Phase 12 Study of STEAP1 CART Cell Therapy with Enzalutamide for Men with Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are investigating a phase III trial to evaluate the safety and effects of a cell therapy called STEAP1 CART combined with enzalutamide in men with metastatic castration-resistant prostate cancer mCRPC. This type of prostate cancer continues to grow despite treatments that lower androgen levels and has spread beyond the prostate. The study aims to explore a new immune-based treatment approach for this serious condition, which remains incurable with current therapies. STEAP1 CART involves modifying a patients immune T cells to better target prostate tumor cells, while enzalutamide blocks male hormones that help cancer grow. Participants undergo several procedures including leukapheresis to collect T cells, followed by chemotherapy with cyclophosphamide and fludarabine before receiving the STEAP1 CART infusion. Enzalutamide is taken orally starting on the day of cell infusion and daily thereafter unless disease progresses or side effects occur. Tumor biopsies are performed at the beginning, after two weeks, and optionally at progression. Imaging scans such as bone scans, CT, MRI, or PET are done throughout the study, along with blood tests and heart function evaluations like echocardiography or MUGA scans. During the study, participants are closely monitored with scheduled follow-ups at 2, 3, 4, 5, 6, 9, and 12 months, then every 6 months up to 5 years, and yearly up to 15 years. Researchers will track treatment-related side effects, tumor responses, progression-free and overall survival, and prostate-specific antigen levels. This long-term monitoring helps assess the therapys impact and safety over time.

Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer