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

Purpose

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).

Condition

  • Prostatic Neoplasms, Castration-Resistant

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Pasritamig
    Pasritamig will be administered.
    Other names:
    • JNJ-78278343
  • Drug: Docetaxel
    Docetaxel will be administered.
Active Comparator
Docetaxel 		Participants will receive docetaxel along with prednisone/prednisolone as background medication.
  • Drug: Pasritamig
    Pasritamig will be administered.
    Other names:
    • JNJ-78278343
  • Drug: Docetaxel
    Docetaxel will be administered.
  • Drug: Prednisone/Prednisolone
    Prednisone/Prednisolone will be administered.

Recruiting Locations

Arizona Clinical Trials
Chandler, Arizona 85225

Arkansas Urology
Little Rock, Arkansas 72211

MemorialCare Orange Coast Medical Center
Fountain Valley, California 92708

University Of California San Diego
La Jolla, California 92037

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033

Valkyrie Clinical Trials
Los Angeles, California 90067

Kaiser Permanente Southern California
Riverside, California 92505

Sharp Center for Research
San Diego, California 92123

Providence Saint John s Health Center
Santa Monica, California 90404

Rocky Mountain Cancer Centers
Aurora, Colorado 80012

Vail Health Shaw Cancer Center
Edwards, Colorado 81632

Grand Valley Oncology
Grand Junction, Colorado 81505

Colorado Clinical Research
Lakewood, Colorado 80228

AdventHealth Orlando
Orlando, Florida 32803

Florida Cancer Specialists
Sarasota, Florida 34232

Winship Cancer Institute Emory University
Atlanta, Georgia 30322

Duly Health and Care
Lisle, Illinois 60532

Cancer Center of Kansas Heritage Plaza Medical Building
Wichita, Kansas 67214

St Elizabeth Healthcare
Edgewood, Kentucky 41017

Norton Cancer Institute
Louisville, Kentucky 40207

East Jefferson General Hospital
Metairie, Louisiana 70006

University of Maryland
Baltimore, Maryland 21201

Johns Hopkins Hospital
Baltimore, Maryland 21287

Johns Hopkins Medical Institutions
Baltimore, Maryland 21287

Chesapeake Urology Research Associates
Towson, Maryland 21204

Profound Research LLC at Cancer and Leukemia Center
Sterling Heights, Michigan 48314

HealthPartners Frauenshuh Cancer Center CRC West
Saint Louis Park, Minnesota 55426

HealthPartners Cancer Center at Regions Hospital CRC East
Saint Paul, Minnesota 55101

University of Mississippi Medical Center
Jackson, Mississippi 39216

Washington University
St Louis, Missouri 63110

NHO Revive Research Institute, LLC
Lincoln, Nebraska 68506

Astera Cancer Care
East Brunswick, New Jersey 08816

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York 10016

Montefiore Medical Center
The Bronx, New York 10461

University of Cincinnati
Cincinnati, Ohio 45219

Oregon Urology Institute
Springfield, Oregon 97477

Lehigh Valley Hospital
Allentown, Pennsylvania 18103

MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004

Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033

University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232

Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572

Avera Medical Group
Sioux Falls, South Dakota 57105

Tennessee Cancer Specialists
Knoxville, Tennessee 37909

Texas Oncology
Austin, Texas 78731

UT Southwestern Medical Center
Dallas, Texas 75390

Houston Metro Urology
Houston, Texas 77027

Texas Oncology 1
Sugar Land, Texas 77479

Virginia Cancer Specialists
Fairfax, Virginia 22031

Fred Hutch Cancer Center Sloan Clinic 2
Seattle, Washington 98109

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109

Pan American Center for Oncology Trials LLC
San Juan, Puerto Rico 935

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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