Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer · Source last updated 2021-08-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken
What was measured
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.
Analysis population: 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.
Groups in this outcome
Cohort A - Conventional Imaging
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.
Cohort A - 18F-DCFPyL PET/CT: Reader 1
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.
Cohort A - 18F-DCFPyL PET/CT: Reader 2
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.
Cohort A - 18F-DCFPyL PET/CT: Reader 3
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.
Cohort B - Conventional Imaging
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.
Cohort B - 18F-DCFPyL PET/CT: Reader 1
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.
Cohort B - 18F-DCFPyL PET/CT: Reader 2
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.
Cohort B - 18F-DCFPyL PET/CT: Reader 3
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Cohort A - Conventional Imaging
252
Cohort A - 18F-DCFPyL PET/CT: Reader 1
252
Cohort A - 18F-DCFPyL PET/CT: Reader 2
252
Cohort A - 18F-DCFPyL PET/CT: Reader 3
252
Cohort B - Conventional Imaging
92
Cohort B - 18F-DCFPyL PET/CT: Reader 1
93
Cohort B - 18F-DCFPyL PET/CT: Reader 2
93
Cohort B - 18F-DCFPyL PET/CT: Reader 3
93
Reported measurements
Tissue Site: Bone
Analysis denominator · Participants
Group
Source count
Cohort A - Conventional Imaging
251
Cohort A - 18F-DCFPyL PET/CT: Reader 1
252
Cohort A - 18F-DCFPyL PET/CT: Reader 2
252
Cohort A - 18F-DCFPyL PET/CT: Reader 3
252
Cohort B - Conventional Imaging
92
Cohort B - 18F-DCFPyL PET/CT: Reader 1
93
Cohort B - 18F-DCFPyL PET/CT: Reader 2
93
Cohort B - 18F-DCFPyL PET/CT: Reader 3
93
Number of Lesions: 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
239
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
234
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
247
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
237
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
37
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
22
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
28
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
23
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
9
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
17
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
4
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
13
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
20
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
21
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
24
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
22
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
1
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
1
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
2
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
8
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
10
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
4
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
10
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 5-6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
2
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
1
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
3
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
5
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
2
Not reported
Not reported
Not reported
Not reported
Number of Lesions: >6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
1
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
26
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
37
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
32
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
36
Not reported
Not reported
Not reported
Not reported
Tissue Site: Visceral/Soft Tissue
Analysis denominator · Participants
Group
Source count
Cohort A - Conventional Imaging
251
Cohort A - 18F-DCFPyL PET/CT: Reader 1
252
Cohort A - 18F-DCFPyL PET/CT: Reader 2
252
Cohort A - 18F-DCFPyL PET/CT: Reader 3
252
Cohort B - Conventional Imaging
92
Cohort B - 18F-DCFPyL PET/CT: Reader 1
93
Cohort B - 18F-DCFPyL PET/CT: Reader 2
93
Cohort B - 18F-DCFPyL PET/CT: Reader 3
93
Number of Lesions: 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
233
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
241
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
249
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
240
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
72
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
71
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
73
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
64
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
16
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
11
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
3
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
12
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
13
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
15
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
14
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
20
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
1
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
3
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
2
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
1
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
4
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 5-6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
2
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
1
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
2
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Number of Lesions: >6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
1
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
2
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
4
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
3
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
5
Not reported
Not reported
Not reported
Not reported
Tissue Site: Lymph Nodes
Analysis denominator · Participants
Group
Source count
Cohort A - Conventional Imaging
251
Cohort A - 18F-DCFPyL PET/CT: Reader 1
252
Cohort A - 18F-DCFPyL PET/CT: Reader 2
252
Cohort A - 18F-DCFPyL PET/CT: Reader 3
252
Cohort B - Conventional Imaging
92
Cohort B - 18F-DCFPyL PET/CT: Reader 1
93
Cohort B - 18F-DCFPyL PET/CT: Reader 2
93
Cohort B - 18F-DCFPyL PET/CT: Reader 3
93
Number of Lesions: 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
157
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
216
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
226
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
218
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
37
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
38
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
37
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
38
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
39
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
28
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
19
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
25
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
18
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
11
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
16
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
10
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
10
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
5
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
4
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
5
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
8
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
7
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
13
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
10
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 5-6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
16
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
3
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
3
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
3
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
7
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
8
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
4
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
8
Not reported
Not reported
Not reported
Not reported
Number of Lesions: >6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
29
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
1
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
22
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
29
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
23
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
27
Not reported
Not reported
Not reported
Not reported
Tissue Site: Prostate Gland
Analysis denominator · Participants
Group
Source count
Cohort A - Conventional Imaging
250
Cohort A - 18F-DCFPyL PET/CT: Reader 1
252
Cohort A - 18F-DCFPyL PET/CT: Reader 2
252
Cohort A - 18F-DCFPyL PET/CT: Reader 3
252
Cohort B - Conventional Imaging
91
Cohort B - 18F-DCFPyL PET/CT: Reader 1
93
Cohort B - 18F-DCFPyL PET/CT: Reader 2
93
Cohort B - 18F-DCFPyL PET/CT: Reader 3
93
Number of Lesions: 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
162
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
5
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
5
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
14
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
79
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
64
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
69
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
63
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
88
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
199
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
209
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
204
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
12
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
20
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
22
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
30
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
38
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
33
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
31
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
6
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
1
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 5-6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
10
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
4
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
3
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
1
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
0
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Number of Lesions: >6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
0
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
1
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
0
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
2
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
1
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
0
Not reported
Not reported
Not reported
Not reported
Tissue Site: All
Analysis denominator · Participants
Group
Source count
Cohort A - Conventional Imaging
252
Cohort A - 18F-DCFPyL PET/CT: Reader 1
252
Cohort A - 18F-DCFPyL PET/CT: Reader 2
252
Cohort A - 18F-DCFPyL PET/CT: Reader 3
252
Cohort B - Conventional Imaging
92
Cohort B - 18F-DCFPyL PET/CT: Reader 1
93
Cohort B - 18F-DCFPyL PET/CT: Reader 2
93
Cohort B - 18F-DCFPyL PET/CT: Reader 3
93
Number of Lesions: 0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
109
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
3
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
5
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
14
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
14
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
3
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
11
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
7
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 1-2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
75
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
174
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
196
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
175
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
11
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
15
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
17
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
14
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 3-4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
16
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
55
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
38
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
47
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
8
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
10
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
9
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
8
Not reported
Not reported
Not reported
Not reported
Number of Lesions: 5-6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
17
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
9
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
10
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
11
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
9
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
9
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
10
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
11
Not reported
Not reported
Not reported
Not reported
Number of Lesions: >6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort A - Conventional Imaging
35
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 1
11
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 2
3
Not reported
Not reported
Not reported
Not reported
Cohort A - 18F-DCFPyL PET/CT: Reader 3
5
Not reported
Not reported
Not reported
Not reported
Cohort B - Conventional Imaging
50
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 1
56
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 2
46
Not reported
Not reported
Not reported
Not reported
Cohort B - 18F-DCFPyL PET/CT: Reader 3
53
Not reported
Not reported
Not reported
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
group Description
Tissue Site: Bone
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1097
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.1087
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.1949
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.1315
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG004
OG006
non Inferiority Type
SUPERIORITY
p Value
0.1977
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG004
OG007
non Inferiority Type
SUPERIORITY
p Value
0.2149
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2582
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0009
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3588
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.8791
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG004
OG006
non Inferiority Type
SUPERIORITY
p Value
0.9457
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG004
OG007
non Inferiority Type
SUPERIORITY
p Value
0.2705
statistical Method
Fisher Exact
Complete source fields
analyses
group Description
Tissue Site: Bone
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1097
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.1087
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.1949
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.1315
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG004
OG006
non Inferiority Type
SUPERIORITY
p Value
0.1977
statistical Method
Fisher Exact
group Description
Tissue Site: Bone
group Ids
OG004
OG007
non Inferiority Type
SUPERIORITY
p Value
0.2149
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2582
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0009
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG000
OG003
non Inferiority Type
SUPERIORITY
p Value
0.3588
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.8791
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG004
OG006
non Inferiority Type
SUPERIORITY
p Value
0.9457
statistical Method
Fisher Exact
group Description
Tissue Site: Visceral/Soft tissue
group Ids
OG004
OG007
non Inferiority Type
SUPERIORITY
p Value
0.2705
statistical Method
Fisher Exact
classes
categories
measurements
group Id
OG000
value
239
group Id
OG001
value
234
group Id
OG002
value
247
group Id
OG003
value
237
group Id
OG004
value
37
group Id
OG005
value
22
group Id
OG006
value
28
group Id
OG007
value
23
title
Number of Lesions: 0
measurements
group Id
OG000
value
9
group Id
OG001
value
17
group Id
OG002
value
4
group Id
OG003
value
13
group Id
OG004
value
20
group Id
OG005
value
21
group Id
OG006
value
24
group Id
OG007
value
22
title
Number of Lesions: 1-2
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
8
group Id
OG005
value
10
group Id
OG006
value
4
group Id
OG007
value
10
title
Number of Lesions: 3-4
measurements
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
3
group Id
OG006
value
5
group Id
OG007
value
2
title
Number of Lesions: 5-6
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
26
group Id
OG005
value
37
group Id
OG006
value
32
group Id
OG007
value
36
title
Number of Lesions: >6
denoms
counts
group Id
OG000
value
251
group Id
OG001
value
252
group Id
OG002
value
252
group Id
OG003
value
252
group Id
OG004
value
92
group Id
OG005
value
93
group Id
OG006
value
93
group Id
OG007
value
93
units
Participants
title
Tissue Site: Bone
categories
measurements
group Id
OG000
value
233
group Id
OG001
value
241
group Id
OG002
value
249
group Id
OG003
value
240
group Id
OG004
value
72
group Id
OG005
value
71
group Id
OG006
value
73
group Id
OG007
value
64
title
Number of Lesions: 0
measurements
group Id
OG000
value
16
group Id
OG001
value
11
group Id
OG002
value
3
group Id
OG003
value
12
group Id
OG004
value
13
group Id
OG005
value
15
group Id
OG006
value
14
group Id
OG007
value
20
title
Number of Lesions: 1-2
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
3
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
4
title
Number of Lesions: 3-4
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
1
group Id
OG006
value
2
group Id
OG007
value
0
title
Number of Lesions: 5-6
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
4
group Id
OG006
value
3
group Id
OG007
value
5
title
Number of Lesions: >6
denoms
counts
group Id
OG000
value
251
group Id
OG001
value
252
group Id
OG002
value
252
group Id
OG003
value
252
group Id
OG004
value
92
group Id
OG005
value
93
group Id
OG006
value
93
group Id
OG007
value
93
units
Participants
title
Tissue Site: Visceral/Soft Tissue
categories
measurements
group Id
OG000
value
157
group Id
OG001
value
216
group Id
OG002
value
226
group Id
OG003
value
218
group Id
OG004
value
37
group Id
OG005
value
38
group Id
OG006
value
37
group Id
OG007
value
38
title
Number of Lesions: 0
measurements
group Id
OG000
value
39
group Id
OG001
value
28
group Id
OG002
value
19
group Id
OG003
value
25
group Id
OG004
value
18
group Id
OG005
value
11
group Id
OG006
value
16
group Id
OG007
value
10
title
Number of Lesions: 1-2
measurements
group Id
OG000
value
10
group Id
OG001
value
5
group Id
OG002
value
4
group Id
OG003
value
5
group Id
OG004
value
8
group Id
OG005
value
7
group Id
OG006
value
13
group Id
OG007
value
10
title
Number of Lesions: 3-4
measurements
group Id
OG000
value
16
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
7
group Id
OG005
value
8
group Id
OG006
value
4
group Id
OG007
value
8
title
Number of Lesions: 5-6
measurements
group Id
OG000
value
29
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
22
group Id
OG005
value
29
group Id
OG006
value
23
group Id
OG007
value
27
title
Number of Lesions: >6
denoms
counts
group Id
OG000
value
251
group Id
OG001
value
252
group Id
OG002
value
252
group Id
OG003
value
252
group Id
OG004
value
92
group Id
OG005
value
93
group Id
OG006
value
93
group Id
OG007
value
93
units
Participants
title
Tissue Site: Lymph Nodes
categories
measurements
group Id
OG000
value
162
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
14
group Id
OG004
value
79
group Id
OG005
value
64
group Id
OG006
value
69
group Id
OG007
value
63
title
Number of Lesions: 0
measurements
group Id
OG000
value
88
group Id
OG001
value
199
group Id
OG002
value
209
group Id
OG003
value
204
group Id
OG004
value
12
group Id
OG005
value
20
group Id
OG006
value
22
group Id
OG007
value
30
title
Number of Lesions: 1-2
measurements
group Id
OG000
value
0
group Id
OG001
value
38
group Id
OG002
value
33
group Id
OG003
value
31
group Id
OG004
value
0
group Id
OG005
value
6
group Id
OG006
value
1
group Id
OG007
value
0
title
Number of Lesions: 3-4
measurements
group Id
OG000
value
0
group Id
OG001
value
10
group Id
OG002
value
4
group Id
OG003
value
3
group Id
OG004
value
0
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
0
title
Number of Lesions: 5-6
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
0
title
Number of Lesions: >6
denoms
counts
group Id
OG000
value
250
group Id
OG001
value
252
group Id
OG002
value
252
group Id
OG003
value
252
group Id
OG004
value
91
group Id
OG005
value
93
group Id
OG006
value
93
group Id
OG007
value
93
units
Participants
title
Tissue Site: Prostate Gland
categories
measurements
group Id
OG000
value
109
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
14
group Id
OG004
value
14
group Id
OG005
value
3
group Id
OG006
value
11
group Id
OG007
value
7
title
Number of Lesions: 0
measurements
group Id
OG000
value
75
group Id
OG001
value
174
group Id
OG002
value
196
group Id
OG003
value
175
group Id
OG004
value
11
group Id
OG005
value
15
group Id
OG006
value
17
group Id
OG007
value
14
title
Number of Lesions: 1-2
measurements
group Id
OG000
value
16
group Id
OG001
value
55
group Id
OG002
value
38
group Id
OG003
value
47
group Id
OG004
value
8
group Id
OG005
value
10
group Id
OG006
value
9
group Id
OG007
value
8
title
Number of Lesions: 3-4
measurements
group Id
OG000
value
17
group Id
OG001
value
9
group Id
OG002
value
10
group Id
OG003
value
11
group Id
OG004
value
9
group Id
OG005
value
9
group Id
OG006
value
10
group Id
OG007
value
11
title
Number of Lesions: 5-6
measurements
group Id
OG000
value
35
group Id
OG001
value
11
group Id
OG002
value
3
group Id
OG003
value
5
group Id
OG004
value
50
group Id
OG005
value
56
group Id
OG006
value
46
group Id
OG007
value
53
title
Number of Lesions: >6
denoms
counts
group Id
OG000
value
252
group Id
OG001
value
252
group Id
OG002
value
252
group Id
OG003
value
252
group Id
OG004
value
92
group Id
OG005
value
93
group Id
OG006
value
93
group Id
OG007
value
93
units
Participants
title
Tissue Site: All
denoms
counts
group Id
OG000
value
252
group Id
OG001
value
252
group Id
OG002
value
252
group Id
OG003
value
252
group Id
OG004
value
92
group Id
OG005
value
93
group Id
OG006
value
93
group Id
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
param Type
COUNT_OF_PARTICIPANTS
population Description
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.
reporting Status
POSTED
time Frame
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
Triangle