A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
a study on Prostate Cancer Metastatic Castration-Resistant Prostate Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedstudy ends around
Description
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).
Official Title
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
Keywords
Prostatic Neoplasms, Castration-Resistant, Castration-Resistant Prostatic Neoplasms, Docetaxel, Prednisone, Prednisolone, Pasritamig, Prednisone/Prednisolone, Pasritamig+Docetaxel
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 99mTc 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 99mTc 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
You CAN'T join if...
- 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
Locations
- University Of California San Diego
accepting new patients
La Jolla California 92037 United States - Providence Saint John s Health Center
accepting new patients
Santa Monica California 90404 United States - Valkyrie Clinical Trials
accepting new patients
Los Angeles California 90067 United States - MemorialCare Orange Coast Medical Center
accepting new patients
Fountain Valley California 92708 United States - Sharp Center for Research
accepting new patients
San Diego California 92123 United States - USC Norris Comprehensive Cancer Center
accepting new patients
Los Angeles California 90033 United States - Cancer and Blood Specialty Clinic
accepting new patients
Los Alamitos California 90720 United States - Kaiser Permanente Southern California
accepting new patients
Riverside California 92505 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Janssen Research & Development, LLC
- ID
- NCT07225946
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 800 study participants
- Last Updated
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