Table 1:
Baseline Characteristics
| Overall (n=106) |
Phase I (n=18) |
Phase II (n=88) | |||
|---|---|---|---|---|---|
| Enz (n=33) |
Enz + Mif (n=33) |
NR (n=22) |
|||
| Age, years | |||||
| Median (range) | 69 (52-58) | 70 (55-84) | 71 (52-83) | 71 (57-85) | 68 (52-58) |
| >75, No. (%) | 34 (32) | 5 (28) | 10 (30) | 14 (42) | 5 (23) |
| ECOG PS, No (%) | |||||
| 0 or 1 | 46 (43) | 10 (56) | 13 (39) | 16 (49) | 7 (32) |
| 2 | 60 (57) | 8 (44) | 20 (61) | 17 (52) | 15 (68) |
| Race, No. (%) | |||||
| White | 76 (72) | 12 (67) | 20 (61) | 26 (79) | 16 (73) |
| AA | 25 (24) | 6 (33) | 9 (27) | 7 (21) | 3 (14) |
| Asian | 2 (2) | 0 | 2 (6) | 0 | 0 |
| Other | 3 (3) | 0 | 2 (6) | 0 | 1 (5) |
| Prior Docetaxel No. (%) | 36 (34) | 7 (39) | 9 (27) | 6 (19) | 14 (64) |
| Disease Location, No. (%) | |||||
| Bones | 73 (69) | 16 (89) | 22 (67) | 19 (58) | 16 (73) |
| Lymph Nodes | 57 (54) | 11 (61) | 17 (52) | 18 (55) | 11 (50) |
| Viscera | 30 (28) | 6 (33) | 9 (27) | 6 (18) | 9 (41) |
| PSA (ng/mL), median (range) | 11.0 (0.1-616) | 7.1 (1.5-616) | 14.4 (2.2-342) | 12.3 (0.2-77.7) | 10.4 (0.1-380) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; NR, not randomized; PS, performance status