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

Status: Temporarily Closed to Accrual

Description

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.

Eligibility Criteria

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.)

Locations & Contacts

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Hossein Jadvar
Phone: 323-442-1107
Email: jadvar@med.usc.edu

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
USC / Norris Comprehensive Cancer Center

Principal Investigator
Hossein Jadvar

Trial IDs

Primary ID 4P-16-3
Secondary IDs NCI-2016-00814
Clinicaltrials.gov ID NCT02809690