Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

This study is looking for men aged 18 or older who have advanced prostate cancer that has spread and is no longer responding to initial hormone treatments. Your doctor must have confirmed your prostate cancer as adenocarcinoma, and it cannot be mixed with other types of cancer.

You must have signs of the cancer getting worse, which could be seen in your blood tests (like PSA levels), scans (like CT, MRI, or bone scans showing new or growing spots), or both. You must have already had surgery to remove your testicles or be receiving ongoing hormone therapy to keep your testosterone levels very low. You also need to have tried at least one hormone-blocking medicine before (like enzalutamide or abiraterone) and had one type of chemotherapy (taxane medicine) for your advanced prostate cancer.

Your general health and ability to perform daily activities need to be good, as assessed by a doctor. Specific types of earlier treatments might affect whether you can join, so your medical history will be carefully reviewed.

If you decide to take part, you will be assigned to receive either the new medicine, Xaluritamig, or one of the standard treatments (Cabazitaxel or another hormone-based medicine chosen by your doctor). You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. These tests will help the doctors keep track of your cancer and any side effects you might experience.

The specific schedule for visits and tests will depend on the treatment you receive, but you can expect frequent monitoring throughout the study. The total duration of your participation will vary depending on how you respond to the treatment and the study's requirements. You will receive the study medication as directed by the research team. After treatment, there will likely be follow-up appointments to continue monitoring your long-term health and the effects of the treatment.