18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer
Primary Purpose
Prostate Neoplasm
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CAT
18F-FMAU
Laboratory Biomarker Analysis
Multiparametric Magnetic Resonance Imaging
Positron Emission Tomography
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Neoplasm
Eligibility Criteria
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
Sites / Locations
- USC / Norris Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (18F-FMAU PET/CT)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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.
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
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.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02809690
First Posted
June 19, 2016
Last Updated
September 3, 2023
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT02809690
Brief Title
18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer
Official Title
Pilot Feasibility Study of 18F-FMAU PET for Diagnosing and Characterizing Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 12, 2016 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (18F-FMAU PET/CT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CAT
Other Intervention Name(s)
CAT Scan, Computed Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo 18F-FMAU PET/CT
Intervention Type
Drug
Intervention Name(s)
18F-FMAU
Other Intervention Name(s)
Fluorine F 18 d-FMAU, 2'-deoxy-2'-[18F]fluoro-5-methyl-1-beta-D-arabinofuranosyluracil
Intervention Description
Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Multiparametric Magnetic Resonance Imaging
Other Intervention Name(s)
Multiparametric MRI
Intervention Description
Undergo mpMRI
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo 18F-FMAU PET/CT
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Undergo TRUS-guided biopsy
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 1 year
Title
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
Description
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.
Time Frame
Up to 1 year
Title
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
Description
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.
Time Frame
Up to 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossein Jadvar, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer
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