Table 1.
Clinical characteristics of the discovery and validation study participants
| Discovery Study | Validation Study | ||||
|---|---|---|---|---|---|
| Characteristic | More aggressive† cases, N=202 (%) |
Controls, N=100 (%) |
More aggressive‡ cases, N=527 (%) |
Less aggressive cases, N=595 (%) |
Controls, N=1,167 (%) |
| Age at reference date, y | |||||
| 35 – 49 | 17 (8.4) | 8 (8.0) | 46 (8.7) | 40 (6.7) | 100 (8.6) |
| 50 – 54 | 39 (19.3) | 20 (20.0) | 68 (12.9) | 86 (14.4) | 158 (13.5) |
| 55 – 59 | 70 (34.7) | 34 (34.0) | 105 (19.9) | 159 (26.7) | 310 (26.6) |
| 60 – 64 | 76 (37.6) | 38 (38.0) | 148 (28.1) | 172 (28.9) | 295 (25.3) |
| 65 – 69 | 85 (16.1) | 68 (11.4) | 160 (13.7) | ||
| 70 – 74 | 75 (14.2) | 70 (11.8) | 144 (12.3) | ||
| Gleason score | |||||
| 2 – 4 | 3 (1.5) | 10 (1.9) | 57 (9.6) | ||
| 5 – 6 | 74 (36.6) | 76 (14.4) | 536 (90.1) | ||
| 7 = 3+4 | 79 (39.1) | 300 (56.9) | |||
| 7= 4+3 | 20 (9.9) | 56 (10.6) | |||
| 8 – 10 | 45 (22.3) | 84 (15.9) | |||
| Missing | 1 (0.5) | 1 (0.2) | 2 (0.3) | ||
| Stage | |||||
| Local | 65 (32.2) | 370 (70.2) | 595 (100) | ||
| Regional | 121 (59.9) | 140 (26.6) | |||
| Distant | 16 (7.9) | 17 (3.2) | |||
| Diagnostic PSA level, ng/mL | |||||
| < 4.0 | 18 (8.9) | 47 (8.9) | 115 (19.3) | ||
| 4.0 – 9.9 | 95 (47.0) | 279 (52.9) | 354 (59.5) | ||
| 10.0 – 19.9 | 30 (14.8) | 92 (17.5) | 69 (11.6) | ||
| 20.0 – 49.9 | 21 (10.4) | 51 (9.7) | |||
| ≥ 50.0 | 22 (10.9) | 27 (5.1) | |||
| Missing | 16 (7.9) | 31 (5.9) | 57 (9.6) | ||
| Progression/Recurrence§ | |||||
| No | 69 (34.2) | 71 (46.1) | 192 (74.7) | ||
| Yes | 97 (48.0) | 48 (31.2) | |||
| Missing | 36 (17.8) | 35 (22.7) | 65 (25.3) | ||
| Prostate cancer-specific death | |||||
| No‖ | 164 (81.2) | 496 (94.1) | 595 (100.0) | ||
| Yes | 38 (18.8) | 31 (5.9) | |||
†
More aggressive: <65 years at diagnosis, diagnostic PSA level ≥ 50ng/mL, regional/distant stage, Gleason score ≥ 7(4+3), progression/recurrence event, and/or prostate cancer-specific death;
‡
More aggressive: diagnostic PSA level ≥ 20ng/mL, regional/distant stage, Gleason score ≥ 7, progression/recurrence event, and/or prostate cancer-specific death;
§
Data available for Study I participants only;
‖
Includes patients who are alive, died of other causes or their vital status is unknown.