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Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
This pilot clinical trial studies how well fluorine F 18 d-FMAU (18F-FMAU) positron emission
tomography (PET)/computed tomography (CT) works in diagnosing and characterizing prostate
cancer. A PET/CT scan is an imaging test that uses a small amount of radioactive tracer that
is given through the vein to take detailed pictures of areas inside the body where the tracer
is taken up. Radiotracers such as 18F-FMAU may help to find the cancer and see how far the
disease has spread.
I. To perform a prospective clinical imaging evaluation of 18F-FMAU PET/CT in addition to
multiparametric magnetic resonance imaging (mpMRI) and standard transrectal ultrasound
(TRUS)-guided 12-core biopsy for detection and localization of primary tumor in 40 men with
suspected prostate cancer based on elevated/rising prostate specific antigen level, abnormal
digital rectal exam, or those with prior negative standard biopsy who are now returning for a
standard of care follow-up.
II. To examine the associations between the PET derived imaging parameters, serum PSA, mpMRI
parameters (apparent diffusion coefficient [ADC], Ktrans) and the biopsy histopathology
Patients receive radiotracer F 18 d-FMAU intravenously (IV) over 1 minute and then undergo
18F-FMAU PET/CT on day 1. Patients then undergo standard of care multiparametic MRI and
standard of care transrectal ultrasound-guided biopsy.
After completion of study treatment, patients are followed up at 24-96 hours.
Inclusion and Exclusion Criteria
- Scheduled to undergo standard of care biopsy for suspected prostate cancer, or
re-biopsy with prior negative systemic biopsy or restaging biopsy in patients with
known prostate cancer on active surveillance
- History of myocardial infarction within 6 months of the enrollment
- Active infection (except mild upper respiratory infections)
- Active prostatitis
- Non-prostate cancers currently on treatment
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.