Metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
Lu177-EB-PSMA617 Prostate-Specific Membrane Antigen Inhibitor Therapy in Patients With Castration-Resistant Prostate Cancer
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2022 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | National Institute for Biomedical Imaging and Bioengineering (NIBIB) |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the PSA and standardized uptake value of 68Ga-PSMA before and after the treatment in mCRPC | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake in lesions will be measured. | 1 year | |
Secondary | Adverse events collection | Adverse events after the treatment of patients will be followed and assessed | patients will be monitored throughout the whole treatment period. Patients will be followed up every 3 month until 1 year for a long-term follow-up period. |
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