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

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

Recruiting
18 years and older
All
Phase 3

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Overview

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

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

Study details
    Prostatic Neoplasms
    Castration-Resistant

NCT07225946

Janssen Research & Development, LLC

31 January 2026

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