Table 1.
Patient characteristics
| Parameters | Total (n=37) | Arm 1 (n=20) | Arm 2 (n=17) | p-value | |||
| No. | % | No. | % | No. | % | ||
| Age, years | 0.67 | ||||||
| Median | 75 | 75 | 74 | ||||
| Range | 53–86 | 53–86 | 55–84 | ||||
| Race: white | 4 | 10.80 | 2 | 10.00 | 2 | 11.80 | 0.94 |
| Disease location | 0.55 | ||||||
| Bone only | 19 | 51.40 | 9 | 45 | 10 | 58.80 | |
| Soft tissue only | 5 | 13.50 | 2 | 10 | 3 | 17.60 | |
| Bone and soft tissue | 11 | 29.70 | 7 | 35 | 4 | 23.50 | |
| Visceral | 2 | 5.40 | 2 | 10 | 0 | ||
| Number of bone mets | 0.51 | ||||||
| 0 | 7 | 18.90 | 3 | 15 | 4 | 23.50 | |
| 1-10 | 17 | 45.90 | 11 | 55 | 6 | 35.30 | |
| >10 | 13 | 35.10 | 6 | 30 | 7 | 41.20 | |
| ECOG performance status | 0.57 | ||||||
| 0 | 27 | 73 | 14 | 70 | 13 | 76.50 | |
| 1 | 9 | 24.3 | 6 | 30 | 3 | 17.60 | |
| 2 | 1 | 2.70 | 0 | 1 | 5.90 | ||
| Median PSA, ng/mL Range |
21.9 0.33–636.8 |
20.2 2.1–636.8 |
26.3 0.33–529 |
0.71 | |||
| Median alkaline phosphatase, U/L Range |
76 41–741 |
68.5 41–321 |
92 46–741 |
0.28 | |||
| Median hemoglobin, g/dL Range |
13 9.8–15.3 |
12.9 10.2–15.3 |
13 9.8–14.9 |
0.98 | |||
| Median LDH, U/L Range |
181 114–677 |
180 114–677 |
181 130–229 |
0.32 | |||
| Gleason Score | 1 | ||||||
| ≤7 | 17 | 45.90 | 9 | 45 | 8 | 47.10 | |
| ≥8 | 15 | 40.50 | 8 | 40 | 7 | 41.20 | |
| Unknown | 5 | 13.50 | 3 | 15 | 2 | 11.80 | |
| Patients with prior chemotherapy for mCRPC | 7 | 18.90 | 3 | 15 | 4 | 23.50 | 0.68 |
| Patients receiving docetaxel-based chemotherapy subsequent to study treatment | 11 | 29.70 | 6 | 30 | 5 | 29.40 | 1 |
| Patients with two or more previous anti-androgen therapies | 23 | 62.20 | 14 | 70 | 9 | 52.90 | 0.33 |