drugset
drugset / Trial / NCT03439033

Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

NCT03439033 ↗

Phase 2 Terminated 273 enrolled Weill Medical College of Cornell University Cancer Research & Treatment Fund, Inc. · collab
Non-randomizedParallel-groupOpen-labelScreening

Summary

This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.

Timeline

Start
2018-04-03
Primary completion
2021-05-05
Completion
2021-05-05

Outcome

Met primary endpoint

Stopped: “Study Drug was FDA approved Summer 2021”

registry analysis (superiority test); PSMA PET/MRI and PET/CT Scan vs MRI Scan; p <0.0001; Risk Difference (RD) 0.42 (95% CI 0.30 to 0.53); McNemar NCT03439033 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-PSMA-11 Diagnostic / imaging agent — Other

Indications

prostate cancer