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
2 other identifiers
interventional
707
21 countries
158
Brief 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 \[ARDT\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2024
Longer than P75 for phase_3
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2024
CompletedFirst Posted
Study publicly available on registry
November 18, 2024
CompletedStudy Start
First participant enrolled
December 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2029
May 15, 2026
May 1, 2026
4.1 years
November 14, 2024
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Up to approximately 53 months
Secondary Outcomes (31)
Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Up to approximately 53 months
Objective Response Rate per Modified RECIST v1.1 as Assessed by BICR
Up to approximately 53 months
Duration of Response (DOR) per Modified RECIST v1.1 as Assessed by BICR
Up to approximately 53 months
Disease Control Rate per Modified RECIST v1.1 as Assessed by BICR
Up to approximately 53 months
Time to Response (TTR) per Modified RECIST v1.1 as Assessed by BICR
Up to approximately 53 months
- +26 more secondary outcomes
Study Arms (2)
Xaluritamig
EXPERIMENTALParticipants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion.
Cabazitaxel/Abiraterone/Enzalutamide
ACTIVE COMPARATORParticipants with mCRPC will be randomized to receive cabazitaxel as an IV infusion, or a second androgen receptor-directed therapy of either abiraterone as oral tablets, or enzalutamide as oral tablets at the investigator's discretion.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (164)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Providence Saint Jude Medical Center
Fullerton, California, 92835, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Irvine
Orange, California, 92868, United States
University of California San Francisco
San Francisco, California, 94158, United States
University of Florida, College of Medicine
Gainesville, Florida, 32610, United States
Sylvester Comprehensive Cancer Center-Fox Building
Miami, Florida, 33136, United States
AdventHealth Orlando
Orlando, Florida, 32804, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Louisville Health - James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Henry Ford Hospital, Henry Ford Health Systems
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63110, United States
Yale New Haven Hospital
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Duke University Medical Center Duke Cancer Center
Durham, North Carolina, 27710, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, 57104, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98019-1024, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050, Australia
Macquarie University
North Ryde, New South Wales, 2109, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Ordensklinikum Linz Elisabethinen
Linz, 4010, Austria
Landeskrankenhaus Salzburg
Salzburg, 5020, 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
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, 8500, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5, Canada
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CHU de Quebec-Universite Laval
Québec, Quebec, G1R 2J6, Canada
Aarhus University Hospital
Aarhus N, 8200, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux, 33075, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
La Tronche, 38700, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
Institut Paoli Calmettes
Marseille, 13009, France
Centre Antoine Lacassagne
Nice, 06189, France
Hopital d Instruction des Armees - Hopital Begin
Saint-Mandé, 94163, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94805, France
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, 10117, Germany
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 Schleswig-Holstein - Luebeck
Lübeck, 23538, Germany
Klinikum rechts der Isar der TUM
München, 81675, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97078, Germany
Alexandra Hospital
Athens, 11528, Greece
Athens Medical Center S.A - Iatriko Amarousiou
Athens, 15125, Greece
Metropolitan General
Athens, 15562, Greece
Metropolitan Hospital
Athens, 18547, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, 71122, Italy
Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce
Gallipoli, 73014, Italy
Ospedale Policlinico San Martino IRCCS
Genova, 16132, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, 10043, Italy
Ospedale Santa Chiara Azienda Sanitaria Universitaria Integrata del Trentino
Trento, 38122, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, 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
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, 1066 CX, Netherlands
Reinier de Graaf Gasthuis
Delft, 2625 AD, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501, Poland
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Chungnam National University Hospital
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
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
Asan Medical Center
Seoul, 05505, South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Instituto Valenciano de Oncologia
Valencia, Valencia, 46009, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Skanes Universitetssjukhus
Lund, 221 85, Sweden
Karolinska Universitetssjukhuset
Stockholm, 171 76, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Kantonsspital Graubuenden
Chur, 7000, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, 9007, 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
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305, Taiwan
Ankara Universitesi Tip Fakultesi Hastanesi
Ankara, 06620, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575, Turkey (Türkiye)
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
University College London Hospital
London, NW1 2PG, United Kingdom
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2024
First Posted
November 18, 2024
Study Start
December 9, 2024
Primary Completion (Estimated)
January 2, 2029
Study Completion (Estimated)
July 30, 2029
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.