Study Comparing Pasritamig and Docetaxel to Docetaxel Alone in Patients with Advanced Prostate Cancer

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT07225946

This clinical trial is exploring whether combining the drug pasritamig with docetaxel can help delay the progression of advanced prostate cancer compared to using docetaxel alone. The study focuses on patients whose cancer continues to grow despite low levels of male hormones.

Patient Parameters

Program Overview

The aim of this study is to determine if the combination of pasritamig and docetaxel can extend the time before prostate cancer worsens, as seen on scans, compared to treatment with just docetaxel. This study is for patients with metastatic castration-resistant prostate cancer, which is a type of prostate cancer that keeps growing even when male hormone levels are low.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer.
  • Cancer must have spread to other parts of the body at the time of screening.
  • Must be receiving ongoing hormone therapy to lower male hormone levels or have had surgery to remove the testicles, with testosterone levels at or below 50 ng/dL at screening.
  • Have previously tried at least one treatment targeting androgen receptors but no more than two, and must have stopped these treatments before joining the study.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have a history of prostate cancer spreading to the brain or spinal fluid.
  • Have known BRCA 1/2 mutations and have not been treated with a PARP inhibitor, unless unavailable or not suitable.
  • Have another active cancer that could interfere with the study.
  • Have received chemotherapy for prostate cancer in any setting.
  • Have been treated with therapies targeting human kallikrein 2 (KLK-2).

Locations

FACILITYZIPCITYSTATE
Arkansas Urology72211Little RockArkansas
Valkyrie Clinical Trials90067Los AngelesCalifornia
Kaiser Permanente Southern California92505RiversideCalifornia
Grand Valley Oncology81505Grand JunctionColorado
Colorado Clinical Research80228LakewoodColorado
Duly Health and Care60532LisleIllinois
Cancer Center of Kansas Heritage Plaza Medical Building67214WichitaKansas
East Jefferson General Hospital70006MetairieLouisiana
Profound Research LLC at Cancer and Leukemia Center48314Sterling HeightsMichigan
HealthPartners Frauenshuh Cancer Center CRC West55426Saint Louis ParkMinnesota

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