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

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

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07225946
Protocol IDs
78278343PCR3003 (primary)
NCI-2025-09042
2025
2025-522713-29-00
78278343PCR3003
Study Sponsor
Janssen Research & Development, LLC

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).

Eligibility

  1. Have histologically confirmed adenocarcinoma of the prostate
  2. 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
  3. 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
  4. 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
  5. Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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