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 prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
- Participants must have at the time of diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results:
- De novo mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs AND started androgen deprivation therapy (ADT)a type of hormone therapy used to reduce testosterone levels to treat prostate cancer (luteinising hormone-releasing hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body [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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening. Prior docetaxel treatment is not permitted.
- Participants must have at the time of diagnosis:
- High-volume metastatic disease defined as presence of visceral metastasiswhen the cancer has spread to other parts of the body, also known as mets 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 tissuetissue/the material that joins, holds up or surrounds inside body parts such as fat, muscle, ligaments and lining around joints or visceral metastases, either by contrast enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imagingtests that create detailed images of areas inside the body (MRI) scan.
- PSA not progressing per PCWG3 following the initial PSA nadira point in time, after chemotherapy, when blood count is lowest after starting ADT.