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Clinical Trials in China / NCT07225946
Recruiting Phase 3

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

NCT07225946 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2025-12-19
Last updated
2026-08-28

Condition(s) studied

Prostatic Neoplasms, Castration-Resistant

Investigational drug(s) / intervention(s)

PasritamigDocetaxelPrednisone/Prednisolone

Pasritamig: Pasritamig will be administered.

Docetaxel: Docetaxel will be administered.

Prednisone/Prednisolone: Prednisone/Prednisolone will be administered.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (152)

FacilityCityRegionStatus
Arizona Clinical Trials Chandler Arizona Recruiting
Arkansas Urology Little Rock Arkansas Recruiting
MemorialCare Orange Coast Medical Center Fountain Valley California Recruiting
University Of California San Diego La Jolla California Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
Kaiser Permanente Southern California Riverside California Recruiting
Sharp Center for Research San Diego California Recruiting
Providence Saint John s Health Center Santa Monica California Recruiting
Rocky Mountain Cancer Centers Aurora Colorado Recruiting
Vail Health Shaw Cancer Center Edwards Colorado Recruiting
Grand Valley Oncology Grand Junction Colorado Recruiting
Colorado Clinical Research Lakewood Colorado Recruiting
AdventHealth Orlando Orlando Florida Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Winship Cancer Institute Emory University Atlanta Georgia Recruiting
Duly Health and Care Lisle Illinois Recruiting
Cancer Center of Kansas Heritage Plaza Medical Building Wichita Kansas Recruiting
St Elizabeth Healthcare Edgewood Kentucky Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
East Jefferson General Hospital Metairie Louisiana Recruiting
University of Maryland Baltimore Maryland Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Johns Hopkins Medical Institutions Baltimore Maryland Recruiting
Chesapeake Urology Research Associates Towson Maryland Recruiting
Profound Research LLC at Cancer and Leukemia Center Sterling Heights Michigan Recruiting
HealthPartners Frauenshuh Cancer Center CRC West Saint Louis Park Minnesota Recruiting
HealthPartners Cancer Center at Regions Hospital CRC East Saint Paul Minnesota Recruiting
University of Mississippi Medical Center Jackson Mississippi Recruiting
Washington University St Louis Missouri Recruiting
NHO Revive Research Institute, LLC Lincoln Nebraska Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island Mineola New York Recruiting
NYU Langone Health Laura and Isaac Perlmutter Cancer Center New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Oregon Urology Institute Springfield Oregon Recruiting
Lehigh Valley Hospital Allentown Pennsylvania Recruiting

+ 112 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07225946 on ClinicalTrials.gov ↗ ← All trials in China