Study of Pasritamig with Docetaxel for Metastatic Castration-Resistant Prostate Cancer

This study is looking at whether a combination of pasritamig and docetaxel can help people with metastatic castration-resistant prostate cancer (mCRPC; prostate cancer that has spread and continues to grow despite low male hormone levels). You might be able to join if you have prostate adenocarcinoma that has spread (metastatic disease) and you are receiving ongoing hormone therapy or have had a specific surgery. The main goal is to see if this combination treatment can extend the time until your cancer worsens on scans (radiographic progression-free survival) compared to docetaxel alone. The study plans to enroll about 800 participants, but its current recruitment status is unclear.

Study design
This study compares treatment with pasritamig and docetaxel to docetaxel alone. It plans to enroll about 800 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome will be measured for up to approximately 1 year and 10 months after starting treatment.

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NCT07225946

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~800 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PasritamigDocetaxelPrednisone/Prednisolone

At a glance

Recruiting sites
152 of 152 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR)
Measured over Up to approximately 1 years 10 months
Prostatic Neoplasms, Castration-Resistant
152 sites across 45 states
China15
California8
France8
Japan7
Spain7
United Kingdom7
Germany6
Italy6
  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

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Eligibility criteria

Inclusion

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
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion

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
Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
  • Radiographic Progression-Free Survival (rPFS) by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan Assessed by Blinded Independent Central Review (BICR)Up to approximately 1 years 10 months

    rPFS by CT/MRI or bone scan 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.