Trial NCT07225946
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
- Phase
- Phase 3
- Sponsor
- Janssen Research & Development, LLC
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 1Performance status
Exclusion criteria:
* Known history of either brain or leptomeningeal prostate cancer metastasesBrain 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)Prior malignancy
* Received cytotoxic chemotherapy for prostate cancer in any setting
* Received prior treatment with human kallikrein 2 (KLK-2) directed therapies
Restrictions found (3)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusConditionalinclusion
ECOG 0 to 1
Show in the text - Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General · Boston, Suffolk County