Taking people in ItalyPhase 3
Tests xaluritamig with abiraterone in men with advanced prostate cancer
Compares xaluritamig plus abiraterone with standard drug choices in men with advanced prostate cancer.
Key facts
- Who runs it
- Amgen Inc.
- Where
- Foggia, Milan, Modena, Orbassano, Peschiera del Garda, Rozzano, and Trento, ItalySee the 8 sitesAlso in 8 other countries, 65 sites
- Trial code
- EU 2025-520555-89-00
- U1111-1324-1794
- Registry title
- Phase 3 Study of Xaluritamig Plus Abiraterone vs Investigator's Choice in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 297 people, planned
- Started
- 14 Nov 2025
- Expected to end
- 30 Aug 2032
- Type of study
- Interventional
- Record updated
- 17 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. They must not have had chemotherapy for this stage of the disease.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer (adenocarcinoma) that has spread (metastatic) and has kept growing despite castrate-level testosterone, with at least 1 metastatic lesion on imaging within 28 days before enrollment and signs of disease progression. ECOG performance status of 0 or 1.
- Earlier treatment
- Must have had prior orchiectomy and/or ongoing androgen-deprivation therapy. The cancer must have progressed on 1, and only 1, androgen receptor pathway inhibitor (enzalutamide, apalutamide, or darolutamide). No chemotherapy for metastatic castration-resistant disease. No more than 6 cycles of docetaxel earlier, in the hormone-sensitive stage. No prior progression on or intolerance to abiraterone.
- Biomarker or test result
- Testosterone at castrate level (less than 50 ng/dL or less than 1.7 nmol/L).
Main reasons for not taking part
- History of metastases in the brain or spinal cord (CNS)
- Earlier treatment targeting STEAP1 or CD3
- Radium-223 within 2 months, or radioligand therapy within 8 weeks, before the first dose
- Palliative radiotherapy within 2 weeks before the first dose
- Live or live-attenuated vaccines within 4 weeks before the first dose
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Participant has provided informed consent before initiation of any study-specific activities/procedures
- Adequate organ function
- Age greater than or equal to 18 years (or greater than or equal to 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
- mCRPC with greater than or equal to 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
- Participants must have had prior orchiectomy and/or ongoing androgren-deprivation therapy (ADT) and a castrate level of serum testosterone (less than 50 ng/dL or less than 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 less than or equal to 6 cycles of docetaxel in the mHSPC setting
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Who cannot take part
- 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
- Prior CD3-directed therapy
- 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
- 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 six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy
- Prior treatment with any chemotherapy regimen in the mCRPC setting and/or greater than 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/gonadotropin releasing hormone [LHRH/GnRH] analogue [agonist/antagonist]) is permitted
- Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment
- Participants with a history of central nervous system (CNS) metastases
- Prior disease progression on or intolerance to abiraterone
Where in Italy
Also in 8 other countries, 65 sites
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.Peschiera del Garda, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Sanitaria Universitaria Integrata Del TrentinoTrento, ItalyTaking people
About the trial
What the trial wants to find out
To compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests xaluritamig with abiraterone in men with advanced prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 17 September 2026