{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"94.52","upperLimit":"99.37","value":"97.9"}]}],"title":"Central Reader 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"96.00","upperLimit":"99.96","value":"98.9"}]}],"title":"Central Reader 2"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"93.64","upperLimit":"98.99","value":"96.3"}]}],"title":"Central Reader 3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"}],"units":"Participants"}],"description":"The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.","dispersionType":"95% Confidence Interval","groups":[{"description":"High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.","id":"OG000","title":"High Risk Prostate Cancer (Cohort A)"}],"paramType":"NUMBER","populationDescription":"The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.","reportingStatus":"POSTED","timeFrame":"Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.","title":"Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}