AzTrials
AzTrials

Metastatic Castration-resistant Prostate CancerPhase 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 study testing Xaluritamig, Abiraterone and Enzalutamide in people with Metastatic Castration-resistant Prostate Cancer, run by Amgen at 164 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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]). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Xaluritamig, Abiraterone and Enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
707 participants
Where
164 sitesin 22 countries
Study dates
9 Dec 2024to 30 Jul 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

164 sites in 22 countries.

164 sites in 22 countries

United States42 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Hospital, Henry Ford Health Systems

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University Medical Center Duke Cancer Center

    Durham, North Carolina, 27710

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Providence Saint Jude Medical Center

    Fullerton, California, 92835

  • University of Florida, College of Medicine

    Gainesville, Florida, 32610

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville Health - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53705

  • Sylvester Comprehensive Cancer Center-Fox Building

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • University of California Irvine

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • University of California San Francisco

    San Francisco, California, 94158

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98019-1024

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota, 57104

  • Washington University

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Japan15 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama, 350-1298

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya-shi, Saitama, 343-8555

  • The Cancer institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0375

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • The University of Osaka Hospital

    Suita-shi, Osaka, 565-0871

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

France11 sites

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre

    Bordeaux, 33075

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

    La Tronche, 38700

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72000

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, 13009

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital d Instruction des Armees - Hopital Begin

    Saint-Mandé, 94163

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany11 sites

  • Charite - Universitaetsmedizin Berlin, Campus Mitte

    Berlin, 10117

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Jena

    Jena, 07747

  • Universitaetsklinikum Schleswig-Holstein - Luebeck

    Lübeck, 23538

  • Klinikum rechts der Isar der TUM

    München, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Spain10 sites

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29011

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Instituto Valenciano de Oncologia

    Valencia, Valencia, 46009

Other trials in Spain

Austria7 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Ordensklinikum Linz Elisabethinen

    Linz, 4010

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Universitaetsklinikum Sankt Poelten

    Sankt Pölten, 3100

  • Krankenhaus der Barmherzigen Brueder Wien

    Vienna, 1020

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Italy7 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71122

  • Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce

    Gallipoli, 73014

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Ospedale Santa Chiara Azienda Sanitaria Universitaria Integrata del Trentino

    Trento, 38122

Other trials in Italy

Australia6 sites

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Macquarie University

    North Ryde, New South Wales, 2109

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea6 sites

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Canada5 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Sir Mortimer B Davis - Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • CHU de Quebec-Universite Laval

    Québec, Quebec, G1R 2J6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Greece5 sites

  • Alexandra Hospital

    Athens, 11528

  • Athens Medical Center S.A - Iatriko Amarousiou

    Athens, 15125

  • Metropolitan General

    Athens, 15562

  • Metropolitan Hospital

    Athens, 18547

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Netherlands5 sites

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

Other trials in Netherlands

Switzerland5 sites

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

  • Inselspital Bern

    Bern, 3010

  • Kantonsspital Graubuenden

    Chur, 7000

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305

Other trials in Taiwan

United Kingdom5 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University College London Hospital

    London, NW1 2PG

  • Guys Hospital

    London, SE1 9RY

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium4 sites

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

    Kortrijk, 8500

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

Other trials in Belgium

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Skanes Universitetssjukhus

    Lund, 221 85

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

  • Norrlands Universitetssjukhus

    Umeå, 901 85

Other trials in Sweden

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • National Cancer Centre Singapore

    Singapore, 168583

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Turkey (Türkiye)3 sites

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 06620

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575

Other trials in Turkey (Türkiye)

Denmark2 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

Poland2 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

Other trials in Poland

Hong Kong1 site

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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

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]).

Being tested
Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel
Keywords
Oncology, Xaluritamig, Cabazitaxel, Prostate cancer, Abiraterone, Enzalutamide
Medical subject headings
Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XaluritamigDrug

    Short-term IV infusion

  • AbirateroneDrug

    Oral tablets

  • EnzalutamideDrug

    Oral tablets

  • CabazitaxelDrug

    IV infusion

Study groups in NCT06691984
Study groupRoleWhat they receive
XaluritamigExperimentalParticipants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion.
Receives: Drug: Xaluritamig
Cabazitaxel/Abiraterone/EnzalutamideActive 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.
Receives: Drug: Abiraterone; Drug: Enzalutamide; Drug: Cabazitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Measured: Up to approximately 53 months

Secondary outcomes (31)

  1. 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)

    Measured: Up to approximately 53 months

  2. Objective Response Rate per Modified RECIST v1.1 as Assessed by BICR

    Measured: Up to approximately 53 months

  3. Duration of Response (DOR) per Modified RECIST v1.1 as Assessed by BICR

    Measured: Up to approximately 53 months

  4. Disease Control Rate per Modified RECIST v1.1 as Assessed by BICR

    Measured: Up to approximately 53 months

  5. Time to Response (TTR) per Modified RECIST v1.1 as Assessed by BICR

    Measured: Up to approximately 53 months

  6. Time to First Symptomatic Skeletal Events (SSE)

    Measured: Up to approximately 53 months

  7. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to approximately 53 months

  8. Change from Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Score

    Measured: Baseline and approximately 53 months

  9. Change from Baseline in BPI-SF Pain Intensity Scale Score

    Measured: Baseline and approximately 53 months

  10. Change from Baseline in BPI-SF Pain Interference Scale Score

    Measured: Baseline and approximately 53 months

  11. Change from baseline in the European Quality of Life 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score

    Measured: Baseline and approximately 53 months

  12. Change from baseline in the EQ-5D-5L Visual Analogue Scale (VAS)

    Measured: Baseline and approximately 53 months

  13. Change from Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score and Subscale Score

    Measured: Baseline and approximately 53 months

  14. Time to Worsening in BPI-SF Worst Pain Score

    Measured: Up to approximately 53 months

  15. Time to Worsening in BPI-SF Pain Intensity Scale Score

    Measured: Up to approximately 53 months

  16. Time to Worsening in BPI-SF Pain Interference Scale Score

    Measured: Up to approximately 53 months

  17. Time to Worsening in FACT-P Total Score

    Measured: Up to approximately 53 months

  18. Time to Pain Improvement in Participants with Moderate/Severe Pain at Baseline

    Measured: Up to approximately 53 months

  19. Time to Pain Improvement after Worsening in BPI-SF Pain Intensity Scale Score

    Measured: Up to approximately 53 months

  20. Time to Pain Improvement after Worsening in BPI-SF Pain Interference Scale

    Measured: Up to approximately 53 months

  21. Number of Patient-Reported Symptomatic AEs per Patient-reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library

    Measured: Up to approximately 53 months

  22. Patient-Reported Summary Scores for Overall Bother of Side Effects per FACT-P

    Measured: Up to approximately 53 months

  23. Percentage of Participants Achieving a ≥50% Reduction in Prostate-specific Antigen (PSA) (PSA50)

    Measured: Up to approximately 53 months

  24. Percentage of Participants Achieving a ≥90% Reduction in PSA (PSA90)

    Measured: Up to approximately 53 months

  25. Maximum Serum Concentration (Cmax) of Xaluritamig

    Measured: Up to approximately 53 months

  26. Time to Cmax (Tmax) of Xaluritamig

    Measured: Up to approximately 53 months

  27. Minimum Serum Concentration (Cmin) of Xaluritamig

    Measured: Up to approximately 53 months

  28. Area Under the Concentration-time Curve (AUC) of Xaluritamig

    Measured: Up to approximately 53 months

  29. Accumulation Following Multiple Dosing of Xaluritamig

    Measured: Up to approximately 53 months

  30. Half-life (t1/2) of Xaluritamig

    Measured: Up to approximately 53 months

  31. Number of Participants with Anti-xaluritamig Antibody

    Measured: Up to approximately 53 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start9 Dec 2024
  3. Primary completion2 Jan 2029 (estimated)
  4. Study completion30 Jul 2029 (estimated)

Resources

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
707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06691984
Sponsor's protocol ID
20230005
Other IDs
2024-513968-25
Status last verified
May 2026
First submitted
14 Nov 2024
Last updated
15 May 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xaluritamig, Abiraterone and Enzalutamide in people with Metastatic Castration-resistant Prostate Cancer, run by Amgen at 164 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, Japan, France, Germany, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 53 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06691984.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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