Table 3.
Efficacy analysis (ITT population). The data are presented as n (%) unless otherwise noted.
| Arm A (N = 34) | Arm B (N = 34) | |
|---|---|---|
| rPFS at 12 months | ||
| Rate | 0.84 | 0.89 |
| 95% CI | 0.6256–0.9366 | 0.6408–0.9726 |
| p value (log-rank) | 0.5712 | |
| PSA response | ||
| Rate | 0.647 | 0.735 |
| PSA-progression at 12 months | ||
| Rate | 0.49 | 0.49 |
| 95% CI | 0.2534–0.6622 | 0.2938–0.6589 |
| p value (log-rank) | 0.3803 | |
| Objective responsa | ||
| Complete response | 4 (20%) | 3 (20%) |
| Partial response | 4 (20%) | 3 (20%) |
| Stable disease | 8 (40%) | 7 (46.7%) |
| Progressive disease | 2 (10%) | 0 (0%) |
| Not evaluable | 2 (10%) | 2 (13.3%) |
aBased on the number of randomized patients with measurable disease at baseline (Arm A: 20 patients and Arm B: 15 patients).