18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer

PRIMARY OBJECTIVES:

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.

Inclusion 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

Exclusion Criteria:

- 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.)