Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study 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) 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-redirecting 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, Pasritamig, 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 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

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) 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

Locations

  • University Of California San Diego accepting new patients
    La Jolla California 92037 United States
  • Sharp Center for Research accepting new patients
    San Diego California 92123 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