Table 1. Characteristics and results of the phase 3 randomized trials upon m1CSPC.
| TITAN (apalutamide) (20) | ARCHES (enzalutamide) (report from ASCO GU 2019) | ENZAMET (enzalutamide) (23) | LATITUDE (abiraterone) (22) |
|---|---|---|---|
| Apalutamide (240 mg/day) + ADT vs. placebo + ADT | Enzalutamide (160 mg/day) + ADT vs. placebo + ADT | Enzalutamide (160 mg/day) + ADT vs. (bicalutamide/flutamide/nilutamide) + ADT | AA (1,000 mg/day) + prednisone (5 mg) + ADT vs. dual placebo + ADT |
| Apalutamide: 525 patients | Enzalutamide: 574 patients | Enzalutamide: 563 patients | Abiraterone + prednisone: 597 patients |
| Placebo: 527 patients | Placebo: 576 patients | Bicalutamide/flutamide/nilutamide: 562 patients | Placebo: 602 patients |
| Median age: 68 years old | Median age: 70 years old | Median age: 68 years old | – |
| ECOG 0–1 | ECOG 0–1 | ECOG 0–2 | ECOG 0–2 |
| 67% Gleason score >7 | 66% Gleason score >8 at baseline | 58% Gleason score >8 at baseline | – |
| Previous treatment | Previous treatment | Previous treatment | Excluded if |
| 16.4%: prostatectomy or radiotherapy | 17.8%: docetaxel | 42%: prostatectomy | previous chemotherapy |
| 10.7%: docetaxel | 91%: ADT | 45%: docetaxel | radiation therapy |
| 37.7% antiandrogen | surgery for metastatic prostate cancer | ||
| 62.7% high disease volume | 63% high disease volume | 52% high disease volume | – |
| 37.3% low disease volume | 37% low disease volume | 47% low disease volume | |
| Median follow-up: 22.7 months | Median follow-up: 14.4 months | Median follow-up: 34 months | Median follow-up: 30.4 months |
| Results: RPFS at 24 months | Results: RPFS at 12 months | Results: clinical progression-free survival at 3 years | Results: RPFS |
| 68.2% vs. 47.5% | 84% vs. 64% | 68% vs. 41% | 33 vs. 14.8 months |
| HR 0.48; 0.39–0.60; P<0.001 | HR 0.39; 0.30–0.50; P<0.0001 | HR 0.40; 0.33 to 0.49; P<0.001 | HR 0.47; 0.39–0.55; P<0.001 |
| 52% lower risk of radiographic progression or death | 53% lower risk of radiographic progression or death | ||
| OS at 24 months | OS: IMMATURE | OS at 3 years | OS at 3 years |
| 82.4% vs. 73.5% | 80% vs. 72% | 66% vs. 49% | |
| HR 0.67, P=0.005 | HR 0.67; 0.52–0.86; P=0.002 | HR 0.62; 0.51–0.76; P<0.001 | |
| Grade 3 or 4 adverse events | Grade 3 or 4 adverse events | ||
| 42.2% vs. 40.8% | 63% vs. 48% |
ADT, androgen deprivation therapy; RFPS, radiographic progression-free survival; OS: overall survival; HR, hazard ratio; AA, abiraterone acetate.