Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer.
The objective of this study is to evaluate a radiolabeled urea-based small molecule
inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC) PET imaging for
detection of metastatic prostate cancer. PSMA is a well characterized histological marker of
prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to
assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative
and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic
disease detected by standard conventional imaging modalities (CIM) for prostate cancer which
includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
PET/CT detection of Metastatic Prostate Cancer
To compare the diagnostic accuracy of DCFBC PET to CIM (CT and bone scintigraphy) for detection of metastatic prostate cancer based on comparison to dynamic CIM incorporating prior and follow-up scans..
Steve Y Cho, M.D
Johns Hopkins University
United States: Food and Drug Administration
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