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

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: Male

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), 1.85GBq (50 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Treatments: 177Lu-EB-PSMA-617

Criteria

Inclusion Criteria:

• progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy.

• Distant metastases with high PSMA expression confirmed by 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617.

Exclusion Criteria:

• a serum creatinine level of more than 150μmol 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 including carcinoid heart valve disease,

• a severe allergy or hypersensitivity to radiographic contrast material,

• claustrophobia, and pregnancy or breastfeeding.