drugset / Trial / NCT03187990

Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA

NCT03187990

Completed 52 enrolled Irene Burger
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of \[68Ga\]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.

Timeline

Start
2017-03-03
Primary completion
2021-08-03
Completion
2021-08-03

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-PSMA-1007 Diagnostic / imaging agent
Subject 68Ga-PSMA-11 Diagnostic / imaging agent

Indications