Back to Search Results- Recruiting
- Treatment
- Interventional
- Randomized
- Drug
- Peking Union Medical College Hospital
- 18 - 80 Years
Study Purpose
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.
Intervention
Drug : 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01
Drug : 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01
Drug : 2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01
Eligibility Requirements
progressive metastatic castration-resistant prostate cancer
tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT
Minimum age: 18
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
Recruiting status
Recruiting
Estimated enrollment
9
Study start date
Nov 23, 2022
Study end date
Nov 15, 2025
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug
Study phase
NA
Allocation
Randomized
Sponsor:
Peking Union Medical College Hospital
Collaborator:
N/A
Investigator:
Zhaohui Zhu Zhu, MD
N/A
Publications
N/A
Websites
N/A
NCT05613738
| Clinic | Location | Investigator | Distance | RECRUITING STATUS | Contact |
|---|