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Xaluritamig plus abiraterone versus doctor's choice for chemo‑naïve metastatic castration‑resistant prostate cancer

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

Phase 3 Interventional Amgen · NCT07213674

This phase 3 test checks whether adding xaluritamig to abiraterone helps men with chemotherapy‑naïve metastatic castration‑resistant prostate cancer live longer than standard doctor‑chosen options (docetaxel, cabazitaxel, or abiraterone alone).

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years and up
SexMale
SponsorAmgen Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations126 sites (Goodyear, Arizona and 125 other locations)
Trial IDNCT07213674 on ClinicalTrials.gov

What this trial studies

Participants with chemotherapy‑naïve metastatic castration‑resistant prostate cancer who meet imaging and progression criteria are assigned to receive xaluritamig plus abiraterone or an investigator's choice of docetaxel, cabazitaxel, or abiraterone. The primary goal is to compare overall survival between the two groups. Key eligibility includes histologically confirmed prostate adenocarcinoma, at least one metastatic lesion on recent imaging, and documented disease progression per PSA or radiographic criteria. Participants will be followed for survival and disease progression outcomes.

Who should consider this trial

Good fit: Men aged 18 or older with histologically confirmed prostate adenocarcinoma, metastatic castration‑resistant disease with at least one lesion on recent imaging, documented progression, and no prior chemotherapy for metastatic disease are the ideal candidates.

Not a fit: Patients with mixed histology (including neuroendocrine features), those who received prior chemotherapy for metastatic prostate cancer, or those who do not meet the specified progression or imaging requirements are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could prolong overall survival and delay disease progression for men with chemo‑naïve mCRPC.

How similar studies have performed: Combining novel targeted agents with abiraterone has produced mixed results in prior trials, and using xaluritamig in this combination is a novel approach without established proof of benefit yet.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

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.
* 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.

Where this trial is running

Goodyear, Arizona and 125 other locations

+76 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castration-resistant Prostate CancerProstate CancerChemotherapy-naïve Metastatic Castration-resistant Prostate CancerXaluritamigAbirateroneAbiraterone AcetateDocetaxelCabazitaxel
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.