Table 4.
Performance comparisons of GAPT-E to SOC at 90% fixed sensitivity in the training cohort – Cancer vs. No Cancer and High Grade Cancer (GS >=7) vs. GS<=6, No Cancer in the validation cohort
| Cancer vs. No Cancer in the validation cohort | ||||
| Sensitivity % (95% CI) | Specificity % (95% CI) | NPV % (95% CI) | PPV% (95% CI) | |
| *SOC | 86.9 (79.0–92.7) | 15.4 (5.86–30.5) | 30.0 (11.9–54.3) | 73.8 (65.2–81.2) |
| PT-E | 54.2 (44.3–63.9) | 69.2 (52.4–83.0) | 35.5 (24.8–47.3) | 82.9 (72.0–90.8) |
| GAPT-E | 57.0 (47.1–66.5) | 66.7 (44.6–76.6) | 36.1 (25.1–48.3) | 82.4 (71.8–90.3) |
| Improvement: GAPT-E vs. PT-E | 2.5 | 0.6 | −0.5 | |
| Improvement: GAPT-E vs. SOC | 51.3 | 6.1 | 8.6 | |
| High Grade Cancer (GS >=7) vs. GS<=6, No Cancer in the validation cohort | ||||
| Sensitivity % (95% CI) | Specificity % (95% CI) | NPV % (95% CI) | PPV% (95% CI) | |
| *SOC | 84.3 (74.7–91.4) | 17.5 (9.1–29.1) | 45.8 (25.6–67.2) | 57.4 (48.1–66.3) |
| PT-E | 55.4 (44.1–66.3) | 61.9 (48.8–73.9) | 51.3 (39.6–63.0) | 65.7 (53.4–76.7) |
| GAPT-E | 47.0 (35.9–58.3) | 92.1 (82.4–97.4) | 56.9 (46.7–66.6) | 88.6 (75.4–96.2) |
| Improvement: GAPT-E vs. PT-E | 30.2 | 5.6 | 22.9 | |
| Improvement: GAPT-E vs. SOC | 74.6 | 11.1 | 31.2 | |
GAPT-E = urine EV GATA2, PCA3, and TMPRSS2-ERG; PT-E = urine EV PCA3, and TMPRSS2-ERG; SOC = standard of care; GS = Gleason score; NPV = negative predictive value; PPV = positive predictive value; CI = confidence interval
*
In the validation set SOC includes race, family history, PSA, and age