drugset / Trial / NCT04186845

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

NCT04186845

Phase 3 Completed 391 enrolled Blue Earth Diagnostics Parexel · collab
NaSingle-groupOpen-labelDiagnostic

Summary

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

Timeline

Start
2020-05-04
Primary completion
2021-04-28
Completion
2021-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-rhPSMA-7.3 Diagnostic / imaging agent 296 mbq Intravenous

Indications