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 |