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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Amgen
Study ID
NCT07213674
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xaluritamig — DRUG
    Xaluritamig will be administered IV.
  • Abiraterone acetate — DRUG
    Abiraterone acetate will be administered orally.
  • Docetaxel — DRUG
    Docetaxel will be administered IV.
  • Cabazitaxel — DRUG
    Cabazitaxel will be administered IV.

Study Details

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 Dates

Start date
Nov 28, 2025
Status verified
Jun 2026
Primary completion
Jan 7, 2030
Completion
Aug 30, 2032

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Xaluritamig Plus Abiraterone
    Participants will be randomized to receive xaluritamig in combination with abiraterone acetate.
  • Active Comparator: Investigator's Choice
    Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W.

Primary Outcome Measure

OS [ Time Frame: Up to approximately 51 months ]

Central Contacts

Locations (29)

FacilityCityStateZIPSite coordinators
City of Hope Cancer Center PhoenixGoodyearArizona85338-
City of Hope National Medical CenterDuarteCalifornia91010-
City of Hope Orange County Lennar Foundation Cancer CenterDuarteCalifornia91010-
Providence Saint Jude Medical CenterFullertonCalifornia92835-
Providence Saint Johns Health CenterSanta MonicaCalifornia90404-
Rocky Mountain Cancer CentersDenverColorado80218-
Medical Oncology Hematology Consultants Helen F Graham Cancer CenterNewarkDelaware19713-
City of Hope AtlantaNewnanGeorgia30265-
University of Illinois ChicagoChicagoIllinois60612-
Midwestern Regional Medical Center dba City of Hope ChicagoZionIllinois60099-
University of Kansas Medical CenterWestwoodKansas66205-
Norton Cancer InstituteLouisvilleKentucky40207-
University of Louisville Health - James Graham Brown Cancer CenterLouisvilleKentucky40202-
Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer CenterBaltimoreMaryland21287-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Barbara Ann Karmanos Cancer InstituteLansingMichigan48910-
Minnesota Oncology Hematology PAMinneapolisMinnesota55404-
University of Minnesota Medical Center FairviewMinneapolisMinnesota55455-
Hematology Oncology Association of Central New YorkEast SyracuseNew York13057-
Oncology Hematology Care IncorporatedCincinnatiOhio45242-
Hightower ClinicalOklahoma CityOklahoma73102-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
United States Oncology Regulatory Affairs Corporate OfficeNashvilleTennessee37203-
The Center for Cancer and Blood DisordersArlingtonTexas76012-
Texas Oncology Northeast TexasTylerTexas75702-
US Oncology Research Investigational Products CenterTylerTexas75702-
University of Virginia Cancer CenterCharlottesvilleVirginia22903-
Virginia Cancer Specialists PCLeesburgVirginia20176-
Virginia Oncology AssociatesNorfolkVirginia23502-

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