Table 1.
Baseline characteristics for all metastatic patients, by trial arm
| Patient characteristic | Control | Docetaxel | ||
|---|---|---|---|---|
| Randomised (2 : 1 allocation) | 724 | 100% | 362 | 100% |
| Age at randomisation (years) | ||||
| Median | 65 | 65 | ||
| IQR | 60–71 | 60–70 | ||
| WHO performance status | ||||
| 0 | 521 | 72% | 270 | 75% |
| 1–2 | 203 | 28% | 92 | 25% |
| T stage | ||||
| T0 | 3 | <1% | 1 | <1% |
| T1 | 12 | 2% | 0 | 0% |
| T2 | 75 | 10% | 51 | 14% |
| T3 | 404 | 56% | 197 | 54% |
| T4 | 163 | 23% | 82 | 23% |
| TX | 67 | 9% | 31 | 9% |
| Nodal status | ||||
| N0 | 242 | 33% | 118 | 33% |
| N+ | 416 | 57% | 211 | 58% |
| NX | 66 | 9% | 33 | 9% |
| Metastatic burdena | ||||
| Low | 238 | 33% | 124 | 34% |
| High | 320 | 44% | 148 | 41% |
| Unassessed | 166 | 23% | 90 | 25% |
| Site of metastasesb | ||||
| Bone | 634 | 88% | 307 | 85% |
| Liver | 15 | 2% | 6 | 2% |
| Lung | 33 | 5% | 13 | 4% |
| Nodesc | 221 | 31% | 102 | 28% |
| Other | 46 | 6% | 25 | 7% |
| Gleason sum score | ||||
| ≤7 | 158 | 22% | 65 | 18% |
| 8–10 | 480 | 66% | 253 | 70% |
| Unknown | 86 | 12% | 44 | 12% |
| PSA | ||||
| Median | 102.5 | 97 | ||
| IQR | 32.8–354 | 40.5–340 | ||
| Time from diagnosis to randomisation (days) | ||||
| Median | 69 | 73 | ||
| IQR | 49–92 | 55–95 | ||
| Planned SOC RTd | ||||
| Not planned | 677 | 94% | 333 | 92% |
| Planned | 47 | 6% | 29 | 8% |
| Previously treated | ||||
| No | 689 | 95% | 347 | 96% |
| Yes | 35 | 5% | 15 | 4% |
| Pain from prostate cancer | ||||
| Absent | 553 | 76% | 270 | 75% |
| Present | 154 | 21% | 88 | 24% |
| Unknown | 17 | 2% | 4 | 1% |
| Year of randomisation | ||||
| 2005 | 1 | <1% | 1 | <1% |
| 2006 | 28 | 4% | 14 | 4% |
| 2007 | 38 | 5% | 19 | 5% |
| 2008 | 70 | 10% | 34 | 9% |
| 2009 | 93 | 13% | 45 | 12% |
| 2010 | 111 | 15% | 58 | 16% |
| 2011 | 169 | 23% | 87 | 24% |
| 2012 | 172 | 24% | 85 | 23% |
| 2013 | 42 | 6% | 19 | 5% |
| Total | 724 | 100% | 362 | 100% |
a
CHAARTED definition.
b
Patients may have had more than one site of metastases at baseline, therefore are represented in more than one ‘site of metastases’ category. Percentages shown are per individual site for the total patients in the arm.
c
Non-regional lymph nodes.
d
Primary site RT was not standard-of-care (SOC) for M1 patients at the time of the trial. However, SOC RT was reported as planned for a small proportion of patients due to clinical decisions for these individual cases to receive RT to non-prostate locations, or due to mis-reporting of palliative RT.