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New hope for men with Hard-to-Treat prostate cancer: drug combo trial launches

NCT ID NCT07213674

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 9 times

Summary

This phase 3 trial is testing whether adding the experimental drug xaluritamig to standard abiraterone helps men with metastatic castration-resistant prostate cancer live longer. About 750 participants who have not yet had chemotherapy will be randomly assigned to receive either the combination or one of several standard treatments. The main goal is to compare overall survival between the groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xaluritamig (also called AMG 509) plus abiraterone
What this could lead to
If successful, this combination could extend survival for men with advanced prostate cancer that no longer responds to hormone therapy, offering a new treatment option before chemotherapy.
What could go wrong
This is a large phase 3 trial, but the experimental drug is still investigational. It may not improve survival compared to current treatments, and side effects from the combination could be significant.

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

About 750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Aug 2032

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 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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Metastatic castration resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    154 sites in 18 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alexandra Hospital

    RECRUITING

    Athens, 11528, Greece

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Athens Medical Center S.A - Iatriko Amarousiou

    RECRUITING

    Marousi, 15125, Greece

  • Attikon University Hospital

    RECRUITING

    Athens, 12462, Greece

  • Austin Health, Austin Hospital

    RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    RECRUITING

    Orbassano, 10043, Italy

  • Azienda Ospedaliera Universitaria di Modena Policlinico

    RECRUITING

    Modena, 41124, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    RECRUITING

    Foggia, 71122, Italy

  • Barbara Ann Karmanos Cancer Institute

    RECRUITING

    Lansing, Michigan, 48910, United States

  • Bon Secours Cancer Institute at Saint Francis

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • CIUSSS de l Estrie CHUS Hopital Fleurimont

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Calvary Mater Newcastle Hospital

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Cancer Care Specialists of Illinois

    RECRUITING

    Decatur, Illinois, 62526, United States

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur

    RECRUITING

    Yvoir, 5530, Belgium

  • Centre Hospitalier Universitaire Vaudois

    RECRUITING

    Lausanne, 1011, Switzerland

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

    RECRUITING

    Bordeaux, 33075, France

  • Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre

    RECRUITING

    Strasbourg, 67000, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Centre Regional Francois Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre de Recherche du Centre Hospitalier de l Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    RECRUITING

    Berlin, 10117, Germany

  • City of Hope Atlanta

    RECRUITING

    Newnan, Georgia, 30265, United States

  • City of Hope Cancer Center Phoenix

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Clinique Victor Hugo - Centre Jean Bernard

    RECRUITING

    Le Mans, 72000, France

  • Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

    RECRUITING

    A Coruña, Galicia, 15006, Spain

  • Dayton Physicians LLC Dayton

    RECRUITING

    Dayton, Ohio, 45415, United States

  • Dokkyo Medical University Saitama Medical Center

    RECRUITING

    Koshigaya-shi, Saitama, 343-8555, Japan

  • European Interbalkan Medical Center

    RECRUITING

    Thessaloniki, 57001, Greece

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • General Oncological Hospital of Kifisia Oi Agioi Anargyroi

    RECRUITING

    Kifissia, Athens, 14564, Greece

  • Groupe Hospitalier Paris Saint Joseph

    RECRUITING

    Paris, 75014, France

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Guys Hospital

    RECRUITING

    London, SE1 9RY, United Kingdom

  • Hartford HealthCare Cancer Institute at Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Hematology Oncology Association of Central New York

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Henry Dunant Hospital Center

    RECRUITING

    Athens, 11526, Greece

  • Hightower Clinical

    RECRUITING

    Oklahoma City, Oklahoma, 73102, United States

  • Hirslanden Zurich

    RECRUITING

    Zurich, 8032, Switzerland

  • Hopital Europeen Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • Hopital Foch

    RECRUITING

    Suresnes, 92151, France

  • Hospital Clinic i Provincial de Barcelona

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Clinico Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, Andalusia, 29011, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, Galicia, 27003, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital da Luz, SA

    RECRUITING

    Lisbon, 1500-650, Portugal

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalonia, 08041, Spain

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Icon Cancer Care Wesley

    RECRUITING

    Auchenflower, Queensland, 4066, Australia

  • Inselspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Institut Bergonie

    RECRUITING

    Bordeaux, 33076, France

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, Catalonia, 08908, Spain

  • Institut Universitaire du Cancer Toulouse Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Institut de Cancerologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    RECRUITING

    Porto, 4200-072, Portugal

  • Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kagawa University Hospital

    RECRUITING

    Kita-gun, Kagawa-ken, 761-0793, Japan

  • Kanazawa University Hospital

    RECRUITING

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kantonsspital Sankt Gallen

    RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Kitasato University Hospital

    RECRUITING

    Sagamihara-shi, Kanagawa, 252-0375, Japan

  • Kobe University Hospital

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • Krankenhaus der Barmherzigen Brueder Wien

    RECRUITING

    Vienna, 1020, Austria

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, Fukuoka, 812-8582, Japan

  • Medical Oncology Hematology Consultants Helen F Graham Cancer Center

    RECRUITING

    Newark, Delaware, 19713, United States

  • Medizinische Universitaet Innsbruck

    RECRUITING

    Innsbruck, 6020, Austria

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Midwestern Regional Medical Center dba City of Hope Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • Minnesota Oncology Hematology PA

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Centre Singapore

    RECRUITING

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 70403, Taiwan

  • National Hospital Organization Shikoku Cancer Center

    RECRUITING

    Matsuyama, Ehime, 791-0280, Japan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • National University Hospital

    RECRUITING

    Singapore, 119074, Singapore

  • Nippon Medical School Hospital

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Northwest Medical Specialties, PLLC

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Oncology Hematology Care Incorporated

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Ordensklinikum Linz Elisabethinen

    RECRUITING

    Linz, 4020, Austria

  • Oregon Oncology Specialists

    RECRUITING

    Salem, Oregon, 97301, United States

  • Osaka International Cancer Institute

    RECRUITING

    Osaka, Osaka, 541-8567, Japan

  • Ospedale Pederzoli Casa di Cura Privata

    RECRUITING

    Peschiera del Garda, 37019, Italy

  • Ospedale Santa Chiara Azienda Sanitaria Universitaria Integrata del Trentino

    RECRUITING

    Trento, 38122, Italy

  • Providence Saint Johns Health Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • Providence Saint Jude Medical Center

    RECRUITING

    Fullerton, California, 92835, United States

  • Renovatio Clinical

    RECRUITING

    Houston, Texas, 77030, United States

  • Rocky Mountain Cancer Centers

    RECRUITING

    Denver, Colorado, 80218, United States

  • Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Saitama Medical University International Medical Center

    TERMINATED

    Hidaka-shi, Saitama, 350-1298, Japan

  • Sarah Cannon Research Institute Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Sir Mortimer B Davis - Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • South Texas Accelerated Research Therapeutics - Carolinas

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Sunnybrook Research Institute Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Tan Tock Seng Hospital

    RECRUITING

    Singapore, 308433, Singapore

  • Tasman Oncology Research

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Texas Oncology - Northeast Texas

    RECRUITING

    Tyler, Texas, 75702, United States

  • The Cancer institute Hospital of Japanese Foundation for Cancer Research

    RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The Center for Cancer and Blood Disorders

    RECRUITING

    Arlington, Texas, 76012, United States

  • The Jikei University Hospital

    RECRUITING

    Minato-ku, Tokyo, 105-8471, Japan

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Osaka Hospital

    RECRUITING

    Suita-shi, Osaka, 565-0871, Japan

  • Toyama University Hospital

    RECRUITING

    Toyama, Toyama, 930-0194, Japan

  • US Oncology Research Investigational Products Center

    RECRUITING

    Tyler, Texas, 75702, United States

  • Unidade Local de Saude de Gaia-Espinho, EPE

    RECRUITING

    Vila Nova de Gaia, 4430-502, Portugal

  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

    RECRUITING

    Porto, 4200-319, Portugal

  • Uniklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • United States Oncology Regulatory Affairs Corporate Office

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    RECRUITING

    Vienna, 1090, Austria

  • Universitaetsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitaetsklinikum Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • Universitaetsklinikum Sankt Poelten

    RECRUITING

    Sankt Pölten, 3100, Austria

  • Universitaetsklinikum Schleswig-Holstein - Kiel

    RECRUITING

    Kiel, 24105, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, 97080, Germany

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    RECRUITING

    Brussels, 1200, Belgium

  • University General Hospital of Alexandroupoli

    RECRUITING

    Alexandroupoli, 68100, Greece

  • University Hospital of Heraklion

    RECRUITING

    Heraklion - Crete, 71500, Greece

  • University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85724, United States

  • University of California Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Kansas Medical Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Louisville Health - James Graham Brown Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Maryland Greenebaum Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Minnesota Medical Center Fairview

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Virginia Cancer Specialists PC

    RECRUITING

    Leesburg, Virginia, 20176, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

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