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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Men

Full eligibility 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), 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.

Exclusion Criteria:

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.

About the study

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).

What is being tested

Sponsor: Amgen · Participants: 750 · Started: Nov 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07213674

Locations in the U.S.

ArizonaCity of Hope Cancer Center Phoenix, Goodyear
University of Arizona Cancer Center, Tucson
CaliforniaCity of Hope National Medical Center, Duarte
City of Hope Orange County Lennar Foundation Cancer Center, Duarte
Providence Saint Jude Medical Center, Fullerton
University of California Irvine, Orange
University of California San Francisco, San Francisco
Providence Saint Johns Health Center, Santa Monica
ColoradoRocky Mountain Cancer Centers, Denver
ConnecticutHartford HealthCare Cancer Institute at Hartford Hospital, Hartford
DelawareMedical Oncology Hematology Consultants Helen F Graham Cancer Center, Newark
FloridaMoffitt Cancer Center, Tampa
GeorgiaCity of Hope Atlanta, Newnan
IllinoisUniversity of Illinois Chicago, Chicago
Cancer Care Specialists of Illinois, Decatur
Midwestern Regional Medical Center dba City of Hope Chicago, Zion
KansasUniversity of Kansas Medical Center, Westwood
KentuckyNorton Cancer Institute, Louisville
University of Louisville Health - James Graham Brown Cancer Center, Louisville
MarylandJohns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center, Baltimore
University of Maryland Greenebaum Cancer Center, Baltimore
MichiganBarbara Ann Karmanos Cancer Institute, Lansing
MinnesotaMinnesota Oncology Hematology PA, Minneapolis
University of Minnesota Medical Center Fairview, Minneapolis
New YorkHematology Oncology Association of Central New York, East Syracuse
Memorial Sloan Kettering Cancer Center, New York
OhioOncology Hematology Care Incorporated, Cincinnati
The Ohio State University, Columbus
Dayton Physicians LLC Dayton, Dayton
OklahomaHightower Clinical, Oklahoma City
OregonOregon Oncology Specialists, Salem
PennsylvaniaUniversity of Pittsburgh Medical Center, Pittsburgh
South CarolinaSouth Texas Accelerated Research Therapeutics - Carolinas, Myrtle Beach
TennesseeSarah Cannon Research Institute Oncology Partners, Nashville
United States Oncology Regulatory Affairs Corporate Office, Nashville
TexasThe Center for Cancer and Blood Disorders, Arlington
University of Texas Southwestern Medical Center, Dallas
Renovatio Clinical, Houston
Texas Oncology - Northeast Texas, Tyler
US Oncology Research Investigational Products Center, Tyler
VirginiaUniversity of Virginia Cancer Center, Charlottesville
Virginia Cancer Specialists PC, Leesburg
Bon Secours Cancer Institute at Saint Francis, Midlothian
Virginia Oncology Associates, Norfolk
WashingtonNorthwest Medical Specialties, PLLC, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.