A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer
Janssen Research & Development, LLC
Summary
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) 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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Have histologically confirmed adenocarcinoma of the prostate * Have disease that is metastatic at the time of the screening 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 milliliter (ng/dL) (\<= 1.73 nanomoles per Liter \[nmol/L\]) at screening * Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) bu…
Interventions
- DrugPasritamig
Pasritamig will be administered.
- DrugDocetaxel
Docetaxel will be administered.
- DrugPrednisone
Prednisone will be administered.
Locations (97)
- Arizona Clinical TrialsChandler, Arizona
- Arkansas UrologyLittle Rock, Arkansas
- University Of California San DiegoLa Jolla, California
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Valkyrie Clinical TrialsLos Angeles, California
- Kaiser Permanente Southern CaliforniaRiverside, California