Tests xaluritamig with abiraterone in advanced prostate cancer
Compares xaluritamig plus abiraterone with standard treatment choices in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Key facts
- Where
- Montreal, Sherbrooke, and Toronto, CanadaSee the 4 sites
- Phase
- Phase 3
Where in Canada
- Centre de recherche du Centre hospitalier de l'Université de MontréalMontreal, CanadaTaking people
- Sir Mortimer B Davis - Jewish General HospitalMontreal, CanadaTaking people
- CIUSSS de L'Estrie - CHUS - Hopital FleurimontSherbrooke, CanadaTaking people
- Sunnybrook Research Institute Sunnybrook Health Sciences CentreToronto, CanadaTaking people
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?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT07213674
- Record updated
- 20 October 2026
- Original description
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 full original descriptionShow less
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).
Inclusion: 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: 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 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; Disease Related:; Participants with a history of central nervous system (CNS) metastases; Prior disease progression on or intolerance to abiraterone.