A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Amgen

Summary

The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).

Eligibility

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

Detailed criteria

Inclusion Criteria: * Participant has provided informed consent before 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. * Metastatic castration-resistant prostate cancer (mCRPC) with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT),…

Interventions

Drug
Xaluritamig
Xaluritamig will be administered IV.
Drug
Abiraterone acetate
Abiraterone acetate will be administered orally.
Drug
Docetaxel
Docetaxel will be administered IV.
Drug
Cabazitaxel
Cabazitaxel will be administered IV.

Locations (125)

City of Hope Cancer Center Phoenix
Goodyear, Arizona
City of Hope National Medical Center
Duarte, California
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California
Providence Saint Jude Medical Center
Fullerton, California
Rocky Mountain Cancer Centers
Denver, Colorado
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware