drugset / Trial / NCT03490032
68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)
Non-randomizedSequentialOpen-labelDiagnostic
Summary
This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).
Timeline
- Start
- 2018-05-23
- Primary completion
- 2019-08-20
- Completion
- 2019-09-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68Ga-PSMA-R2 | Diagnostic / imaging agent | 3 mbq/kg | Intravenous |