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A Phase 3, Multi-Center, Open-Label Study to Assess the DiagNostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men with Suspected Recurrence of PrOstate CanceR (CONDOR)
To determine the Correct Localization Rate (CLR) of 18F-DCFPyL PET/CT imaging in the detection of recurrent prostate cancer at the subject level. To assess the impact of 18F-DCFPyL PET/CT disease detection on patients clinical management plans. To evaluate the safety and tolerability of 18F-DCFPyL. To determine detection rates of disease sites with 18F-DCFPyL PET/CT by region (prostatic, pelvic, extra-pelvic) and baseline PSA. To determine the Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT imaging in the detection of recurrent disease in the prostatic, pelvic, and extra-pelvic regions.