Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
Description
Brief Summary
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.
Detailed Description
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
parameters.
OUTLINE:
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.
Phase
N/AInclusion 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
Sites
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.