To hear about similar clinical trials, please enter your email below
Trial Title:
177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer
NCT ID:
NCT05613738
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01
Description:
All patients were intravenous injected with single dose 1.11 GBq (30 mCi) of
177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours
post-injection.
Arm group label:
1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01
Intervention type:
Drug
Intervention name:
1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01
Description:
All patients were intravenous injected with single dose 1.85 GBq (50 mCi) of
177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours
post-injection.
Arm group label:
1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01
Intervention type:
Drug
Intervention name:
2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01
Description:
All patients were intravenous injected with single dose 2.59 GBq (70 mCi) of
177Lu-PSMA-EB-01 then monitored at 3 hours, 24 hours, 48 hours, 72 hours, and 168 hours
post-injection.
Arm group label:
2.59 GBq (70 mCi) of 177Lu-PSMA-EB-01
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.
Detailed description:
Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific
membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors
which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based
compound, provide an effective target for the treatment of metastatic
castration-resistant prostate cancer. However, a major problem in the therapeutic use of
177Lu-PSMA-617 has been its short half-life and fast rate of clearance. The investigators
designed and synthesized a new radiopharmaceutical, named 177Lu-PSMA-EB-01. EB（Evans
Blue）can bind to albumin to slow down its plasma clearance rate, thereby increasing tumor
accumulation and reducing the total dosage of Lu-177. Hence, EB-PSMA-01 may be an option
for consideration due to limited supply of Lu-177, by which more patients may be
benefited by this version of 177Lu-EB-PSMA-01. This study was designed to investigate the
safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-01 in patients with metastatic
castration resistant prostate cancer.
Criteria for eligibility:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD
Phone:
86-13611093752
Email:
13611093752@163.com
Contact backup:
Last name:
Guochang Wang, MD
Phone:
86-18516822732
Email:
guochang1007@163.com
Start date:
November 23, 2022
Completion date:
November 15, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613738
