Table 4 Comparison of single features, risk calculators, and ClarityDX Prostate for predicting grade group ≥2 prostate cancer in the validation cohort
GG ≤ 1 PCa | GG ≥ 2 PCa | p-value | ROC AUC (CI) | Cutoff | Sensitivity, % (CI) | Specificity, % (CI) | PPV, % (CI) | NPV, % (CI) | |
|---|---|---|---|---|---|---|---|---|---|
Patients, n | 702 (56%) | 555 (44%) | |||||||
Prior negative biopsy, n (%) | 158 (23%) | 68 (12%) | <0.0001 | 0.55 (0.53–0.57) | 88 (85–90) | 23 (20–26) | 47 (44 –50) | 70 (64–76) | |
DRE, n (% abnormal) | 73 (10%) | 177 (32%) | <0.0001 | 0.66 (0.63–0.69) | 46 (40–50) | 86 (83–89) | 71 (65–76) | 68 (64–71) | |
Age, yr, median (IQR) | 62 (56–66) | 65 (61–70) | <0.0001 | 0.65 (0.62–0.68) | ≥55 | 94 (92–96) | 16 (14–19) | 47 (44–50) | 78 (70–84) |
PSA, ng/ml, median (IQR) | 6.2 (4.8–8.4) | 9.1 (6.5–15) | <0.0001 | 0.72 (0.69–0.74) | ≥4.0 | 95 (95–97) | 12 (12–15) | 46 (41–48) | 78 (74–82) |
% Free PSA, median (IQR) | 16 (12–21) | 11 (8–15) | <0.0001 | 0.72 (0.69–0.75) | <25.1 | 95 (92–96) | 11 (8.8–13) | 46 (43–49) | 72 (63–80) |
ERSPC-3, median (IQR) | 6.0 (3.0–12) | 19 (7.0–41) | <0.0001 | 0.74 (0.71–0.77) | ≥1.5 | 94 (92–96) | 15 (12–17) | 47 (44–50) | 76 (68–82) |
PCPTRC, median (IQR) | 9.0 (6.0–12) | 14 (10–22) | <0.0001 | 0.75 (0.72–0.78) | ≥5.5 | 94 (92–96) | 23 (20–26) | 49 (46–52) | 84 (78–88) |
PBCG, median (IQR) | 24 (16–37) | 46 (31–64) | <0.0001 | 0.77 (0.74–0.79) | ≥14.4 | 95 (92–96) | 21 (18–24) | 49 (46–52) | 83 (77–88) |
ClarityDX Prostate, median (IQR) | 32 (22–47) | 63 (44–82) | <0.0001 | 0.82 (0.79–0.84) | ≥25 | 95 (94–97) | 35 (32–39) | 54 (51–57) | 91 (87–94) |