A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Amgen

Summary

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).

Eligibility

Age range: 18+ years
Sex: Male
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study-specific activities/procedures. * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * Participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. * mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan…

Interventions

Drug
Xaluritamig
Short-term IV infusion
Drug
Abiraterone
Oral tablets
Drug
Enzalutamide
Oral tablets
Drug
Cabazitaxel
IV infusion

Locations (164)

University of Alabama at Birmingham
Birmingham, Alabama
City of Hope National Medical Center
Duarte, California
Providence Saint Jude Medical Center
Fullerton, California
Cedars Sinai Medical Center
Los Angeles, California
University of California Irvine
Orange, California
University of California San Francisco
San Francisco, California