A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
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
1 other identifier
interventional
750
17 countries
117
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2025
Longer than P75 for phase_3
117 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedStudy Start
First participant enrolled
November 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2032
April 16, 2026
April 1, 2026
4.1 years
September 18, 2025
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OS
Up to approximately 51 months
Secondary Outcomes (36)
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment
Up to approximately 51 months
Objective Response per Modified RECIST 1.1, Per Investigator Assessment
Up to approximately 51 months
Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment
Up to approximately 51 months
Disease Control Per Modified RECIST 1.1, Per Investigator Assessment
Up to approximately 51 months
Progression-free Survival (PFS) 2, Per Investigator Assessment
Up to approximately 51 months
- +31 more secondary outcomes
Study Arms (2)
Xaluritamig Plus Abiraterone
EXPERIMENTALParticipants will be randomized to receive xaluritamig in combination with abiraterone acetate.
Investigator's Choice
ACTIVE COMPARATORParticipants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W.
Interventions
Xaluritamig will be administered IV.
Abiraterone acetate will be administered orally.
Eligibility Criteria
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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (122)
City of Hope Cancer Center Phoenix
Goodyear, Arizona, 85338, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, 91010, United States
Providence Saint Jude Medical Center
Fullerton, California, 92835, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
City of Hope Atlanta
Newnan, Georgia, 30265, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
City of Hope Chicago
Zion, Illinois, 60099, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Hematology Oncology Association of Central New York
East Syracuse, New York, 13057, United States
Oncology Hematology Care Incorporated
Cincinnati, Ohio, 45242, United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
Arlington, Texas, 76012, United States
Texas Oncology Northeast Texas
Tyler, Texas, 75702, United States
US Oncology Research Investigational Products Center
Tyler, Texas, 75702, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22903, United States
Virginia Cancer Specialists PC
Leesburg, Virginia, 20176, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298, Australia
Icon Cancer Care Wesley
Herston, Queensland, 4029, Australia
Tasman Oncology Research
Southport, Queensland, 4215, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health, Austin Hospital
East Melbourne, Victoria, 3002, Australia
Ordensklinikum Linz Elisabethinen
Linz, 4020, Austria
Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100, Austria
Krankenhaus der Barmherzigen Brueder Wien
Vienna, 1020, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur
Yvoir, 5530, Belgium
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux, 33075, France
Centre Regional Francois Baclesse
Caen, 14076, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000, France
Centre Leon Berard
Lyon, 69373, France
Centre Antoine Lacassagne
Nice, 06189, France
Groupe Hospitalier Paris Saint Joseph
Paris, 75014, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hopital Foch
Suresnes, 92151, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94805, France
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, 10117, Germany
Universitaetsklinikum Bonn
Bonn, 53127, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Uniklinikum Erlangen
Erlangen, 91054, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, 24105, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
University General Hospital of Alexandroupoli
Alexandroupoli, 68100, Greece
Henry Dunant Hospital Center
Athens, 11526, Greece
Alexandra Hospital
Athens, 11528, Greece
Attikon University Hospital
Athens, 12462, Greece
University Hospital of Heraklion
Heraklion - Crete, 71500, Greece
General Oncological Hospital of Kifisia Oi Agioi Anargyroi
Kifissia, Athens, 14564, Greece
Athens Medical Center S.A - Iatriko Amarousiou
Marousi, 15125, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, 71122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
Ospedale Pederzoli Casa di Cura Privata
Peschiera del Garda, 37019, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
Ospedale Santa Chiara Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento
Trento, 38122, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
The University of Osaka Hospital
Suita-shi, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, 350-1298, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
The Cancer institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
The Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Toyama University Hospital
Toyama, Toyama, 930-0194, Japan
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, 4200-319, Portugal
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia, 4430-502, Portugal
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, 15006, Spain
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Inselspital Bern
Bern, 3010, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, 9007, Switzerland
Hirslanden Zurich
Zurich, 8032, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
Guys Hospital
London, SE1 9RY, United Kingdom
Sarah Cannon Research Institute UK
London, W1G 6AD, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2025
First Posted
October 9, 2025
Study Start
November 28, 2025
Primary Completion (Estimated)
January 7, 2030
Study Completion (Estimated)
August 30, 2032
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.