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NCT07213674PHASE3Recruiting

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

Amgen

Start Date

11/28/2025

Completion Date

8/30/2032

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: Disease Related: * Participants with a history of central nervous system (CNS) metastases. * Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor. 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.

Interventions

DRUG

Xaluritamig

DRUG

Abiraterone acetate

DRUG

Docetaxel

DRUG

Cabazitaxel

Interested in This Trial?

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Conditions

Metastatic Castration-resistant Prostate Cancer

Locations

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

University of California Irvine

Orange, California 92868

United States

Providence Saint Johns Health Center

Santa Monica, California 90404

United States

Rocky Mountain Cancer Centers

Denver, Colorado 80218

United States

Hartford HealthCare Cancer Institute at Hartford Hospital

Hartford, Connecticut 06102

United States

Medical Oncology Hematology Consultants Helen F Graham Cancer Center

Newark, Delaware 19713

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

City of Hope Atlanta

Newnan, Georgia 30265

United States

University of Illinois Chicago

Chicago, Illinois 60612

United States

Midwestern Regional Medical Center dba City of Hope Chicago

Zion, Illinois 60099

United States

University of Kansas Medical Center

Westwood, Kansas 66205

United States

University of Louisville Health - James Graham Brown Cancer Center

Louisville, Kentucky 40202

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland 21201

United States

Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center

Baltimore, Maryland 21287

United States

Barbara Ann Karmanos Cancer Institute

Lansing, Michigan 48910

United States

Minnesota Oncology Hematology PA

Minneapolis, Minnesota 55404

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

Oregon Oncology Specialists

Salem, Oregon 97301

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15232

United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee 37203

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

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Renovatio Clinical

Houston, Texas 77030

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

Bon Secours Cancer Institute at Saint Francis

Midlothian, Virginia 23114

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

Centre de Recherche du Centre Hospitalier de l Universite de Montreal

Montreal, Quebec H2X 0A9

Canada

Sir Mortimer B Davis - Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

CIUSSS de l Estrie CHUS Hopital Fleurimont

Sherbrooke, Quebec J1H 5N4

Canada

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

Bordeaux, 33075

France

Institut Bergonie

Bordeaux, 33076

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

Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

Strasbourg, 67000

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 di Modena Policlinico

Modena, 41124

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 Sanitaria Universitaria Integrata del Trentino

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

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072

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 Clinic i Provincial de Barcelona

Barcelona, Catalonia 08036

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia 08041

Spain

Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

L'Hospitalet de Llobregat, Catalonia 08908

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 Universitari Vall d Hebron

Barcelona, 08035

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

National Taiwan University Hospital

Taipei, 10002

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