Phase 1b Study of 177Lu-PSMA-617 With Liver-Directed Therapy for Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety and effects of combining a targeted radionuclide therapy called 177Lu-PSMA-617 with liver-directed treatments in men who have metastatic castration-resistant prostate cancer mCRPC with liver metastases. This phase 1b open-label study focuses on patients whose cancer has progressed despite prior androgen pathway inhibitor treatments. The study aims to understand how well this combined approach controls disease and its safety profile using standard response criteria. Participants receive up to six cycles of 177Lu-PSMA-617 intravenously every 6 weeks. Those with PSMA-negative liver lesions receive a single session of liver-directed therapy such as transarterial chemoembolization TACE or ablation before starting the radionuclide treatment. If liver disease remains stable or progresses after two cycles, additional liver-directed therapy may be given. Treatment continues until disease progression, unacceptable side effects, or study completion. During the study, participants undergo imaging tests like PETCT scans, tumor biopsies, and complete questionnaires to assess responses. Researchers monitor safety through adverse event reports and measure outcomes such as objective response rates, progression-free survival, overall survival, and prostate-specific antigen PSA declines. Follow-up visits occur every 3 months for up to 5 years after the last treatment to track long-term effects.

177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer