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

• Status: Recruiting
• Trial end date: 2023-11-15
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

Criteria

Inclusion Criteria:

• progressive metastatic castration-resistant prostate cancer

• tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT

Exclusion Criteria:

• a serum creatinine level of more than 150 μmol per liter

• a hemoglobin level of less than 10.0 g/dl

• a white-cell count of less than 4.0× 109/L

• a platelet count of less than 100 × 109/L

• a total bilirubin level of more than 3 times the upper limit of the normal range

• a serum albumin level of more than 3.0 g per deciliter

• cardiac insufficiency