drugset / Trial / NCT03403595
177Lu-EB-PSMA617 in Patients With Metastatic Castration-resistant Prostate Cancer
Phase 1
Unknown
30 enrolled
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-12-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-EB-PSMA-617 | Other / unclassified | 800 mbq | Intravenous |
| Subject | 177Lu-EB-PSMA-617 | Other / unclassified | 1100 mbq | Intravenous |