{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"72.9","upperLimit":"89.5","value":"81.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"}],"units":"Participants"}],"title":"Central Reader 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.7","upperLimit":"90.2","value":"81.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"93"}],"units":"Participants"}],"title":"Central Reader 2"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"80.4","upperLimit":"95.3","value":"87.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"}],"units":"Participants"}],"title":"Central Reader 3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"93"}],"units":"Participants"}],"description":"Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy 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":"Recurrent or Metastatic Prostate Cancer (Cohort B)"}],"paramType":"NUMBER","populationDescription":"The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.","reportingStatus":"POSTED","timeFrame":"Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.","title":"Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}