Table 2.
Comparison of key histopathological outcomes of MRI-detected and MRI-undetected prostate cancer in PROMIS, by both definitions of clinical significance.
| Characteristic | MRI-detected PCa (def 1) | MRI-undetected PCa (def 1) | Difference, p value | MRI-detected PCa (def 2) | MRI-undetected PCa (def 2) | Difference, p value |
|---|---|---|---|---|---|---|
| Sample size, n (%) | 213 (93) (95% CI 88–96%) | 17 (7) (95% CI 4.4–12%) | – | 287 (86) (95% CI 83–90%) | 44 (13) (95% CI 9.8–17%) | – |
| Overall Gleason | p = 0.0023 | p = 0.0007 | ||||
| 3 + 3 | 4.2% (9/213) | 5.9% (1/17) | 1.7% (95% CI –8.4% to 12%) | 5.9% (17/287) | 14% (6/44) | 8.1% (95% CI 0.02–16%) |
| 3 + 4 | 69% (148/213) | 94% (16/17) | 25% (95% CI 2.6–47%) | 75% (214/287) | 86% (38/44) | 11% (95% CI 2.5–24%) |
| 3 + 5 | 0.47% (1/213) | 0% (0/17) | – | 0.35% (1/287) | 0% (0/44) | – |
| 4 + 3 | 2.1% (44/213) | 0% (0/17) | – | 15% (44/287) | 0% (0/44) | – |
| 4 + 5 | 1.9% (4/213) | 0% (0/17) | – | 2.4% (7/287) | 0% (0/44) | – |
| 5 + 4 | 3.3% (7/213) | 0% (0/17) | – | 1.4% (4/287) | 0% (0/44) | – |
| Overall MCCL (mm) | p = 0.14 | p < 0.0001 | ||||
| 1–5 | 3.8% (8/213) | 0% (0/17) | – | 29% (82/287) | 61% (27/44) | 32% (95% CI 17–47%) |
| 6–10 | 69% (147/213) | 76% (13/17) | 7% (95% CI –16% to 30%) | 51% (147/287) | 30% (13/44) | 21% (95% CI 5.1–37%) |
| 11–15 | 26% (55/213) | 24% (4/17) | 2% (95% CI –24% to 20%) | 19% (55/287) | 9.1% (4/44) | 9.9% (95% CI 2.2–22%) |
| 16–20 | 1.4% (3/213) | 0% (0/17) | – | 1.0% (3/287) | 0% (0/44) | – |
| Median (IQR) | 9 (7–11) | 8 (6–11) | 1 (95% CI 0–2) | 8 (5–10) | 5 (4–6) | 3 (95% CI 1–3) |
CI = confidence interval; def = definition of clinical significance; IQR = interquartile range; MCCL = maximum cancer core length; MRI = magnetic resonance imaging; n = number; PCa = prostate cancer; PROMIS = Prostate Magnetic Resonance Imaging Study; TPM = template mapping.
Pathological results are from TPM biopsy.