Phase I Study of 161Tb-PSMA-I&T Radioligand Therapy in Taiwanese Men with Metastatic Castration-Resistant Prostate Cancer

What this Trial Is About

Researchers are evaluating 161Tb-PSMA-I&T, a new type of radioligand therapy using Terbium-161, in Taiwanese men with metastatic castration-resistant prostate cancer mCRPC. This advanced form of prostate cancer no longer responds to hormone therapies and other treatments. The study aims to assess the safety, how the drug moves and distributes in the body, and its initial effectiveness compared to current treatments using Lutetium-177. The trial is a Phase I dose escalation study designed to inform future research and treatment strategies. Participants will receive one of three doses of 161Tb-PSMA-I&T 120, 150, or 200 mCi administered by slow intravenous injection every six weeks for three cycles. The study will establish a production process for the therapy and monitor how it behaves in the body. Each dose level will be evaluated in sequence to determine safety and appropriate dosing for future trials. During the study, participants will undergo blood tests, imaging scans, and other assessments to monitor treatment effects and safety over at least 36 weeks. Researchers will track any treatment-related side effects and evaluate disease progression using specific imaging techniques and PSA levels. Patients will be monitored for organ function and overall health, with the study lasting until the post-treatment surveillance period concludes.

Exploring Auger-Enhanced PSMA-Targeted Radioligand Therapy: A First-in-Taiwan Clinical Study of 161Tb-PSMA-I&T