RecruitingMetastatic Castration-resistant Prostate Cancer

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Eligible age

18+ yrs

Accepts

Men

Locations

23 states

Healthy volunteers

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About this study

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).

Sponsor: Amgen

You may qualify if…

✓ 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).

You may not qualify if…

✕ 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: