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

  • STATUS
    Recruiting
  • End date
    Sep 12, 2023
  • participants needed
    40
  • sponsor
    University of Southern California
Updated on 23 February 2022
ct scan
cancer
MRI
prostate biopsy
prostate specific antigen
biopsy of prostate
multiparametric magnetic resonance imaging
pet/ct scan

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.

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.

Details
Condition Prostate Neoplasm
Treatment laboratory biomarker analysis, positron emission tomography, ultrasound, cat, 18F-FMAU, Multiparametric Magnetic Resonance Imaging
Clinical Study IdentifierNCT02809690
SponsorUniversity of Southern California
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion 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

Exclusion Criteria

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
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