drugset / Trial / NCT01808222

FACBC for Recurrent Prostate Cancer

NCT01808222

Phase 2 Completed 25 enrolled David M. Schuster, MD
NaSingle-groupOpen-labelDiagnostic

Summary

The investigators will perform a study with 25 patients in whom the investigators have a strong suspicion of prostate cancer that has returned to the body after having an initial treatment. The major goal of the investigation is to see whether anti-\[18F\] FACBC PET-CT and MRI imaging individually will be useful in the detection of local and extraprostatic recurrence of prostate cancer. Routine blood test will be done on the day of the FACBC scan and one week later as required by the FDA. All patients will undergo biopsy of the prostate as clinically appropriate per standard of care. If either the FACBC or MRI scans indicate cancer recurrence, the subject's cancer site(s) will also be biopsied as clinically appropriate.

Timeline

Start
2013-11
Primary completion
2017-09-13
Completion
2017-09-13

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-fluciclovine Diagnostic / imaging agent 370 mbq Intravenous

Indications