Table 1.
Baseline characteristics
| Standard of care (n=1184) | Standard of care plus zoledronic acid (n=593) | Standard of care plus docetaxel (n=592) | Standard of care plus zoledronic acid and docetaxel (n=593) | ||
|---|---|---|---|---|---|
| Age, years | |||||
| Median (IQR) | 65 (60–70) | 66 (61–71) | 65 (61–71) | 66 (60–70) | |
| Range | 41–82 | 42–82 | 40–81 | 42–84 | |
| Prostate-specific antigen (ng/mL) | |||||
| Median (IQR) | 67 (23–200) | 59 (22–172) | 70 (27–181) | 63 (21–183) | |
| Range | 0–15747 | 0–13300 | 1–9999 | 1–8503 | |
| Days from diagnosis | |||||
| Median (IQR) | 75 (55–99) | 76 (56–101) | 76 (56–99) | 76 (56–100) | |
| Range | 0–4070 | 1–4174 | 3–5033 | 6–4485 | |
| Missing | 5 | 8 | 7 | 6 | |
| Pain from prostate cancer | |||||
| Absent | 984 (85%) | 496 (84%) | 490 (84%) | 483 (84%) | |
| Present | 179 (15%) | 93 (16%) | 96 (16%) | 94 (16%) | |
| Missing | 21 | 4 | 6 | 16 | |
| T category at randomisation | |||||
| T0 | 7 (1%) | 3 (1%) | 2 (0%) | 2 (0%) | |
| T1 | 21 (2%) | 7 (1%) | 0 (0%) | 5 (1%) | |
| T2 | 113 (10%) | 53 (9%) | 60 (10%) | 67 (11%) | |
| T3 | 756 (64%) | 395 (67%) | 390 (66%) | 371 (63%) | |
| T4 | 211 (18%) | 92 (16%) | 105 (18%) | 100 (17%) | |
| TX | 76 (6%) | 43 (7%) | 35 (6%) | 48 (8%) | |
| N category at randomisation | |||||
| N0 | 522 (44%) | 258 (44%) | 260 (44%) | 265 (45%) | |
| N+ | 594 (50%) | 303 (51%) | 298 (50%) | 293 (49%) | |
| NX | 68 (6%) | 32 (5%) | 34 (6%) | 35 (6%) | |
| Metastases | |||||
| None | 460 (39%) | 227 (38%) | 230 (39%) | 228 (38%) | |
| Any metastases | 724 (61%) | 366 (62%) | 362 (61%) | 365 (62%) | |
| Bone metastases | 634 (54%) | 302 (51%) | 307 (52%) | 310 (52%) | |
| Liver metastases | 15 (1%) | 12 (2%) | 6 (1%) | 9 (2%) | |
| Lung metastases | 33 (3%) | 17 (3%) | 13 (2%) | 14 (2%) | |
| Nodal metastases | 220 (19%) | 120 (20%) | 102 (17%) | 116 (20%) | |
| Other metastases | 46 (4%) | 33 (6%) | 25 (4%) | 21 (4%) | |
| Broad disease grouping | |||||
| Newly diagnosed N0M0 | 256 (22%) | 120 (20%) | 131 (22%) | 131 (22%) | |
| Newly diagnosed N+M0 | 171 (14%) | 88 (15%) | 86 (15%) | 76 (13%) | |
| Newly diagnosed M1 | 690 (58%) | 351 (59%) | 347 (59%) | 350 (59%) | |
| Previously treated M0 | 33 (3%) | 19 (3%) | 13 (2%) | 21 (4%) | |
| Previously treated M1 | 34 (3%) | 15 (3%) | 15 (3%) | 15 (3%) | |
| Gleason sum score | |||||
| ≤7 | 282 (24%) | 122 (21%) | 110 (19%) | 117 (20%) | |
| 8–10 | 810 (68%) | 421 (71%) | 436 (74%) | 425 (72%) | |
| Unknown | 92 (8%) | 50 (8%) | 46 (8%) | 51 (9%) | |
| Aspirin or NSAID use | |||||
| No | 891 (75%) | 448 (76%) | 444 (75%) | 445 (75%) | |
| Yes | 293 (25%) | 145 (24%) | 148 (25%) | 148 (25%) | |
| Planned or current hormone therapy* | |||||
| Orchidectomy | 5 (0%) | 4 (1%) | 2 (0%) | 3 (1%) | |
| LHRH-based | 1166 (98%) | 581 (98%) | 581 (98%) | 582 (98%) | |
| Bicalutamide | 11 (1%) | 7 (1%) | 9 (2%) | 8 (2%) | |
| Maximum androgen blockade | 2 (0%) | 1 (0%) | 0 (0%) | 0 (0%) | |
| Time to starting hormone therapy (days) | |||||
| Median (IQR) | −41 (−63 to −20) | −40 (−62 to −20) | −43 (−66 to −21) | −43 (−63 to −22) | |
| Range | −105 to 77 | −193 to 32 | −108 to 45 | −142 to 28 | |
| Missing | 1 | 0 | 2 | 0 | |
| Planned anti-androgen use | |||||
| No | 102 (9%) | 67 (12%) | 52 (9%) | 57 (10%) | |
| Short-term anti-androgen | 876 (76%) | 420 (72%) | 437 (75%) | 434 (75%) | |
| Long-term anti-androgen | 178 (15%) | 95 (16%) | 92 (16%) | 91 (16%) | |
| Missing | 28 | 11 | 11 | 11 | |
| Radiotherapy planned | |||||
| No | 844 (71%) | 421 (71%) | 424 (72%) | 423 (71%) | |
| Yes | 340 (29%) | 172 (29%) | 168 (28%) | 170 (29%) | |
| Does patient smoke? | |||||
| No | 1006 (87%) | 492 (84%) | 506 (86%) | 496 (84%) | |
| Yes | 157 (13%) | 93 (16%) | 81 (14%) | 92 (16%) | |
| Missing on assessment | 16 | 6 | 4 | 4 | |
| Assessment not received | 5 | 2 | 1 | 1 | |
| Does patient have diabetes | |||||
| No | 1058 (90%) | 544 (92%) | 535 (91%) | 516 (88%) | |
| Yes, type 1 | 29 (2%) | 11 (2%) | 26 (4%) | 16 (3%) | |
| Yes, type 2 | 89 (8%) | 36 (6%) | 30 (5%) | 57 (10%) | |
| Missing on assessment | 3 | 0 | 0 | 3 | |
| Assessment not received | 5 | 2 | 1 | 1 | |
| Myocardial infarction | |||||
| No | 1146 (97%) | 578 (98%) | 575 (98%) | 571 (97%) | |
| Yes, but still fit for trial | 31 (3%) | 13 (2%) | 14 (2%) | 18 (3%) | |
| Missing on assessment | 2 | 0 | 2 | 3 | |
| Assessment not received | 5 | 2 | 1 | 1 | |
| Cerebrovascular disease | |||||
| No | 1164 (99%) | 579 (98%) | 583 (99%) | 580 (98%) | |
| Yes, but still fit for trial | 13 (1%) | 12 (2%) | 6 (1%) | 9 (2%) | |
| Missing on assessment | 2 | 0 | 2 | 3 | |
| Assessment not received | 5 | 2 | 1 | 1 | |
| Congestive heart failure | |||||
| No | 1172 (100%) | 588 (99%) | 588 (100%) | 589 (100%) | |
| Yes, but still fit for trial | 5 (0%) | 3 (1%) | 2 (0%) | 0 (0%) | |
| Missing on assessment | 2 | 0 | 1 | 3 | |
| Assessment not received | 5 | 2 | 1 | 1 | |
| Angina | |||||
| No | 1138 (97%) | 567 (96%) | 574 (97%) | 569 (97%) | |
| Yes, but still fit for trial | 39 (3%) | 24 (4%) | 17 (3%) | 20 (3%) | |
| Missing on assessment | 2 | 0 | 0 | 3 | |
| Assessment not received | 5 | 2 | 1 | 1 | |
| Hypertension | |||||
| No | 741 (63%) | 384 (65%) | 383 (65%) | 385 (65%) | |
| Yes, but still fit for trial | 437 (37%) | 206 (35%) | 208 (35%) | 204 (35%) | |
| Missing on assessment | 1 | 1 | 0 | 3 | |
| Assessment not received | 5 | 2 | 1 | 1 | |
Data are median (IQR), range, or n (%). NSAID=non-steroidal anti-inflammatory drug. LHRH=luteinising hormone-releasing hormone.
*
Further information provided in the appendix.