Metastatic Castration-resistant Prostate CancerPhase 3NCT07213674
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
A Phase 3 study testing Xaluritamig, Abiraterone acetate and Docetaxel in people with Metastatic Castration-resistant Prostate Cancer, run by Amgen at 159 sites in 18 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Xaluritamig, Abiraterone acetate and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 159 sitesin 18 countries
- Study dates
- 28 Nov 2025to 30 Aug 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
159 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
159 sites in 18 countries
United States46 sites, 45 recruiting
- Recruiting
The Center for Cancer and Blood Disorders
Arlington, Texas, 76012
- Recruiting
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
- Recruiting
Johns Hopkins Hospital Sidney Kimmell Comprehensive Cancer Center
Baltimore, Maryland, 21287
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
- Recruiting
Oncology Hematology Care Incorporated
Cincinnati, Ohio, 45242
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Dayton Physicians LLC Dayton
Dayton, Ohio, 45415
- Recruiting
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526
- Recruiting
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
- Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, 91010
- Recruiting
Hematology Oncology Association of Central New York
East Syracuse, New York, 13057
- Recruiting
Providence Saint Jude Medical Center
Fullerton, California, 92835
- Recruiting
City of Hope Cancer Center Phoenix
Goodyear, Arizona, 85338
- Recruiting
Hartford HealthCare Cancer Institute at Hartford Hospital
Hartford, Connecticut, 06102
- Recruiting
Renovatio Clinical
Houston, Texas, 77030
- Recruiting
Barbara Ann Karmanos Cancer Institute
Lansing, Michigan, 48910
- Recruiting
Virginia Cancer Specialists PC
Leesburg, Virginia, 20176
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
- Recruiting
University of Louisville Health - James Graham Brown Cancer Center
Louisville, Kentucky, 40202
- Terminated
Norton Cancer Institute
Louisville, Kentucky, 40207
- Recruiting
Bon Secours Cancer Institute at Saint Francis
Midlothian, Virginia, 23114
- Recruiting
Minnesota Oncology Hematology PA
Minneapolis, Minnesota, 55404
- Recruiting
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
- Recruiting
South Texas Accelerated Research Therapeutics - Carolinas
Myrtle Beach, South Carolina, 29572
- Recruiting
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713
- Recruiting
City of Hope Atlanta
Newnan, Georgia, 30265
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
- Recruiting
Hightower Clinical
Oklahoma City, Oklahoma, 73102
- Recruiting
University of California Irvine
Orange, California, 92868
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Oregon Oncology Specialists
Salem, Oregon, 97301
- Recruiting
University of California San Francisco
San Francisco, California, 94158
- Recruiting
Providence Saint Johns Health Center
Santa Monica, California, 90404
- Recruiting
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85724
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
- Recruiting
US Oncology Research Investigational Products Center
Tyler, Texas, 75702
- Recruiting
University of Kansas Medical Center
Westwood, Kansas, 66205
- Recruiting
Midwestern Regional Medical Center dba City of Hope Chicago
Zion, Illinois, 60099
Japan15 sites, 13 recruiting
- Recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
- Terminated
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, 350-1298
- Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
- Recruiting
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
- Recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
- Terminated
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, 343-8555
- Recruiting
The Cancer institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
- Recruiting
The Jikei University Hospital
Minato-ku, Tokyo, 105-8471
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
- Recruiting
Kitasato University Hospital
Sagamihara-shi, Kanagawa, 252-0375
- Recruiting
The University of Osaka Hospital
Suita-shi, Osaka, 565-0871
- Recruiting
Toyama University Hospital
Toyama, Toyama, 930-0194
France14 sites, 14 recruiting
- Recruiting
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
Bordeaux, 33075
- Recruiting
Institut Bergonie
Bordeaux, 33076
- Recruiting
Centre Regional Francois Baclesse
Caen, 14076
- Recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
- Recruiting
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72000
- Recruiting
Centre Leon Berard
Lyon, 69373
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
- Recruiting
Groupe Hospitalier Paris Saint Joseph
Paris, 75014
- Recruiting
Hopital Europeen Georges Pompidou
Paris, 75015
- Recruiting
Centre Hospitalier Universitaire de Strasbourg - Hopital de Hautepierre
Strasbourg, 67000
- Recruiting
Hopital Foch
Suresnes, 92151
- Recruiting
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
- Recruiting
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
- Recruiting
Gustave Roussy
Villejuif, 94805
Spain13 sites, 13 recruiting
- Recruiting
Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
A Coruña, Galicia, 15006
- Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
- Recruiting
Hospital Universitari Vall d Hebron
Barcelona, 08035
- Recruiting
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
- Recruiting
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Germany11 sites, 11 recruiting
- Recruiting
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, 10117
- Recruiting
Universitaetsklinikum Bonn
Bonn, 53127
- Recruiting
Universitaetsklinikum Dresden
Dresden, 01307
- Recruiting
Uniklinikum Erlangen
Erlangen, 91054
- Recruiting
Universitaetsklinikum Essen
Essen, 45147
- Recruiting
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
- Recruiting
Universitaetsklinikum Heidelberg
Heidelberg, 69120
- Recruiting
Universitaetsklinikum Jena
Jena, 07747
- Recruiting
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, 24105
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97080
Greece8 sites, 7 recruiting
- Recruiting
University General Hospital of Alexandroupoli
Alexandroupoli, 68100
- Recruiting
Henry Dunant Hospital Center
Athens, 11526
- Recruiting
Alexandra Hospital
Athens, 11528
- Recruiting
Attikon University Hospital
Athens, 12462
- Recruiting
University Hospital of Heraklion
Heraklion - Crete, 71500
- Terminated
General Oncological Hospital of Kifisia Oi Agioi Anargyroi
Kifissia, Athens, 14564
- Recruiting
Athens Medical Center S.A - Iatriko Amarousiou
Marousi, 15125
- Recruiting
European Interbalkan Medical Center
Thessaloniki, 57001
Italy8 sites, 8 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
Foggia, 71122
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
- Recruiting
Azienda Ospedaliera Universitaria di Modena Policlinico
Modena, 41124
- Recruiting
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, 10043
- Recruiting
Ospedale Pederzoli Casa di Cura Privata
Peschiera del Garda, 37019
- Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
- Recruiting
Ospedale Santa Chiara Azienda Sanitaria Universitaria Integrata del Trentino
Trento, 38122
Australia6 sites, 5 recruiting
- Recruiting
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
Austin Health, Austin Hospital
East Melbourne, Victoria, 3002
- Terminated
Tasman Oncology Research
Southport, Queensland, 4215
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Austria5 sites, 5 recruiting
- Recruiting
Medizinische Universitaet Innsbruck
Innsbruck, 6020
- Recruiting
Ordensklinikum Linz Elisabethinen
Linz, 4020
- Recruiting
Universitaetsklinikum Sankt Poelten
Sankt Pölten, 3100
- Recruiting
Krankenhaus der Barmherzigen Brueder Wien
Vienna, 1020
- Recruiting
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090
Belgium5 sites, 5 recruiting
- Recruiting
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
Kortrijk, 8500
- Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
- Recruiting
Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur
Yvoir, 5530
Portugal5 sites, 5 recruiting
- Recruiting
Hospital da Luz, SA
Lisbon, 1500-650
- Recruiting
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035
- Recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072
- Recruiting
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
Porto, 4200-319
- Recruiting
Unidade Local de Saude de Gaia-Espinho, EPE
Vila Nova de Gaia, 4430-502
Canada4 sites, 4 recruiting
- Recruiting
Centre de Recherche du Centre Hospitalier de l Universite de Montreal
Montreal, Quebec, H2X 0A9
- Recruiting
Sir Mortimer B Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
CIUSSS de l Estrie CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
- Recruiting
Sunnybrook Research Institute Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
Switzerland4 sites, 4 recruiting
- Recruiting
Inselspital Bern
Bern, 3010
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
- Recruiting
Kantonsspital Sankt Gallen
Sankt Gallen, 9007
- Recruiting
Hirslanden Zurich
Zurich, 8032
Taiwan4 sites, 4 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Singapore3 sites, 3 recruiting
- Recruiting
National University Hospital
Singapore, 119074
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
United Kingdom3 sites, 3 recruiting
- Recruiting
Guys Hospital
London, SE1 9RY
- Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
- Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
Netherlands1 site, 1 recruiting
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
About this study
Official title: A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
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).
- Being tested
- Xaluritamig, Abiraterone acetate, Docetaxel, Cabazitaxel
- Keywords
- Prostate Cancer, Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer, Xaluritamig, Abiraterone, Abiraterone Acetate, Docetaxel, Cabazitaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XaluritamigDrug
Also called AMG 509
Xaluritamig will be administered IV.
Abiraterone acetateDrug
Abiraterone acetate will be administered orally.
DocetaxelDrug
Docetaxel will be administered IV.
CabazitaxelDrug
Cabazitaxel will be administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Xaluritamig Plus Abiraterone | Experimental | Participants will be randomized to receive xaluritamig in combination with abiraterone acetate. Receives: Drug: Xaluritamig; Drug: Abiraterone acetate |
| Investigator's Choice | Active comparator | Participants will receive investigator's choice of:
* Abiraterone acetate orally, once daily or
* Docetaxel IV Q3W or
* Cabazitaxel IV Q3W. Receives: Drug: Abiraterone acetate; Drug: Docetaxel; Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Measured: Up to approximately 51 months
Secondary outcomes (36)
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Per Investigator Assessment
Measured: Up to approximately 51 months
Objective Response per Modified RECIST 1.1, Per Investigator Assessment
Measured: Up to approximately 51 months
Duration of Response (DOR) Per Modified RECIST 1.1, Per Investigator Assessment
Measured: Up to approximately 51 months
Disease Control Per Modified RECIST 1.1, Per Investigator Assessment
Measured: Up to approximately 51 months
Progression-free Survival (PFS) 2, Per Investigator Assessment
Measured: Up to approximately 51 months
Time to Response (TTR), Per Modified RECIST 1.1, Per Investigator Assessment
Measured: Up to approximately 51 months
Time to First Subsequent Therapy
Measured: Up to approximately 51 months
Time to Symptomatic Skeletal Events (SSE)
Measured: Up to approximately 51 months
Number of Participants With Treatment-emergent Adverse events, Treatment-emergent Serious Adverse Events, and Fatal Adverse Events
Measured: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in Brief Pain Inventory - Short Form (BPI-SF) Pain Intensity Scale
Measured: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in BPI-SF Worst Pain Score
Measured: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in BPI-SF Pain Interference Scale
Measured: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Scores
Measured: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in European Quality of Life (EuroQol) 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score
Measured: Up to approximately 51 months
Change From Baseline Over Time at Each Assessment in the EQ-5D-5L Visual Analogue Scale (VAS)
Measured: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Worst Pain Score
Measured: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Pain Intensity Scale
Measured: Up to approximately 51 months
Time to Worsening as Measured by BPI-SF Pain Interference Scale
Measured: Up to approximately 51 months
Time to Worsening as Measured by FACT-P Total Score
Measured: Up to approximately 51 months
Time to Improvement as Measured by BPI-SF Worst Pain Score in Participants with Moderate/Severe Pain at Baseline
Measured: Up to approximately 51 months
Time to Improvement After Worsening as Measured by BPI-SF Pain Intensity Scale Score
Measured: Up to approximately 51 months
Time to Improvement After Worsening as Measured by BPI-SF Pain Interference Scale Score
Measured: Up to approximately 51 months
Summary Scores Over Time at Each Assessment as Measured by Selected Questions on Symptomatic Adverse Events from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library
Measured: Up to approximately 51 months
Summary Scores Over Time at Each Assessment as Measured by the GP5 Question on Overall Bother of Side Effects from the FACT-P Questionnaire
Measured: Up to approximately 51 months
Prostate-specific Antigen (PSA) 50 and PSA 90 Responses
Measured: Up to approximately 51 months
Time to PSA 50 and PSA 90 Response
Measured: Up to approximately 51 months
Duration of PSA 50 and PSA 90 Response
Measured: Up to approximately 51 months
Time to PSA Progression
Measured: Up to approximately 51 months
Maximum Serum Concentration (Cmax) of Xaluritamig
Measured: Up to approximately 51 months
Time to Maximum Concentration (Tmax) of Xaluritamig
Measured: Up to approximately 51 months
Minimum Serum Concentration (Cmin) of Xaluritamig
Measured: Up to approximately 51 months
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Xaluritamig
Measured: Up to approximately 51 months
Accumulation Ratio of the AUC Over the Dosing Interval for Xaluritamig
Measured: Up to approximately 51 months
Half-life (t1/2) of Xaluritamig
Measured: Up to approximately 51 months
Abiraterone Serum Concentrations
Measured: Up to approximately 51 months
Number of Participants with Formation of Anti-xaluritamig Antibodies
Measured: Up to approximately 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start28 Nov 2025
- Primary completion7 Jan 2030 (estimated)
- Study completion30 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213674
- Sponsor's protocol ID
- 20230239
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.