Table 2.
Primary and Secondary End Points.*
| End Point | Enzalutamide Group (N = 933) | Placebo Group (N = 468) | Hazard Ratio (95% CI) | P Value |
|---|---|---|---|---|
| Primary end point | ||||
| Median metastasis-free survival — mo | 36.6 | 14.7 | 0.29 (0.24–0.35) | <0.001 |
| Metastasis or death — no. (%)† | 219 (23) | 228 (49) | — | — |
| Radiographic progression — no./total no. (%) | 187/219 (85) | 224/228 (98) | — | — |
| New bone metastases | 71/219 (32) | 79/228 (35) | — | — |
| New soft-tissue metastases | 109/219 (50) | 132/228 (58) | — | — |
| Metastases to lymph node | 79/219 (36) | 116/228 (51) | — | — |
| Visceral metastases | 34/219 (16) | 27/228 (12) | — | — |
| Concurrent new bone and soft-tissue metastases | 7/219 (3) | 13/228 (6) | — | — |
| Metastases to lymph node | 7/219 (3) | 12/228 (5) | — | — |
| Visceral metastases | 3/219 (1) | 1/228 (<1) | — | — |
| Death — no./total no (%)† | 32/219 (15) | 4/228 (2) | — | — |
| Secondary end points | ||||
| PSA progression | ||||
| Median time to progression — mo | 37.2 | 3.9 | 0.07 (0.05–0.08) | <0.001 |
| Patients with progression — no. (%) | 208 (22) | 324 (69) | — | — |
| Use of subsequent antineoplastic therapy | ||||
| Median time to first use — mo | 39.6 | 17.7 | 0.21 (0.17–0.26) | <0.001 |
| Patients with use — no. (%) | 142 (15) | 226 (48) | — | — |
| Overall survival | ||||
| Median survival — mo | NR | NR | 0.80 (0.58–1.09) | 0.15 |
| Patients who died — no. (%) | 103 (11) | 62 (13) | — | — |
| Confirmed PSA response ≥50% — no. (%) | 712 (76) | 11 (2) | — | — |
| FACT-P score degradation‡ | ||||
| Median time to score degradation — mo | 11.1 | 11.1 | 0.92 (0.79–1.08) | — |
| Patients with score degradation — no. (%) | 506 (54) | 239 (51) | — | — |
In the analysis of metastasis-free survival, the hazard ratio is for metastasis or death. In the analysis of overall survival, the hazard ratio is for death. NR denotes not reached.
Death was defined as death without evidence of radiographic progression that occurred in the period from randomization to 112 days after the discontinuation of the trial regimen. Causes of death are presented in Table S2 in the Supplementary Appendix.
Scores on the Functional Assessment of Cancer Therapy–Prostate (FACT-P) scale range from 0 to 156, with higher scores indicating more favorable health-related quality of life. Degradation in the FACT-P score was defined as a decrease of at least 10 points from baseline in the global score for each patient.