177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 177Lu-EB-PSMA-617 dosimetry calculation All patients were intravenous injected with single dose 0.80-1.1 GBq (21.5-30 mCi) of 177Lu-EB-PSMA-617, then monitored at 2, 24, 72, 120 and 168 hours post-injection. |
Drug: 177Lu-EB-PSMA-617
accepted intravenous injection of 177Lu-EB-PSMA-617 and monitored at 2, 24, 72, 120 and 168 hours post-injection.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Adverse events collection [2 months]
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed
Eligibility Criteria
Criteria
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 exclusion criteria were 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 and 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
- Study Chair: Zhaohui Zhu, MD,PHD, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PekingUMCH-NM16
- ZIAEB000073