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A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT07225946•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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) 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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (53)

Arkansas Urology

Little Rock, Arkansas, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Kaiser Permanente Southern California

Riverside, California, United States

Grand Valley Oncology

Grand Junction, Colorado, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Duly Health and Care

Lisle, Illinois, United States

Cancer Center of Kansas Heritage Plaza Medical Building

Wichita, Kansas, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Profound Research LLC at Cancer and Leukemia Center

Sterling Heights, Michigan, United States

HealthPartners Frauenshuh Cancer Center CRC West

Saint Louis Park, Minnesota, United States

Key Dates

Start Date

December 19, 2025

Primary Completion Date

November 19, 2027

Completion Date

July 20, 2029

Last Updated

March 13, 2026

Enrollment

800

ESTIMATED participants

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

Pasritamig

DRUG

Docetaxel

DRUG

Prednisone

DRUG

Contacts

Study Contact

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer

A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer

Development and Prospective Validation of a Pathology-Based Artificial Intelligence Model for Predicting the Time to Castration Resistance of Prostate Cancer