USClinicalTrials.govClinical trialPhase 3Recruiting
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Official record
- Identifier
NCT07225946- Recruiting locations
countries
United StatesAustraliaBelgiumBrazilCanadaChinaFranceGermanyItalyJapanMalaysiaPuerto RicoSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom- Interventions studied
- PasritamigDocetaxelPrednisone/Prednisolone
- Lead sponsor
- Janssen Research & Development, LLC
- Target enrolment
- 800 participants
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Status
- Recruiting
- First posted
- Nov 10, 2025
- Last updated on the registry
- Jul 30, 2026
- Age
- 18 Years
- Sex
- ALL
- Study contact
- The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.
- Eligibility criteria
Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.
Inclusion criteria: * 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 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) * Received cytotoxic chemotherapy for prostate cancer in any setting * Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
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