of the POSLUMA scan using a lesion-to-lesion co-localization method and separate consensus panel. Reference standard information for negative interpretations was not collected. At least one POSLUMA-positive lesion was detected by at least one reader in 366 patients (94%) . Reference standard information consisted of imaging only (n=297) or histopathology (n=69). As a percentage of patients with an evaluable scan, 51 % ( 9 5% CI: 46 % to 56 % ) for reader 1, 48% ( 95 % CI: 43 % to 53 % ) for reader 2, and 49% (95% CI: 44 % to 54 % ) for reader 3 had at least one matching positive region between the POSLUMA scan and the reference standard. Of all POSLUMA-positive regions, 46% (9 5% CI: 42% to 50%) for reader 1, 60% (95% CI: 55% to 66 % ) for reader 2, and 53% (95% CI: 48% to 58%) for reader 3 were categorized as positive by the reference standard. Table 7 shows patient-level results from the majority read stratified by serum PSA level. Percent PET positivity was calculated as the percentage of patients with POSLUMA-positive lesions out of all patients with an evaluable PET scan. Percent PET positivity includes true and false positives and is not a measure of diagnostic performance. Table 7: Patient-Level POSLUMA PET Results and Percent PET Positivity Stratified by Serum PSA Level in SPOTLIGHT by Majority Read (N=389)
PET Positive Patients
Percent PET Positivity [95% CI]
PSA (ng/mL)
PET Negative Patients
Histopathology
Imaging only a
N
Total
PA
NPA
PA
NPA
64 % [54,72] 76 % [64,86] 93 % [82, 99] 97 % [94, 99] 83 % [79, 86]
< 0.5
121
77
6
4
27
40
44
≥ 0.5 and < 1
67
51
7
3
24
17
16
≥ 1 and < 2
45
42
10
2
18
12
3
≥ 2
156
152
33
3
84
32
4
Total
389
322
56
12
153
101
67
PSA = prostate-specific antigen, PA = positive agreement, NPA = no positive agreement, CI = confidence interval a Imaging comprised of one or more of the following: CT, MRI, 99m Tc Bone Scan, fluciclovine F 18 PET
Variable Interpretation in Patients with Suspected Prostate Cancer Recurrence POSLUMA reader agreement was evaluated for the three central readers and 389 patients. Inter-reader Fleiss κ was 0. 41 (95% CI: 0.39-0.43). The three readers agreed on the presence or absence of positive lesions across all five evaluated regions in 118 patients (30 % unanimity) [see Warning and Precautions (5.1)]. Given the level of inter-reader agreement observed overall, POSLUMA reader agreement was further evaluated by regional subgroup . The Fleiss κ for was 0.40 ( 95% CI: 0.3 3-0.46) in the prostate/prostate bed, 0.73 (9 5% CI: 0.67-0.78) in the pelvic lymph nodes, and 0.62 (95% CI: 0. 58-0.65) across the other regions.
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Reference ID: 5180081
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