drugset / Trial / NCT06084338

Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

NCT06084338

Phase 2 Recruiting 60 enrolled VA Office of Research and Development
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.

Timeline

Start
2023-12-14
Primary completion
2027-11-29
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-PSMA-617 Other / unclassified
Subject Testosterone Small molecule 1.62 % Topical

Indications