Table 1.
Overview of the randomized double-blinded controlled trials examining enzalutamide and the patient-related outcome measures used
| Trial | Arms | Study design | n | Primary outcome | PRO instruments used |
|---|---|---|---|---|---|
| AFFIRM15 | Enzalutamide vs placebo (mCRPC post-chemo) | Phase III | 1,199 | OS; mOS 18.4 months vs 13.6 months (HR: 0.63, p<0.001) | FACT-P, BPI-SF |
| PREVAIL16 | Enzalutamide vs placebo (mCRPC pre-chemo) | Phase III | 1,717 | OS, radiographic PFS; deaths 28% vs 35% (HR: 0.71, p<0.001) | FACT-P, EQ-5D, BPI-SF |
| STRIVE17 | Enzalutamide vs bicalutamide (CRPC) | Phase II | 396 | PFS; in mCRPC 16.5 vs 5.5 months (HR: 0.24, p<0.001) | FACT-P |
| TERRAIN18 | Enzalutamide vs bicalutamide (mCRPC) | Phase III | 375 | PFS; 15.7 vs 5.8 months (HR: 0.44, p<0.0001) | FACT-P, BPI-SF |
Abbreviations: PRO, patient-related outcome; CRPC, castration-resistant prostate cancer; mCRPC, metastatic castration-resistant prostate cancer; FACT-P, Functional Assessment of Cancer Therapy-Prostate; OS, overall survival; HR, hazard ratio; PFS, progression-free survival; BPI-SF, Brief Pain Inventory – Short Form; mOS, median overall survival.