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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809690
Recruitment Status : Suspended (Drug availability issue)
First Posted : June 22, 2016
Last Update Posted : April 29, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
University of Southern California

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
Prostate Neoplasm 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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : September 12, 2016
Estimated Primary Completion Date : September 12, 2020
Estimated Study Completion Date : September 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809690


Locations
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United States, California
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
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Principal Investigator: Hossein Jadvar University of Southern California
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02809690    
Other Study ID Numbers: 4P-16-3
NCI-2016-00814 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4P-16-3 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
R21EB017568 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Clevudine
Antiviral Agents
Anti-Infective Agents