Table 1. Baseline patient and disease characteristics.
| Characteristic | PREVAIL (n=1,717) [6] | PREVAIL Korean (n=78) [10] | Current study (n=199) | ||
|---|---|---|---|---|---|
| ENZA (n=872) | Placebo (n=845) | ENZA (n=40) | Placebo (n=38) | ||
| Median age (y) | 72 (43–93) | 71 (42–93) | 71 (56–83) | 67 (42–85) | 74 (51-94) |
| Median body weight (kg) | 83.1 | 82.8 | 67.0 | 70.5 | 66.0 |
| Body mass index (kg/m2) | 27.5 | 27.5 | 24.4 | 25.5 | 24.2 |
| Gleason score ≥8 at initial diagnosis | 424 (50.6) | 423 (52.4) | 30 (81.1) | 31 (81.6) | 145 (81.5) |
| Missing | 34 | 37 | 3 | 21 | |
| ECOG PS grade=0 | 584 (67.0) | 585 (69.2) | 22 (55.0) | 29 (76.3) | 62 (33.3) |
| Missing | 13 | ||||
| Median PSA (ng/mL) | 54.1 | 44.2 | 25.4 | 26.2 | 51.6 |
| Median LDH (IU/L) | 185.0 | 185.0 | 191.0 | 184.5 | 333.0 |
| Prior radical prostatectomy (%) | 226 (25.9) | 225 (26.6) | 11 (27.5) | 4 (10.5) | 36 (18.2) |
| Missing | 1 | ||||
| Bone disease (%) | 741 (85.0) | 690 (81.7) | 36 (90.0) | 30 (78.9) | 160 (82.5) |
| Missing | 5 | ||||
| ≥20 bone metastases | 145 (16.6) | 150 (17.8) | Unknown | Unknown | 15 (9.9) |
| Missing | 47 | ||||
| Soft-tissue disease (lymph node, visceral, or other) | 517 (59.3) | 504 (59.6) | 22 (55.0) | 22 (57.9) | 110 (58.5) |
| Missing | 11 | ||||
| Concurrent ADT | 872 (100.0) | 845 (100.0) | 40 (100.0) | 38 (100.0) | 89 (44.9) |
| Missing | 1 | ||||
Values are presented as median (range), number only, or number (%).
ENZA, enzalutamide; ECOG PS, European Cooperative Oncology Group Performance Status; PSA, prostate-specific antigen; LDH, lactate dehydrogenase; ADT, androgen deprivation therapy.