Table 1. Baseline characteristics.
| Abiraterone trial | Abiraterone and enzalutamide trial | ||||
|---|---|---|---|---|---|
| Standard of care (n=502) |
Standard of care plus abiraterone (n=501) |
Standard of care (n=454) |
Standard of care plus enzalutamide and abiraterone (n=462) |
||
| Age, years | |||||
| Median | 67 (62–72) | 67 (62–71) | 68 (64–73) | 69 (63–74) | |
| Min-max | 39–84 | 42–85 | 37–83 | 48–84 | |
| Prostate-specific antigen before androgen deprivation therapy, ng/mL | |||||
| Median | 97 (26–358) | 96 (29–371) | 97 (25–319) | 85 (26–337) | |
| Min-max | 1–10530 | 0–21460 | 0–20590 | 1–6881 | |
| Time from diagnosis to randomisation, days | |||||
| Median | 71 (51–95) | 77 (54–97) | 75 (56–99) | 78 (59–100) | |
| Min-max | 0–4866 | 3–5384 | 4–5346 | 2–4676 | |
| T stage | |||||
| T0–T2 | 56 (11%) | 51 (10%) | 42 (9%) | 47 (10%) | |
| T3 | 270 (54%) | 289 (58%) | 252 (56%) | 273 (59%) | |
| T4 | 137 (27%) | 118 (24%) | 117 (26%) | 95 (21%) | |
| Tx | 39 (8%) | 43 (9%) | 43 (9%) | 47 (10%) | |
| N stage (pelvic nodes) | |||||
| N0 | 175 (35%) | 167 (33%) | 150 (33%) | 157 (34%) | |
| N+ | 291 (58%) | 293 (58%) | 278 (61%) | 278 (60%) | |
| NX | 36 (7%) | 41 (8%) | 26 (6%) | 27 (6%) | |
| Metastatic volume | |||||
| Low | 204 (41%) | 222 (44%) | 162 (36%) | 195 (42%) | |
| High | 271 (54%) | 253 (51%) | 209 (46%) | 196 (42%) | |
| Missing | 27 (5%) | 26 (5%) | 83 (18%) | 71 (15%) | |
| Gleason Score | |||||
| ≤7 | 118 (24%) | 115 (23%) | 92 (20%) | 79 (17%) | |
| 8 | 106 (21%) | 117 (23%) | 88 (19%) | 94 (20%) | |
| 9 | 245 (49%) | 231 (46%) | 239 (53%) | 258 (56%) | |
| 10 | 23 (5%) | 18 (4%) | 18 (4%) | 17 (4%) | |
| Unknown | 10 (2%) | 20 (4%) | 17 (4%) | 14 (3%) | |
| WHO performance status | |||||
| 0 | 370 (74%) | 376 (75%) | 315 (69%) | 325 (70%) | |
| 1 | 125 (25%) | 118 (24%) | 134 (30%) | 129 (28%) | |
| 2 | 7 (1%) | 7 (1%) | 5 (1%) | 8 (2%) | |
| Pain from prostate cancer | |||||
| Absent | 396 (79%) | 389 (78%) | 374 (82%) | 368 (80%) | |
| Present | 102 (20%) | 107 (21%) | 78 (17%) | 86 (19%) | |
| Unknown | 4 (1%) | 5 (1%) | 2 (<1%) | 8 (2%) | |
| Aspirin use | |||||
| No | 412 (82%) | 411 (82%) | 374 (82%) | 377 (82%) | |
| Yes | 90 (18%) | 90 (18%) | 80 (18%) | 85 (18%) | |
| Non-steroidal anti-inflammatory drug use | |||||
| No | 448 (89%) | 449 (90%) | 411 (91%) | 419 (91%) | |
| Yes | 54 (11%) | 52 (10%) | 43 (9%) | 43 (9%) | |
| Planned or current hormone therapy | |||||
| Orchiectomy | 3 (1%) | 3 (1%) | 0 | 1 (<1%) | |
| Luteinising hormone-releasing hormone agonists or antagonists | 497 (99%) | 498 (99%) | 452 (100%) | 460 (100%) | |
| Bicalutamide | 1 (<1%) | 0 | 1 (<1%) | 1 (<1%) | |
| Maximum androgen blockade | 1 (<1%) | 0 | 1 (<1%) | 0 | |
| Palliative radiotherapy planned as standard of care | |||||
| No | 479 (95%) | 480 (96%) | 454 (100%) | 460 (100%) | |
| Yes | 23 (5%) | 21 (4%) | 0 | 2 (<1%) | |
| Previous treatment to prostate | |||||
| No | 475 (95%) | 466 (93%) | 424 (93%) | 432 (94%) | |
| Yes | 27 (5%) | 35 (7%) | 30 (7%) | 30 (6%) | |
| Docetaxel planned as standard of care | |||||
| No | 0 | 0 | 34 (7%) | 34 (7%) | |
| Yes | 0 | 0 | 39 (9%) | 41 (9%) | |
| Not applicable (before change in standard of care) | 502 (100%) | 501 (100%) | 381 (84%) | 387 (84%) | |
Data are median (IQR), min-max, or n (%). Abiraterone refers to abiraterone acetate and prednisolone. Additional characteristics are shown in the appendix (p 2).