The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.
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Safety of FCH-PET/CT imaging as measured by the incidence of adverse events (AE)
Timeframe: 7 days
Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
Timeframe: 12 months
Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth
Timeframe: 12 months