Table 1.
Patients’ characteristics and univariate association of individual variables with clinical end points.
| Parameter | Discovery Cohort (n = 80) | Validation Cohort (n = 209) | Complete Cohort (n = 289) | Clinical end Point: PCa P; Relative Risk (95%CI) |
Clinical end Point: Significant PCa P; Relative Risk (95%CI) |
|
|---|---|---|---|---|---|---|
| Patient age; median (IQR) | 66 (59.5–72.25) | 65 (60–71) | 66 (60–72) | <0.01 1.08 (1.05–1.21) |
<0.01 1.08 (1.05–1.12) |
|
| Pre-biopsy PSA level (ng/mL; median, IQR) | 8.2 (6.8–12.5) | 8.2 (6.0–13.2) | 8.19 (6.1–13.1) | <0.01 1.06 (1.03–1.07) |
<0.01 1.08 (1.04–1.13) |
|
| Previous biopsy; N (%) | 0.35 1.28 (0.76–2.17) |
0.22 1.39 (0.82–2.35) |
||||
| No | 34 (42.5) | 44 (21.0) | 78 (27.0) | |||
| Yes | 46 (57.5) | 165 (79.0) | 211 (73.0) | |||
| Highest PI-RADS score; N (%) | <0.01 2.07 (1.55–2.79) |
<0.01 2.39 (1.76–3.33) |
||||
| 1 | 1 (1.3) | 0 (0) | 1 (0.4) | |||
| 2 | 0 (0) | 24 (11.5) | 24 (8.3) | |||
| 3 | 8 (10.0) | 57 (27.3) | 65 (22.5) | |||
| 4 | 49 (61.2) | 84 (40.2) | 133 (46.0) | |||
| 5 | 22 (27.5) | 44 (21.0) | 66 (22.8) | |||
| Biopsy Gleason score (GS); N (%) | n.c. | n.c. | ||||
| Tumor free | 38 (47.5) | 103 (49.3) | 141 (48.8) | |||
| 6 | 9 (11.2) | 17 (8.1) | 26 (9.0) | |||
| 7a (GS3+4) | 16 (20.0) | 49 (23.4) | 65 (22.5) | |||
| 7b (GS4+3) | 9 (11.2) | 9 (4.3) | 18 (6.2) | |||
| 8 | 2 (2.5) | 11 (5.3) | 13 (4.5) | |||
| 9 | 5 (6.3) | 20 (9.6) | 25 (8.7) | |||
| 10 | 1 (1.3) | 0 (0) | 1 (0.3) | |||
| Targeted biopsy cores; median (IQR) | 3 (2–4) | 6 (4–7) | 5 (3–6) | 0.12 0.93 (0.85–1.03) |
0.98 0.98 (0.89–1.08) |
|
| Systematic biopsy cores; median (IQR) | 9 (8–11) | 12 (12–12) | 12 (11–12) | 0.49 0.99 (0.91–1.08) |
0.80 0.99 (0.91–1.08) |
|
| Tumor status; N (%) | n.c. | n.c. | ||||
| No tumor | 36 (45.0) | 103 (49.3) | 139 (48.1) | |||
| Tumor | 44 1 (55.0) | 106 (50.7) | 150 1 (51.9) | |||
| ΔCt miR-141-3p; median (IQR) | 18.4 (15.2–18.4) | 16.7 (15.0–19.6) | 16.9 (15.1–20.3) | 0.46 1.03 (0.96–1.10) |
0.97 1.00 (0.93–1.08) |
|
| ΔCt miR-375-5p; median (IQR) | 16.5 (14.4–19.1) | 14.7 (13.4–19.2) | 15.3 (13.6–19.2) | 0.31 1.04 (0.97–1.11) |
0.92 0.99 (0.93–1.06) |
|
| ΔCt miR-21-5p; median (IQR) | 9.2 (8.8–9.8) | 7.4 (7.0–8.0) | 7.9 (7.2–8.8) | 0.74 1.03 (0.87–1.21) |
0.61 0.96 (0.80–1.13) |
|
| ΔCt miR-320b; median (IQR) | 9.8 (8.6–10.7) | 10.2 (9.8–10.7) | 10.2 (9.8–10.7) | 0.18 0.89 (0.74–1.05) |
0.18 0.88 (0.74–1.05) |
|
| ΔCt miR-210-3p; median (IQR) | 12.8 (12.3–14.8) | 12.7 (11.9–13.7) | 12.7 (12.1–13.8) | 0.36 0.97 (0.89–1.04) |
0.22 0.95 (0.88–1.03) |
|
| ΔCt let-7c-5p; median (IQR) | 11.1 (10.7–11.5) | 11.7 (11.1–12.5) | 11.5 (11.0–12.2) | 0.14 1.12 (0.97–1.32) |
0.39 1.07 (0.92–1.23) |
|
| ΔCt miR-486-5p; median (IQR) | 3.2 (2.8–3.5) | 3.1 (2.8–3.4) | 3.1 (2.8–3.5) | 0.482 1.15 (0.78–1.79) |
0.70 0.92 (0.60–1.37) |
|
IQR—interquartile range; 1 Two patients with a tumour-free biopsy had histologically confirmed prostate cancer; n.c.—not calculated.