Phase II Study of Cabozantinib and Atezolizumab for Treating Metastatic Castration-Resistant Prostate Cancer with Non-Measurable Disease

What this Trial Is About

Researchers are evaluating cabozantinib and atezolizumab in men with metastatic castration-resistant prostate cancer mCRPC that has spread beyond the pelvis. This phase II trial explores whether this combination can shrink tumors and control disease in patients with non-measurable metastatic cancer. The study also aims to assess treatment effects on prostate-specific antigen PSA levels, radiographic progression, overall survival, safety, and biomarkers related to treatment response and resistance. Patients receive cabozantinib orally once daily for 21 days and atezolizumab intravenously on day 1 of each 21-day cycle. Treatment continues until disease progression or unacceptable side effects occur. After finishing study treatment, patients are followed up at 30 days and then every three months until disease progression or new therapy begins. During the study, patients will have their disease control rate assessed at 24 weeks. Researchers will monitor PSA progression-free survival, PSA 50% response rate, radiographic progression-free survival, overall survival, and adverse events. Tissue and tumor biomarkers will be analyzed to understand how the treatment works and why resistance may occur. Safety and treatment effects are closely monitored throughout the trial, which may last up to several years for some participants.

Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer