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

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.

Inclusion Criteria:progressive metastatic castration-resistant prostate cancertumors with high PSMA expression confirmed on 68Ga-PSMA PET/CTExclusion Criteria:a serum creatinine level of more than 150 μmol per litera hemoglobin level of less than 10.0 g/dla white-cell count of less than 4.0× 109/La platelet count of less than 100 × 109/La total bilirubin level of more than 3 times the upper limit of the normal rangea serum albumin level of more than 3.0 g per decilitercardiac insufficiency