Xaluritamig vs Other Treatments for Prostate Cancer

This trial aims to determine if a new drug, xaluritamig, extends the lives of people with advanced prostate cancer compared to other treatments. It will compare xaluritamig to cabazitaxel, a chemotherapy, or other hormone therapies targeting cancer growth. Men with prostate cancer that has spread and progressed despite previous treatments might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

The trial protocol does not specify if you must stop taking your current medications, but it does require that you have not had any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before starting the study treatment, except for ongoing androgen suppression therapy.

Research has shown that xaluritamig is generally safe for people with prostate cancer. In earlier studies, most patients who took xaluritamig experienced only mild side effects. A common issue was mild cytokine release syndrome (CRS), which usually occurred during the first treatment cycle. CRS can cause symptoms like fever or tiredness, but it was not severe for most participants.

Researchers are excited about Xaluritamig for prostate cancer because it offers a fresh approach by targeting metastatic castration-resistant prostate cancer (mCRPC) with a novel mechanism of action. Unlike standard treatments like cabazitaxel, abiraterone, and enzalutamide, which focus on hormone pathways or chemotherapy, Xaluritamig is designed to be administered as an intravenous infusion, potentially allowing for more direct and controlled delivery of the therapeutic agent. This innovative approach could provide new hope for patients who have limited options with existing treatments.

In this trial, participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive either Xaluritamig or other treatments. Studies have shown that Xaluritamig, a new treatment that aids the immune system, has promising results for advanced prostate cancer unresponsive to hormone therapy. It targets a specific protein called STEAP1 on prostate cancer cells and activates the immune system to attack these cells. In early studies, patients who had tried several other treatments showed encouraging responses to Xaluritamig. The side effects were generally manageable, indicating they were not too severe for most patients. Overall, these findings suggest that Xaluritamig could be an effective option for this type of prostate cancer.¹²³⁵⁶