Table 5.
Major therapeutic benefits brought by enzalutamide based on PROSPER.
| Enzalutamide PROSPER Phase III Trial (NCT02003924) | |||
|---|---|---|---|
| End Points | Enzalutamide (n = 933) |
Placebo (n = 468) |
Hazard Ratio (95% CI) |
| Primary end point | |||
| Median MFS (mo) | 36.6 | 14.7 | 0.29 |
| Median time to rPFS (mo) | 3.9 | 0.19 | |
| Secondary end points | |||
| Median OS (mo) | |||
| Median time to C-FS (mo) | 38.1 | 34 | |
| Median first time use of CC (mo) | 39.7 | 0.38 | |
| Median time to PP (mo) | 18.5 | 18.4 | 0.96 |
| Median time to PSA progression (mo) | 37.2 | 3.9 | 0.07 |
| * PSA response (%) | |||
| decline ≥ 90% from baseline | 55.9 | 0.4 | |
| decline ≥ 50% from baseline | 76.3 | 2.4 | |
| decline to undetectable level | 9.6 | 0 | |
| * Serious AEs (%) of no. | 24.3 (930) | 18.9 (465) | |
MFS: Metastasis Free Survival; rPFS: Radiographic Progression-free Survival; OS: Overall Survival; C-FS: Chemotherapy-Free Survival; PP: Pain Progression; CC: Cytotoxic Chemotherapy; PSA: Prostate-specific Antigen; AEs: Adverse Events; * Does not include patients who discontinued or died during the trial.