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A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Sponsor: Amgen
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
Xaluritamig
Xaluritamig will be administered IV.
Abiraterone acetate
Abiraterone acetate will be administered orally.
Docetaxel
Docetaxel will be administered IV.
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