drugset / Trial / NCT05613738

177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer

NCT05613738 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-PSMA-EB-01, a new PSMA-specific radiopharmaceutical, in patients with metastatic castration resistant prostate cancer (mCRPC) who will undergo radioligand therapy (RLT). All patients underwent 68Ga-PSMA and 18F-FDG PET/CT for selection and were randomly divided into three groups of 3 people each.The three groups received an approximately 1.11 GBq (30mCi), 1.85 GBq (50 mCi) and 2.59 GBq (70mCi) of 177Lu-PSMA-EB-01 up to 2 cycles, respectively.

Timeline

Start
2022-11-23
Primary completion
2025-06-30
Completion
2025-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-PSMA-EB-01 Other / unclassified 1110 mbq Intravenous
Subject 177Lu-PSMA-EB-01 Other / unclassified 1850 mbq Intravenous
Subject 177Lu-PSMA-EB-01 Other / unclassified 2590 mbq Intravenous