Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial

This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.

NCT Number	NCT06288113
Lead Sponsor	Jonsson Comprehensive Cancer Center Collaborators: Novartis Pharmaceuticals
Conditions	Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
Enrollment	40 participants
Start Date	2024-08-01
Primary Completion	2027-01-27 (estimated)
Study Completion	2028-01-27 (estimated)
Updated on ClinicalTrials.gov	2026-03-13