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-engaging Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
About This Trial
- This study is testing whether adding a new drug called pasritamig to a standard chemotherapy drug called docetaxel works better at slowing down cancer growth than chemotherapy alone.
- It is designed for men with advanced prostate cancer that has spread to other areas of the body and continues to grow despite hormone-lowering therapies.
- To be eligible, patients must have already tried certain newer hormone medications, but cannot have previously received chemotherapy for their prostate cancer.
- Patients should also know that they cannot join this study if their cancer has spread to the brain or if they have had another recent cancer.
More Information
- 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).
Who Can Enroll
- Age Range: 18 years and older
- Gender: All
- Who This Trial is For: This study is testing whether adding a new drug called pasritamig to a standard chemotherapy drug called docetaxel works better at slowing down cancer growth than chemotherapy alone.
Study Details
- Start Date: December 19, 2025
- Lead Sponsor: Janssen Research & Development, LLC
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
Treatments
- Drug: Pasritamig
- Drug: Docetaxel
- Drug: Prednisone/Prednisolone