800-872-2273

Clinical Trials and Studies

Your participation matters. Help us discover and cure!

Contact us at (800) USC-CARE (800-872-2273)

We're sorry, but this trial is no longer enrolling volunteers.

Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer

Description

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.

Phase

N/A

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.)

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.

Powered by SC CTSI