drugset / Trial / NCT04910425

PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer

NCT04910425

NaSingle-groupOpen-labelDiagnostic

Summary

This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.

Timeline

Start
2023-06-17
Primary completion
2026-06-17
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-DCFPyL Diagnostic / imaging agent Intravenous
Background Gadobenate dimeglumine Diagnostic / imaging agent Intravenous
Background Gadobutrol Diagnostic / imaging agent Intravenous

Indications