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1-2"},{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"55"},{"groupId":"OG002","value":"38"},{"groupId":"OG003","value":"47"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"10"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"8"}],"title":"Number of Lesions: 3-4"},{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"11"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"11"}],"title":"Number of Lesions: 5-6"},{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"50"},{"groupId":"OG005","value":"56"},{"groupId":"OG006","value":"46"},{"groupId":"OG007","value":"53"}],"title":"Number of Lesions: >6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"252"},{"groupId":"OG002","value":"252"},{"groupId":"OG003","value":"252"},{"groupId":"OG004","value":"92"},{"groupId":"OG005","value":"93"},{"groupId":"OG006","value":"93"},{"groupId":"OG007","value":"93"}],"units":"Participants"}],"title":"Tissue Site: All"}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"252"},{"groupId":"OG002","value":"252"},{"groupId":"OG003","value":"252"},{"groupId":"OG004","value":"92"},{"groupId":"OG005","value":"93"},{"groupId":"OG006","value":"93"},{"groupId":"OG007","value":"93"}],"units":"Participants"}],"description":"The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.","groups":[{"description":"High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.","id":"OG000","title":"Cohort A - Conventional Imaging"},{"description":"One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.","id":"OG001","title":"Cohort A - 18F-DCFPyL PET/CT: Reader 1"},{"description":"One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.","id":"OG002","title":"Cohort A - 18F-DCFPyL PET/CT: Reader 2"},{"description":"One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.","id":"OG003","title":"Cohort A - 18F-DCFPyL PET/CT: Reader 3"},{"description":"Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.","id":"OG004","title":"Cohort B - Conventional Imaging"},{"description":"One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.","id":"OG005","title":"Cohort B - 18F-DCFPyL PET/CT: Reader 1"},{"description":"One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.","id":"OG006","title":"Cohort B - 18F-DCFPyL PET/CT: Reader 2"},{"description":"One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.","id":"OG007","title":"Cohort B - 18F-DCFPyL PET/CT: Reader 3"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Evaluable Set consisted of high risk cancer participants (Cohort A) who received 18F-DCFPyL and had a prostatectomy or lymphadenectomy, and participants with recurrent or metastatic prostate cancer (Cohort B) who received 18F-DCFPyL and had a conventional image-guided biopsy, and had an 18F-DCFPyL PET/CT imaging result and a corresponding histology result.","reportingStatus":"POSTED","timeFrame":"Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken","title":"Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging","type":"SECONDARY","unitOfMeasure":"Participants"}