Home › Castration-Resistant Prostatic Cancer › NCT07225946
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
- Pasritamig (drug)
- Docetaxel (drug)
- Prednisone/Prednisolone (drug)
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.
| Arizona | Arizona Clinical Trials, Chandler |
| Arkansas | Arkansas Urology, Little Rock Highlands Oncology Group, Springdale |
| California | MemorialCare 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 |
| Colorado | Rocky Mountain Cancer Centers, Aurora AdventHealth Porter Oncology Research, Denver Vail Health Shaw Cancer Center, Edwards Grand Valley Oncology, Grand Junction Colorado Clinical Research, Lakewood |
| Florida | AdventHealth Orlando, Orlando Memorial Cancer Institute, Pembroke Pines Florida Cancer Specialists, Sarasota |
| Georgia | Winship Cancer Institute Emory University, Atlanta |
| Illinois | Duly Health and Care, Lisle |
| Kansas | Cancer Center of Kansas Heritage Plaza Medical Building, Wichita |
| Kentucky | St Elizabeth Healthcare, Edgewood Norton Cancer Institute, Louisville |
| Louisiana | East Jefferson General Hospital, Metairie |
| Maryland | Johns Hopkins Hospital, Baltimore Johns Hopkins Medical Institutions, Baltimore University of Maryland, Baltimore Center for Cancer and Blood Disorders, Bethesda Chesapeake Urology Research Associates, Towson |
| Massachusetts | Massachusetts General, Boston |
| Michigan | Profound Research LLC at Cancer and Leukemia Center, Sterling Heights |
| Minnesota | HealthPartners Frauenshuh Cancer Center CRC West, Saint Louis Park HealthPartners Cancer Center at Regions Hospital CRC East, Saint Paul |
| Mississippi | University of Mississippi Medical Center, Jackson |
| Missouri | Washington University, St Louis |
| Nebraska | NHO Revive Research Institute, LLC, Lincoln |
| New Jersey | Cooper Health System MD Anderson Cancer Center at Cooper, Camden Astera Cancer Care, East Brunswick Rutgers Cancer Institute of New Jersey, New Brunswick |
| New York | Laura & 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 Carolina | Duke University Medical Center, Durham |
| Ohio | Gabrail Cancer Center, Canton University of Cincinnati, Cincinnati Metrohealth Medical Center, Cleveland |
| Oregon | Oregon Urology Institute, Springfield |
| Pennsylvania | Lehigh 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 Carolina | Carolina Urologic Research Center, Myrtle Beach |
| South Dakota | Avera Medical Group, Sioux Falls Prairie Lakes Health Care System, Watertown |
| Tennessee | Tennessee Cancer Specialists, Knoxville |
| Texas | Texas Oncology, Austin UT Southwestern Medical Center, Dallas Houston Metro Urology, Houston Texas Oncology 1, Sugar Land Renovatio Clinical, The Woodlands |
| Virginia | Virginia Cancer Specialists, Fairfax |
| Washington | Fred Hutch Cancer Center Sloan Clinic 2, Seattle Fred Hutchinson Cancer Research Center, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.