RecruitingPhase 3NCT07213674

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

Sponsor

Amgen

Enrollment

750 participants

Start Date

Nov 28, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new combination treatment (xaluritamig plus abiraterone) against standard chemotherapy or hormone therapy for men with advanced prostate cancer that no longer responds to hormone therapy, but who have not yet received chemotherapy for this stage. **You may be eligible if...** - You are 18 or older and have confirmed advanced prostate cancer (called metastatic castration-resistant prostate cancer) - Your cancer has progressed despite hormone-blocking therapy - You have previously tried exactly one hormone receptor blocking drug (enzalutamide, apalutamide, or darolutamide) - Your cancer can be seen on scans and is measurable or progressing - You are reasonably functional (ECOG 0 or 1) - Your organ function is adequate **You may NOT be eligible if...** - You have received prior chemotherapy for your advanced-stage prostate cancer (or more than 6 cycles of docetaxel at an earlier stage) - You have brain metastases - You have previously received a treatment targeting the STEAP1 protein or abiraterone - You have received radioligand therapy recently - You have unresolved serious side effects from prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXaluritamig

Xaluritamig will be administered IV.

DRUGAbiraterone acetate

Abiraterone acetate will be administered orally.

DRUGDocetaxel

Docetaxel will be administered IV.

DRUGCabazitaxel

Cabazitaxel will be administered IV.

Locations(125)

City of Hope Cancer Center Phoenix

Goodyear, Arizona, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Duarte, California, United States

Providence Saint Jude Medical Center

Fullerton, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Newark, Delaware, United States

City of Hope Atlanta

Newnan, Georgia, United States

University of Illinois Chicago

Chicago, Illinois, United States

City of Hope Chicago

Zion, Illinois, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Barbara Ann Karmanos Cancer Institute

Lansing, Michigan, United States

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States

Hematology Oncology Association of Central New York

East Syracuse, New York, United States

Oncology Hematology Care Incorporated

Cincinnati, Ohio, United States

Hightower Clinical

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

The Center for Cancer and Blood Disorders

Arlington, Texas, United States

Texas Oncology Northeast Texas

Tyler, Texas, United States

US Oncology Research Investigational Products Center

Tyler, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Virginia Cancer Specialists PC

Leesburg, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Icon Cancer Care Wesley

Herston, Queensland, Australia

Tasman Oncology Research

Southport, Queensland, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Austin Health, Austin Hospital

East Melbourne, Victoria, Australia

Ordensklinikum Linz Elisabethinen

Linz, Austria

Universitaetsklinikum Sankt Poelten

Sankt Pölten, Austria

Krankenhaus der Barmherzigen Brueder Wien

Vienna, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Austria

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur

Yvoir, Belgium

Sir Mortimer B Davis - Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

Bordeaux, France

Centre Regional Francois Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, France

Centre Leon Berard

Lyon, France

Centre Antoine Lacassagne

Nice, France

Groupe Hospitalier Paris Saint Joseph

Paris, France

Hopital Europeen Georges Pompidou

Paris, France

Hopital Foch

Suresnes, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, Germany

Universitaetsklinikum Bonn

Bonn, Germany

Universitaetsklinikum Dresden

Dresden, Germany

Uniklinikum Erlangen

Erlangen, Germany

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitatsklinikum Jena

Jena, Germany

Universitaetsklinikum Schleswig-Holstein - Kiel

Kiel, Germany

Universitaetsklinikum Ulm

Ulm, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

University General Hospital of Alexandroupoli

Alexandroupoli, Greece

Henry Dunant Hospital Center

Athens, Greece

Alexandra Hospital

Athens, Greece

Attikon University Hospital

Athens, Greece

University Hospital of Heraklion

Heraklion - Crete, Greece

General Oncological Hospital of Kifisia Oi Agioi Anargyroi

Kifissia, Athens, Greece

Athens Medical Center S.A - Iatriko Amarousiou

Marousi, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Italy

Ospedale Pederzoli Casa di Cura Privata

Peschiera del Garda, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

Ospedale Santa Chiara Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento

Trento, Italy

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Kitasato University Hospital

Sagamihara-shi, Kanagawa, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

The University of Osaka Hospital

Suita-shi, Osaka, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Saitama, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya-shi, Saitama, Japan

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

The Cancer institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

The Jikei University Hospital

Minato-ku, Tokyo, Japan

Toyama University Hospital

Toyama, Toyama, Japan

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Hospital da Luz, SA

Lisbon, Portugal

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

Porto, Portugal

Unidade Local de Saude de Gaia-Espinho, EPE

Vila Nova de Gaia, Portugal

National University Hospital

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

A Coruña, Galicia, Spain

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Inselspital Bern

Bern, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Hirslanden Zurich

Zurich, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Guys Hospital

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07213674

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