RecruitingPhase 3NCT06691984

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Sponsor

Amgen

Enrollment

675 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

Summary

The main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ARDT\]).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study (XALute) is comparing a new drug called xaluritamig against two standard treatments — cabazitaxel (a chemotherapy) or a second hormone therapy — for men with metastatic castration-resistant prostate cancer (mCRPC), meaning their cancer has spread and continues to grow despite hormone-blocking treatment. Xaluritamig is a targeted therapy designed to attack a protein called STEAP1 found on prostate cancer cells. **You may be eligible if...** - You are male, 18 or older - You have confirmed metastatic castration-resistant prostate cancer - Your PSA (prostate-specific antigen) is rising or your cancer is growing despite standard hormone treatments - You have at least one measurable metastatic lesion on scans - You have previously been treated with one or more standard therapies for prostate cancer **You may NOT be eligible if...** - Your cancer has small cell or neuroendocrine features - You have untreated or unstable brain metastases - You have serious heart, liver, or other organ problems - You have had recent major surgery or radiation - You are unwilling to use contraception 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

Short-term IV infusion

DRUGAbiraterone

Oral tablets

DRUGEnzalutamide

Oral tablets

DRUGCabazitaxel

IV infusion

Locations(164)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

Providence Saint Jude Medical Center

Fullerton, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

University of California San Francisco

San Francisco, California, United States

University of Florida, College of Medicine

Gainesville, Florida, United States

Sylvester Comprehensive Cancer Center-Fox Building

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Louisville Health - James Graham Brown Cancer Center

Louisville, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Hospital, Henry Ford Health Systems

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Yale New Haven Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Macquarie University

North Ryde, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Medical Centre

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medizinische Universitaet Graz

Graz, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Landeskrankenhaus Salzburg

Salzburg, 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

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B Davis - Jewish General Hospital

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval

Québec, Quebec, Canada

Aarhus University Hospital

Aarhus N, Denmark

Vejle Sygehus

Vejle, Denmark

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

Bordeaux, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

La Tronche, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, France

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Hopital d Instruction des Armees - Hopital Begin

Saint-Mandé, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, Germany

Universitaetsklinikum Dresden

Dresden, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, Germany

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Jena

Jena, Germany

Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, Germany

Klinikum rechts der Isar der TUM

München, Germany

Universitaetsklinikum Muenster

Münster, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Alexandra Hospital

Athens, Greece

Athens Medical Center S.A - Iatriko Amarousiou

Athens, Greece

Metropolitan General

Athens, Greece

Metropolitan Hospital

Athens, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, Italy

Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce

Gallipoli, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Italy

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

Trento, Italy

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Kitasato University Hospital

Sagamihara-shi, Kanagawa, Japan

Yokohama City University Medical Center

Yokohama, 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

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

Reinier de Graaf Gasthuis

Delft, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, Poland

National University Hospital

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Chungnam National University Hospital

Daejeon, South Korea

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Regional Universitario de Malaga

Málaga, Andalusia, Spain

Hospital Universitario Virgen del Rocio

Seville, 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

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Instituto Valenciano de Oncologia

Valencia, Valencia, Spain

Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Skanes Universitetssjukhus

Lund, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

Norrlands Universitetssjukhus

Umeå, Sweden

Istituto Oncologico della Svizzera Italiana

Bellinzona, Switzerland

Inselspital Bern

Bern, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan, Taiwan

Ankara Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, Turkey (Türkiye)

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

University College London Hospital

London, United Kingdom

Guys Hospital

London, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

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