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RECRUITING
NCT07213674
PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2025-11-28

Completion Date

2032-08-30

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Xaluritamig

Xaluritamig will be administered IV.

DRUG

Abiraterone acetate

Abiraterone acetate will be administered orally.

DRUG

Docetaxel

Docetaxel will be administered IV.

DRUG

Cabazitaxel

Cabazitaxel will be administered IV.

Locations (120)

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

Norton Cancer Institute

Louisville, Kentucky, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 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

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

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

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