Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
PET detection of primary prostate cancer
To compare the detection and sextant localization of primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score > 4+3=7).
Steve Y. Cho, MD
Johns Hopkins University
United States: Food and Drug Administration
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