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New hope for tough prostate cancer: xaluritamig takes on standard therapy in major trial

NCT ID NCT06691984

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new drug called xaluritamig helps people with advanced prostate cancer live longer compared to usual treatments (cabazitaxel or another hormone therapy). The trial includes about 700 adults whose cancer has spread and no longer responds to hormone therapy after chemotherapy. The main goal is to see if xaluritamig improves overall survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

707 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has provided informed consent prior to 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. * 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 prior to enrollment. * Evidence of progressive disease, defined as 1 or more PCWG3 criteria: * Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal 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 one 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 lesion(s) by bone scan (as per the 2+2 PCWG3 criteria). * Participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior progression on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide). * Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. * Adequate organ function. * Life expectancy of ≥ 12 weeks per the treating physician's assessment. Key Exclusion Criteria: Prior \& Concomitant Therapy: * Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. * Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen receptor pathway inhibitors (ARPIs) (abiraterone, enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment and androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]). * Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of study treatment unless participants received \< 2 cycles of therapy. * Prior palliative radiotherapy within 2 weeks of first dose of study treatment. Participants must have recovered from all radiation-related toxicities. * Concurrent cytotoxic chemotherapy, ARDT, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy. Note: Prior treatment with a PARP inhibitor is permitted as long as not within 4 weeks before first dose of study treatment. * Prior radionuclide therapy (Radium-223) within 2 months of first dose of study treatment. * Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment. Disease Related: * Participants with a history of central nervous system (CNS) metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible. * Unresolved toxicities from prior anti-tumor therapy not having resolved to CTCAE version 5.0 events grade above 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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma neoplasm prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Alexandra Hospital

    Athens, 11528, Greece

  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

    Kortrijk, 8500, Belgium

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 06620, Turkey (Türkiye)

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Athens Medical Center S.A - Iatriko Amarousiou

    Athens, 15125, Greece

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano, 10043, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71122, Italy

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU de Quebec-Universite Laval

    Québec, Quebec, G1R 2J6, Canada

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

    Bordeaux, 33075, France

  • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

    La Tronche, 38700, France

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000, Belgium

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117, Germany

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72000, France

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya-shi, Saitama, 343-8555, Japan

  • Duke University Medical Center Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98019-1024, United States

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511, Japan

  • Gustave Roussy

    Villejuif, 94805, France

  • Guys Hospital

    London, SE1 9RY, United Kingdom

  • Henry Ford Hospital, Henry Ford Health Systems

    Detroit, Michigan, 48202, United States

  • Hopital d Instruction des Armees - Hopital Begin

    Saint-Mandé, 94163, France

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29011, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • Instituto Valenciano de Oncologia

    Valencia, Valencia, 46009, Spain

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500, Switzerland

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575, Turkey (Türkiye)

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kantonsspital Graubuenden

    Chur, 7000, Switzerland

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007, Switzerland

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76, Sweden

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0375, Japan

  • Klinikum rechts der Isar der TUM

    München, 81675, Germany

  • Krankenhaus der Barmherzigen Brueder Wien

    Vienna, 1020, Austria

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305, Taiwan

  • Macquarie University

    North Ryde, New South Wales, 2109, Australia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020, Austria

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Metropolitan General

    Athens, 15562, Greece

  • Metropolitan Hospital

    Athens, 18547, Greece

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Norrlands Universitetssjukhus

    Umeå, 901 85, Sweden

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Ordensklinikum Linz Elisabethinen

    Linz, 4010, Austria

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132, Italy

  • Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce

    Gallipoli, 73014, Italy

  • Ospedale Santa Chiara Azienda Sanitaria Universitaria Integrata del Trentino

    Trento, 38122, Italy

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5, Canada

  • Providence Saint Jude Medical Center

    Fullerton, California, 92835, United States

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong, Hong Kong

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD, Netherlands

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501, Poland

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45, Sweden

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama, 350-1298, Japan

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Sir Mortimer B Davis - Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Skanes Universitetssjukhus

    Lund, 221 85, Sweden

  • Swedish Medical Center

    Seattle, Washington, 98104, United States

  • Sylvester Comprehensive Cancer Center-Fox Building

    Miami, Florida, 33136, United States

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203, United States

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Cancer institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Osaka Hospital

    Suita-shi, Osaka, 565-0871, Japan

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090, Austria

  • Universitaetsklinikum Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Jena

    Jena, 07747, Germany

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitaetsklinikum Sankt Poelten

    Sankt Pölten, 3100, Austria

  • Universitaetsklinikum Schleswig-Holstein - Luebeck

    Lübeck, 23538, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • University College London Hospital

    London, NW1 2PG, United Kingdom

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Irvine

    Orange, California, 92868, United States

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Florida, College of Medicine

    Gainesville, Florida, 32610, United States

  • University of Louisville Health - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Vejle Sygehus

    Vejle, 7100, Denmark

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Yale New Haven Hospital

    New York, New York, 10032, United States

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

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