Description:
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.
Title
- Brief Title: 177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer
- Official Title: Safety and Dosimetry of 177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
PekingUMCH-NM16
- SECONDARY ID:
ZIAEB000073
- NCT ID:
NCT03403595
Conditions
- Metastatic Castration-resistant Prostate Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| 177Lu-EB-PSMA-617 | | 177Lu-EB-PSMA-617 dosimetry calculation |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 177Lu-EB-PSMA-617 dosimetry calculation | Experimental | 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. | |
Eligibility 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.
| Maximum Eligible Age: | 80 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | Accepts Healthy Volunteers |
Primary Outcome Measures
| Measure: | Standardized uptake value of 177Lu-EB-PSMA617 in normal organs and metastatic castration-resistant prostate cancer. |
| Time Frame: | 1 year |
| Safety Issue: | |
| Description: | 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
| Measure: | Adverse events collection |
| Time Frame: | 2 months |
| Safety Issue: | |
| Description: | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Peking Union Medical College Hospital |
Last Updated
January 18, 2018
