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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Pasritamig
  • Docetaxel
  • Prednisone/Prednisolone

Treatment groups

800 Participants
are divided into 2 treatment groups