225Ac-J591 Plus 177Lu-PSMA-I&T for mCRPC

Summary

Participation Requirements

Description

This clinical trial is for men with progressive metastatic castration-resistant prostate cancer (mCRPC). The two primary objectives of this trial are to determine the highest dose of 225Ac-J591 and 177Lu-PSMA-I&T that can be administered together (also known as maximum tolerated dose) and to determi...

This clinical trial is for men with progressive metastatic castration-resistant prostate cancer (mCRPC). The two primary objectives of this trial are to determine the highest dose of 225Ac-J591 and 177Lu-PSMA-I&T that can be administered together (also known as maximum tolerated dose) and to determine the effectiveness of the drug combination. Patients who choose to participate in this study will have a screening visit to determine whether or not they are eligible for the study. The phase I component is a 3+3 dose-escalation design, with maximum two cohorts. 177Lu-PSMA-I&T will be given at a fixed dose of 6.8 GBq. 225Ac-J591 will be given starting at 30 KBq/kg, with a subsequent dose-escalation by an increment of 10 KBq/kg to 40 KBq/kg. The two drugs will be co-administered every 8 weeks, for 2 cycles. Once the maximum tolerated dose has been established, the phase II component will enroll up to 24 patients. The primary efficacy measure will be proportion of patients with PSA decline and proportion of patients with 50%+ PSA decline. Other objectives include to determine the radiographic response rate, biochemical progression-free survival, and overall survival. During the study, patients will be closely monitored for adverse events (side effects); weekly x4 weeks, then every 2 weeks until completion of therapy, then every 4 weeks until patients start another therapy. Long-term follow-up will be every 6 months, for 3 years. During the phase I component, the adverse event assessment phase will be a minimum of 8 weeks after the last dose of 225Ac-J591 and 177Lu-PSMA-I&T. At screening, week 12, and week 24, patients will undergo imaging. Imaging will include 68Ga-PSMA-11 PET/CT. 68Ga-PSMA-11 is comprised of gallium-68, a radiotracer, linked to PSMA-11, a molecule that binds to PSMA. Patients with PSMA-positive tumors are eligible for the study. Additional imaging includes SPECT imaging on day 8 of each cycle, to evaluate radiation uptake into the tumors.

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