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)

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).

Participation Guidelines

Ages: 18 years and older

Gender: Male only

Advanced Accelerator Applications International SA

Start Date: 03/04/2019

End Date: 06/03/2019

Last Updated: 04/25/2019

Study HIC#: 2000023359