A Study of Xaluritamig for Metastatic Castration-Resistant Prostate Cancer
This study is for men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to treatments that lower testosterone). It compares a new combination of drugs, xaluritamig and abiraterone, against standard treatments like docetaxel, cabazitaxel, or abiraterone alone. The main goal is to see if the xaluritamig and abiraterone combination helps people live longer (overall survival). You may be able to join if you are 18 or older and have a confirmed diagnosis of prostate adenocarcinoma. The study aims to enroll 750 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 750 participants. It compares two different treatment approaches.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for overall survival for up to approximately 51 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07213674
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentAmgen
~750 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:XaluritamigAbiraterone acetateDocetaxelCabazitaxel
At a glance
Recruiting sites
150 of 151 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
OS
Measured over Up to approximately 51 months
Conditions
Where it's being run
151 sites across 56 statesFrance14
Germany11
Greece8
Italy8
California6
Texas5
Portugal5
Virginia4
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
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
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 six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.
Prior disease progression on or intolerance to abiraterone.
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.
What this trial measures
- OSUp to approximately 51 months