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

Sponsor
University of Southern California (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02809690
Collaborator
National Cancer Institute (NCI) (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB) (NIH)
18
1
1
96
0.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: CAT
  • Drug: 18F-FMAU
  • Other: Laboratory Biomarker Analysis
  • Procedure: Multiparametric Magnetic Resonance Imaging
  • Device: Positron Emission Tomography
  • Device: Ultrasound
Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
Actual Study Start Date :
Sep 12, 2016
Anticipated Primary Completion Date :
Sep 12, 2023
Anticipated Study Completion Date :
Sep 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (18F-FMAU PET/CT)

Patients receive radiotracer F 18 d-FMAU 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.

Device: CAT
Undergo 18F-FMAU PET/CT
Other Names:
  • CAT Scan
  • Computed Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
  • Drug: 18F-FMAU
    Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT
    Other Names:
  • Fluorine F 18 d-FMAU
  • 2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil
  • Other: Laboratory Biomarker Analysis
    Correlative studies

    Procedure: Multiparametric Magnetic Resonance Imaging
    Undergo mpMRI
    Other Names:
  • Multiparametric MRI
  • Device: Positron Emission Tomography
    Undergo 18F-FMAU PET/CT
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • Device: Ultrasound
    Undergo TRUS-guided biopsy

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of men for whom biopsy cores taken based only on the 18F-FMAU PET/CT results would have yielded the same overall diagnosis as the standard TRUS-guided core or the mpMRI-directed prostate biopsies [Up to 1 year]

      Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships.

    2. Proportion of men for whom the 18F-FMAU PET/CT identified all lesions that were found to have cancer based on the standard TRUS-guided and the mpMRI directed core prostate biopsies [Up to 1 year]

      Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships.

    3. Proportion of men who completed both imaging procedures and for whom biopsy cores taken based only on the fluorine 18F-FMAU PET/CT results would have yielded the same overall diagnosis as the standard TRUS-guided core prostate biopsies [Up to 1 year]

      Standard descriptive methods will be used to summarize the data collected: means, standard deviations, ranges, and confidence intervals (or medians, quartiles), contingency tables, histograms, correlation coefficients (Pearson or Spearman) and scatter plots. The scatter plots and correlations between each of the histopathology parameters and the imaging parameters will be examined to better understand the relationships.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)
    • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    Investigators

    • Principal Investigator: Hossein Jadvar, MD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT02809690
    Other Study ID Numbers:
    • 4P-16-3
    • NCI-2016-00814
    • 4P-16-3
    • P30CA014089
    • R21EB017568
    First Posted:
    Jun 22, 2016
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2022