A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Recruiting now · Phase 3

Conditions studied: Metastatic Castration-resistant Prostate Cancer

In brief

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).

Key facts

Study ID: NCT07213674
Run by: Amgen
People needed: 750
Starts: 2025-11-28
Expected to finish: 2032-08-30
Last updated by the study team: 2026-07-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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), magnetic resonance imaging (MRI), or bone scan imaging obtained within 28 days before enrollment.
Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria:
Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum start value is 2.0 ng/mL.
Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.
Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria).
Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required.
Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate organ function.

You may not qualify if…

Disease Related:
Participants with a history of central nervous system (CNS) metastases.
Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.
Prior/Concomitant Therapy:
Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
Prior disease progression on or intolerance to abiraterone.
Prior treatment with any chemotherapy regimen in the mCRPC setting and/or > 6 cycles of docetaxel treatment in the mHSPC setting.
Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions:
Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment.
Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]) is permitted.
Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment.
Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment.
Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities.
Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy.
Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.
Prior CD3-directed therapy.

Where it is running

City of Hope National Medical Center — Duarte, California, United States (enrolling)
City of Hope Orange County Lennar Foundation Cancer Center — Duarte, California, United States (enrolling)
Providence Saint Jude Medical Center — Fullerton, California, United States (enrolling)
University of California Irvine — Orange, California, United States (enrolling)
Providence Saint Johns Health Center — Santa Monica, California, United States (enrolling)
Rocky Mountain Cancer Centers — Denver, Colorado, United States (enrolling)
Hartford HealthCare Cancer Institute at Hartford Hospital — Hartford, Connecticut, United States (enrolling)
Medical Oncology Hematology Consultants Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
City of Hope Atlanta — Newnan, Georgia, United States (enrolling)
University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
Midwestern Regional Medical Center dba City of Hope Chicago — Zion, Illinois, United States (enrolling)
University of Kansas Medical Center — Westwood, Kansas, United States (enrolling)
University of Louisville Health - James Graham Brown Cancer Center — Louisville, Kentucky, United States (enrolling)
Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States (enrolling)
Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
Barbara Ann Karmanos Cancer Institute — Lansing, Michigan, United States (enrolling)
Minnesota Oncology Hematology PA — Minneapolis, Minnesota, United States (enrolling)
University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States (enrolling)
Hematology Oncology Association of Central New York — East Syracuse, New York, United States (enrolling)
Oncology Hematology Care Incorporated — Cincinnati, Ohio, United States (enrolling)
Hightower Clinical — Oklahoma City, Oklahoma, United States (enrolling)
Oregon Oncology Specialists — Salem, Oregon, United States (enrolling)
City of Hope Cancer Center Phoenix — Goodyear, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.