Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
Brief SummaryThis 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 DescriptionI. 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.
Inclusion and Exclusion Criteria
- Patients must have rising serum PSA level defined as at least 2 consecutive rises in PSA documented over a reference value; the first rising PSA (2nd measure) should be taken at least 14 days after the reference value; a confirmatory PSA measure (3rd measure) obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd measure; initial (reference) PSA must be >= 4 and the two consecutive rises must all be >= 0.5 over the previous PSA measure
- Suspected prostate cancer based on elevated PSA level (>= 4) and abnormal digital rectal examination with clinical decision to proceed to prostate biopsy
- Elevated PSA level (>= 4) and a prior negative standard biopsy of the prostate
- Creatinine =< 1.5 x the institutional upper limit of normal
- Already scheduled to undergo biopsy
- History of cancer other than prostate cancer (except squamous cell carcinoma of the skin that has been treated with curative intent)
- History of myocardial infarction within 6 months of the enrollment
- Active infection (except mild upper respiratory infections)
- Active prostatitis
- History of recent fracture (within 3 months of recruitment), complicated non-healing fracture, hip arthroplasty, knee arthroplasty
- Unable to undergo MR imaging (e.g. cardiac device, metals, claustrophobia, etc.)
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