At a glance
ClinicalIndex Comparison Record- ✓Progressive metastatic castration-resistant prostate cancer
- ✓Tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT
- ✕Cardiac insufficiency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05613738N/ARecruitingUpdate OverdueUpdated 23mo ago · Completion was 12mo agoSafety and Dosimetry of 177Lu-PSMA-EB-01 in Patients With Metastatic Castration-resistant Prostate Cancer
In Brief
A clinical study evaluating 1.11 GBq (30 mCi) of 177Lu-PSMA-EB-01, 1.85 GBq (50 mCi) of 177Lu-PSMA-EB-01, and 1 other intervention for Metastatic Castration-resistant Prostate Cancer. Currently recruiting, targeting 9 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.