False Positive True Negative False Negative Sensitivity, (%) [95% CI] Specificity, (%) [ 95% CI ]
16
14
7
210
212
219
49
51
54
3 0% [20, 42] 93 % [89, 96] 57 % [40, 73] 81% [76, 86]
27% [17, 39] 94 % [90, 97] 58 % [39, 75] 81 % [75, 85]
23 % [14, 35] 97 % [94, 99] 70 % [47, 87] 80 % [75, 85]
Positive Predictive Value , (%) [95% CI] Negative Predictive Value , (%) [95% CI]
CI= confidence interval In exploratory analyses, there were numerical trends towards higher sensitivity among patients with PSA greater than or equal to the median value (8.4 ng/mL) and among patients with high-risk or very high-risk categorization. POSLUMA-positive lesions outside of the prostate gland and pelvic lymph nodes (M1) were also evaluated. As a percentage of the 352 patients with an evaluable POSLUMA scan and of the 61 patients with at least one POSLUMA positive M1 lesion, 10 % ( 95% CI: 7 % to 13 %) and 56% ( 95% CI: 42% to 68%) , respectively, had at least one matching positive M1 lesion between the POSLUMA majority read and a reference standard consisting of other imaging evaluated by a separate consensus panel or histopathology. 14.2 Imaging for Suspected Recurrence of Prostate Cancer The safety and efficacy of POSLUMA were evaluated in SPOTLIGHT (NCT04186845), a prospective, multicenter, open-label, single-arm study in patients with biochemical evidence of recurrent prostate cancer. The study enrolled 391 patients with suspected recurrence defined by either serum PSA of at least 0.2 ng/mL after radical prostatectomy (with confirmatory PSA level also at least 0.2 ng/mL) or by an increase in serum PSA of at least 2 ng/mL above the nadir after other therapies. All patients received a single dose of POSLUMA with an administered radioactivity (mean ± SD) of 306 ± 22 MBq (8.27 ±0.61 mCi), followed by PET/CT scan from mid-thigh to base of the skull. Three central readers blinded to clinical information independently interpreted each scan by region for the presence and location of lesions considered positive for prostate cancer [see Dosage and Administration (2.5)] . The regions interpreted were grouped into three for primary analysis: prostate/prostate bed; pelvic lymph nodes; and other (including extra-pelvic lymph nodes, bone, and soft tissue/parenchyma). A total of 389 patients had an evaluable POSLUMA PET scan. The mean age was 68 years (range: 43 to 86 years); distribution by r ace was 75% White, 16% Black or African American, 4 % other, and 5% unreported; and distribution by ethnici ty 5% w as Hispanic/Lati no, 87% non - Hispanic/Latino, and 8% unreported. The median baseline serum PSA level was 1.1 ng/mL with 60 % of patients having a baseline PSA <2.0 ng/mL. Prior treatment included radical prostatectomy in 79 % of the patients. POSLUMA-positive interpretations were compared to a reference standard of either histopathology or other imaging (CT, MRI, Technetium 99m bone scan, or fluciclovine F 18 PET) obtained within 90 days
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Reference ID: 5180081
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