Page 12 - 2020 ASCO-GU Canadian Ambassador Program
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METHODS: STUDY DESIGN
• Phase 2/3, open-label, prospective, controlled pivotal study
• 10 sites in Canada (n=2) and the US (n=8)
• Central imaging core labs
• 3 central and independent PSMA PET/CT readers blinded to all clinical
information (including baseline conventional imaging, PSA and local
histopathology results)
• 1 conventional imaging central reader blinded to all clinical information and
PSMA scans and results
• Objective: To prospectively evaluate diagnostic performance of
18 F-DCFPyL PET/CT imaging in initial staging and detection of
recurrent or metastatic PCa based on blinded central reads vs
histology (reference standard)
