Status:
UNKNOWN
Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Metastatic Castration-resistant Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE1
Brief 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 ac...
Detailed Description
Prostate cancer (PC) is the second most common cancer worldwide in men, with persistently high numbers dying from this disease. Recent studies have demonstrated the possibility of 177Lu-PSMA-617 thera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03780075
Start Date
April 15 2018
End Date
December 1 2022
Last Update
May 12 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China