials

Recruiting

Chandler, Arizona, United States, 85225

Arkansas Urology

Recruiting

Little Rock, Arkansas, United States, 72211

MemorialCare Orange Coast Medical Center

Recruiting

Fountain Valley, California, United States, 92708

University Of California San Diego

Recruiting

La Jolla, California, United States, 92037

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Kaiser Permanente Southern California

Recruiting

Riverside, California, United States, 92505

Sharp Center for Research

Recruiting

San Diego, California, United States, 92123

Providence Saint John s Health Center

Recruiting

Santa Monica, California, United States, 90404

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

Vail Health Shaw Cancer Center

Recruiting

Edwards, Colorado, United States, 81632

Grand Valley Oncology

Recruiting

Grand Junction, Colorado, United States, 81505

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Winship Cancer Institute Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Duly Health and Care

Recruiting

Lisle, Illinois, United States, 60532

Cancer Center of Kansas Heritage Plaza Medical Building

Recruiting

Wichita, Kansas, United States, 67214

St Elizabeth Healthcare

Recruiting

Edgewood, Kentucky, United States, 41017

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

East Jefferson General Hospital

Recruiting

Metairie, Louisiana, United States, 70006

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Johns Hopkins Medical Institutions

Recruiting

Baltimore, Maryland, United States, 21287

Chesapeake Urology Research Associates

Recruiting

Towson, Maryland, United States, 21204

Profound Research LLC at Cancer and Leukemia Center

Recruiting

Sterling Heights, Michigan, United States, 48314

HealthPartners Frauenshuh Cancer Center CRC West

Recruiting

Saint Louis Park, Minnesota, United States, 55426

HealthPartners Cancer Center at Regions Hospital CRC East

Recruiting

Saint Paul, Minnesota, United States, 55101

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Washington University

Recruiting

St Louis, Missouri, United States, 63110

NHO Revive Research Institute, LLC

Recruiting

Lincoln, Nebraska, United States, 68506

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Recruiting

Mineola, New York, United States, 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Oregon Urology Institute

Recruiting

Springfield, Oregon, United States, 97477

Lehigh Valley Hospital

Recruiting

Allentown, Pennsylvania, United States, 18103

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Avera Medical Group

Recruiting

Sioux Falls, South Dakota, United States, 57105

Tennessee Cancer Specialists

Recruiting

Knoxville, Tennessee, United States, 37909

Texas Oncology

Recruiting

Austin, Texas, United States, 78731

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Houston Metro Urology

Recruiting

Houston, Texas, United States, 77027

Texas Oncology 1

Recruiting

Sugar Land, Texas, United States, 77479

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Fred Hutch Cancer Center Sloan Clinic 2

Recruiting

Seattle, Washington, United States, 98109

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109

British Columbia Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

British Columbia Cancer Agency Vancouver Island Centre

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Centre de Recherche du CHUM

Recruiting

Montreal, Quebec, Canada, H2X 0A9

CHU de Quebec Universite Laval

Recruiting

Québec, Quebec, Canada, G1R 2J6

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.