drugset / Trial / NCT03780075

Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer

NCT03780075

RandomizedParallel-groupOpen-labelTreatment

Summary

In prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to increase the tumor accumulation and retention for radioligand therapy,and then the investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients with mCRPC. This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi), 2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously. All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.

Timeline

Start
2018-04-15
Primary completion
2020-09-01
Completion
2022-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-EB-PSMA-617 Other / unclassified 1110 mbq Intravenous
Subject 177Lu-EB-PSMA-617 Other / unclassified 2000 mbq Intravenous
Subject 177Lu-EB-PSMA-617 Other / unclassified 3700 mbq Intravenous

Indications