Using 68Ga-PSMA-PETCT Scans and Genetic Testing to Help Choose Radium-223 Treatment for Men with Advanced Prostate Cancer

What this Trial Is About

Researchers are evaluating the use of Radium-223, a radionuclide therapy, in men with metastatic castration resistant prostate cancer mCRPC who have bone metastases. The study aims to understand if the presence of extraskeletal lesions detected by a sensitive 68Ga-PSMA-PETCT scan affects the response to Radium-223 treatment. This prospective clinical study explores whether this advanced imaging method can better predict treatment outcomes for patients with bone-only disease as identified by conventional scans. Participants will receive up to six cycles of Radium-223 therapy according to current guidelines, along with standard systemic treatments like androgen deprivation therapy and bone protective agents. Each patient will have a baseline 68Ga-PSMA-PETCT scan and will complete patient-reported outcome questionnaires via an app during treatment. Blood samples will be collected to analyze circulating tumor DNA. At clinical progression, a second 68Ga-PSMA-PETCT scan will be performed to assess disease changes and the value of this imaging for treatment response evaluation. Throughout the study, participants will be monitored by conventional imaging methods and clinical evaluations to track progression-free survival up to 28 weeks. Patient-reported outcomes and genomic biomarkers will also be assessed periodically. Follow-up will continue every six months for up to two years to record overall survival. The treating physicians will not see the initial 68Ga-PSMA-PETCT results to reduce bias. This comprehensive monitoring aims to improve understanding of Radium-223 treatment effects and refine patient selection for this therapy.

The Radium-select Study