Prostatic Neoplasms, Castration-Resistant
Conditions
Interventions
[Arms]
Experimental: Pasritamig+Docetaxel
Participants will receive pasritamig along with docetaxel until the end of trial (EOT) visit or until confirmed radiographic progression by blinded independen
Sponsors
Fujikawa Ei
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Radiographic Progression-Free Survival (rPFS) Assessed by BICR rPFS is assessed by BICR and is defined as the time from the date of randomization to the first date of radiographic disease progression, or death due to any cause, whichever occurs first. [Time Frame: Up to approximately 1 years 10 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| Refer to Appendix | — |
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed