Metastatic Castration-resistant Prostate Cancer
Conditions
Brief summary
This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-EB-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-EB-PSMA-617. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 0.80-1.1 GBq (21.5-30 mCi) of 177Lu-EB-PSMA-617 within one week, then monitored at 2, 24, 72, 120 and 168 h after 177Lu-EB-PSMA617 administration with serial whole body planar and SPECT/CT imaging.
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. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-EB-PSMA-617 in patients with metastatic castration-resistant prostate cancer.
Interventions
DRUG177Lu-EB-PSMA-617
accepted intravenous injection of 177Lu-EB-PSMA-617 and monitored at 2, 24, 72, 120 and 168 hours post-injection.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy. Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value of 177Lu-EB-PSMA617 in normal organs and metastatic castration-resistant prostate cancer. | 1 year | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and metastatic castration-resistant prostate cancer will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events collection | 2 months | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed |
Countries
China
Contacts
Primary ContactJie Zang, MD
Outcome results
None listed