Phase III Study of Actinium 225Ac rhPSMA-10.1 Injection for Men with Advanced Metastatic Castration-Resistant Prostate Cancer After Lutetium-PSMA Treatment

What this Trial Is About

This trial focuses on men with advanced metastatic castration-resistant prostate cancer mCRPC, a condition where prostate cancer continues to grow despite treatments that lower testosterone. Researchers aim to learn more about Actinium 225Ac rhPSMA-10.1, a new injectable radioactive drug designed to target and destroy prostate cancer cells, especially in men whose cancer has progressed despite prior treatments including Lutetium-PSMA. The study includes Phase I and Phase II components to evaluate safety and anti-tumor activity. Participants will receive Actinium 225Ac rhPSMA-10.1 every six weeks, up to six doses. Phase I will determine safe dosage levels through dose escalation or de-escalation, including some men who have not previously received Lutetium-PSMA. Phase II will treat men who have responded to Lutetium-PSMA using the dose established in Phase I. Throughout the trial, participants will have regular check-ups, blood tests, and scans to monitor treatment effects and safety. During the study, men will be closely monitored weekly by trial doctors, sometimes remotely, to assess tolerance and side effects. Blood tests and imaging scans will be done regularly to evaluate cancer response. Some participants will provide blood samples for genetic analysis. After completing treatment, participants will remain in follow-up to study long-term effects. The main outcomes measured include dose-limiting toxicities in Phase I and anti-tumor response in Phase II, with monitoring lasting up to five years.

ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium