Brief Summary
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Intervention / Treatment
- Drug: Xaluritamig
- Drug: Darolutamide
- Drug: Abiraterone
Inclusion Criteria
- Participants must have histological, pathological, and/or cytological confirmation of adenocarcinomacancer arising from mucus-producing glands in organs of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
- Participants must have at the time of diagnosis:
- De novo mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer AND started androgen deprivation therapy (ADT)a type of hormone therapy used to reduce testosterone levels to treat prostate cancer (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomyremoval of one or both testicles, also known as orchidectomy) with or without androgen receptor pathway inhibitor (ARPI) (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted.
- Participants must have at the time of diagnosis:
- High-volume metastatic disease defined as presence of visceral metastasis and/or ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis.
- Documented metastatic disease either by a positive bone scana type of medical imaging that uses a radioactive tracer to detect bone conditions or abnormalities, or for soft tissue or visceral metastases, either by contrast enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan.
- PSA not progressing per PCWG3 following the initial PSA nadir after starting ADT.