A Phase 1/2 Open-label, Multi-center, Safety and Tolerability Study of a Single Dose of 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)
Prostate | Diseases of the Kidney & Urinary Tract | Men's Health
What is the purpose of this trial?
Assessment of 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 68Ga-PSMA-R2, to assess the pharmacokinetics (PK), biodistribution, and dosimetry of 68Ga-PSMA-R2, and to establish the optimal imaging method for determining location and burden of positive lesions in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).
- Ages18 years and older
- GenderMale only
- Trial withAdvanced Accelerator Applications International SA
- Start Date03/03/2019
- End Date06/02/2019
- Last Updated04/25/2019
- Study HIC#2000023359