Clinical Trials Logo

Clinical Trial Summary

A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.


Clinical Trial Description

This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I&T as treatment compared to standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer. The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET imaging. Patients will be randomized at a ratio of 2:1 to receive either 177Lu-PSMA-I&T or hormone therapy (abiraterone or enzalutamide) respectively. Patients randomized to the investigational product will receive up to 4 treatments every 6 weeks at a dose of 200 mCi (7.4 GBq). All patients will be followed for adverse events and safety labs throughout the course of the study. Progression of disease will be assessed radiographically using Prostate Working Group Criteria 3 (PWGC3) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of conventional imaging as well as PSA levels and symptom recording throughout the course of treatment. From the patients randomized into the 177Lu-PSMA-I&T arm, a total of 30 patients will be enrolled invited to participate in the a pharmacokinetic and radiation dosimetry sub-study at selected participating clinical sites. Sub-study participants will receive planar and SPECT imaging after each treatment cycle for dosimetry analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05204927
Study type Interventional
Source Curium US LLC
Contact Darcy Denner
Phone 314-506-3512
Email [email protected]
Status Recruiting
Phase Phase 3
Start date February 14, 2022
Completion date June 2029