Table 1. Baseline characteristics of all patients in the comparison.
| Characteristic | SOC (n = 1,029) | SOC+RT (n = 1,032) | |
|---|---|---|---|
| Age at randomisation (years) | Median (IQR) | 68 (63 to 73) | 68 (63 to 73) |
| Range | 37 to 86 | 45 to 87 | |
| WHO performance status | 0 | 732 (71%) | 734 (71%) |
| 1 to 2 | 297 (29%) | 298 (29%) | |
| Pain from prostate cancer | Absent | 826 (81%) | 855 (83%) |
| Present | 198 (19%) | 172 (17%) | |
| Missing | 5 | 5 | |
| Previous notable health issues | Myocardial infarction | 67 (7%) | 58 (6%) |
| Cerebrovascular disease | 29 (3%) | 32 (3%) | |
| Congestive heart failure | 5 (<1%) | 8 (1%) | |
| Angina | 46 (4%) | 52 (5%) | |
| Hypertension | 408 (40%) | 444 (43%) | |
| T-category at randomisation | T0 | 0 (0%) | 1 (<1%) |
| T1 | 12 (1%) | 12 (1%) | |
| T2 | 84 (9%) | 89 (9%) | |
| T3 | 585 (62%) | 603 (63%) | |
| T4 | 260 (28%) | 247 (26%) | |
| TX | 88 | 80 | |
| N-category at randomisation | N0 | 345 (36%) | 344 (36%) |
| N+ | 620 (64%) | 620 (64%) | |
| NX | 64 | 68 | |
| Metastatic burden | Low metastatic burden* | 409 (42%) | 410 (43%) |
| High metastatic burden | 567 (58%) | 553 (57%) | |
| Not classified | 53 | 69 | |
| Sites of metastases | Bone | 919 (89%) | 917 (89%) |
| Liver | 23 (2%) | 19 (2%) | |
| Lung | 42 (4%) | 48 (5%) | |
| Distant lymph nodes | 295 (29%) | 304 (29%) | |
| Other | 35 (3%) | 32 (3%) | |
| Gleason sum score | < = 7 | 173 (17%) | 175 (18%) |
| 8 to 10 | 826 (83%) | 820 (82%) | |
| Unknown | 30 | 37 | |
| PSA pre-ADT (ng/ml) | Median (IQR) | 98 (30 to 316) | 97 (33 to 313) |
| Range | 1 to 20,590 | 1 to 11,156 | |
| Time from diagnosis (days) | Median (IQR) | 73 (55 to 94) | 73 (55 to 93) |
| Missing | 1 | 2 | |
| Days from starting hormones | Median (IQR) | 53 (35 to 70) | 55 (34 to 70) |
| Range | -3 to 84 | 0 to 86 | |
| Missing | 17 | 13 | |
| Planned for SOC docetaxel | No | 845 (82%) | 849 (82%) |
| Yes | 184 (18%) | 183 (18%) | |
| Nominated RT schedule | 36 Gy/6 f over 6 weeks | 482 (47%) | 498 (48%) |
| 55 Gy/20 f over 4 weeks | 547 (53%) | 534 (52%) |
*Note: One patient classified with low-burden disease was subsequently restaged as nonmetastatic by the randomising site. They remain in the low metastatic burden subgroup for this analysis.
ADT, androgen deprivation therapy; IQR, interquartile range; PSA, prostate specific antigen; RT, radiotherapy to the prostate; SOC, standard of care; WHO, World Health Organization.