18F-FMAU PET/CT in Diagnosing and Characterizing Prostate Cancer
NCT ID: NCT02809690
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
18 participants
INTERVENTIONAL
2016-09-12
2021-07-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
CAT
Undergo 18F-FMAU PET/CT
18F-FMAU
Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT
Laboratory Biomarker Analysis
Correlative studies
Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Positron Emission Tomography
Undergo 18F-FMAU PET/CT
Ultrasound
Undergo TRUS-guided biopsy
Interventions
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CAT
Undergo 18F-FMAU PET/CT
18F-FMAU
Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT
Laboratory Biomarker Analysis
Correlative studies
Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Positron Emission Tomography
Undergo 18F-FMAU PET/CT
Ultrasound
Undergo TRUS-guided biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Active infection (except mild upper respiratory infections)
* Active prostatitis
* Non-prostate cancers currently on treatment
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Hossein Jadvar, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2016-00814
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-16-3
Identifier Type: OTHER
Identifier Source: secondary_id
4P-16-3
Identifier Type: -
Identifier Source: org_study_id
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