Table 1.
Patient Demographics for the 994 Eligible, Consenting Patients
| Docetaxel + Placebo (n=496) |
Docetaxel + Atrasentan (n=498) |
|
|---|---|---|
| Age in years, median (min, max) | 69 (43, 89) | 69 (40, 92) |
| Serum PSA in ng/ml, median (25%, 75%) | 67.7 (24.6, 202.4) | 79 (23.5, 228.3) |
| Hispanic n (%) | 20 (4%) | 21 (4%) |
| Race White n (%) Black n (%) Asian n (%) Unknown n (%) |
403 (81%) 64 (13%) 12 (2%) 14 (3%) |
403 (81%) 73 (15%) 8 (2%) 10 (2%) |
| Type of Progression at Study Entry Measureable/Evaluable (vs. PSA Only) n (%) |
394 (79%) | 407 (81%) |
| Bisphosphonate Usage at Study Entry n (%) | 305 (61%) | 304 (61%) |
| Worst Pain: BPI ≥4 (vs. < 4) 15 n (%) | 213 (43%) | 210 (42%) |
| Disease Extent Skeletal Mets Only n (%) Lymph Nodes n (%) Lung, Liver or Brain Mets n (%) Extra-skeletal but not enough information** n (%) |
206 (42%) 148 (30%) 94 (19%) 48 (10%) |
203 (41%) 149 (30%) 101 (20%) 45 (9 %) |
| Prior Prostatectomy n (%) | 145 (29%) | 168 (34%) |
| Performance Status 2–3 (vs. 0–1) n (%) | 39 (8%) | 36 (7%) |
| Gleason Score 5–6 n (%) 7 n (%) 8–10 n (%) Missing n (%) |
49 (10%) 137 (28%) 272 (55%) 38 (8%) |
52 (10%) 141 (28%) 275 (55%) 30 (6%) |
Unless noted, All 994 patients had a valid value for the factor.
**
Patient was stratified as having extra-skeletal disease, but not enough information was available to classify into a sub-category