Table 2.
Phase III Clinical Trial of Novel Endocrine Therapy for mHSPC.
| No. | Trial name | Treatment | Results | Ref. |
|---|---|---|---|---|
| 1 | LATITUDE | ADT + abiraterone + prednisone (N = 597) vs ADT + placebo (N = 602) | Median OS: 53.3 months vs 36.5 months (HR 0.66; 95% CI 0.56-0.78; P < 0.001); Median PFS: 33.0 months vs 14.8 months (HR of progression or death 0.47; 95% CI 0.39-0.55; P < 0.001) |
(4, 5) |
| 2 | TITAN | ADT + apalutamide (N = 525) vs ADT + placebo (N = 527) | OS at 24 months: 82.4% vs 73.5% (HR 0.67; 95% CI 0.51-0.89; P = 0.005); PFS at 24 months: 68.2% vs 47.5% (HR 0.48; 95% CI 0.39-0.60; P < 0.001) |
(6) |
| 3 | ENZAMET | ADT + enzalutamide (N = 563) vs ADT + nonsteroidal antiandrogen agent (N = 562) | Median OS: NR vs 73.2 months (HR 0.70; 95% CI 0.58-0.84; P < 0.001); 5-year overall survival: 67% (0.63-0.70) vs 57% (0.53-0.61) |
(7) |
| 4 | ARCHES | ADT + enzalutamide (N = 574) vs ADT + placebo (N = 576) | OS: Not mature; rPFS: NR vs 19.0 months (HR 0.39; 95% CI 0.30-0.50; P < 0.001) |
(8) |
| 5 | ARASENS | ADT + darolutamide + docetaxel (N = 651) vs ADT + placebo +docetaxel (N = 655) | Median OS: NR vs 48.9 months (HR 0.68; 95% CI 0.57-0.80; P < 0.001); Median time to CRPC: NR vs 19.1 months (HR 0.36; 95% CI 0.30-0.42; P < 0.001) |
(9) |
| 6 | CHART | ADT + rezvilutamide (N = 326) vs ADT + bicalutamide (N = 328) | Median OS: NR vs NR (HR 0.58; 95% CI 0.44-0.77; P < 0.001); Median rPFS: NR vs 25.1 months (HR 0.44; 95% CI 0.33-0.58; P < 0.001) |
(10) |