Table 2. Combination drug trials.
| Combination drug | Trial name | Number of patients | Dose | Control arm | Prior local therapy (%) | High volume/risk (%) | Prior concurrent Docetaxel (%) | Median follow up (months) | OS | Discontinued due to adverse effect (%) | Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Docetaxel | GETUG-AFU 15 | 385 | 75 mg/m2 IV 3 weekly up to 9 cycles | ADT plus non-steroidal ARPI | NR | 48 | Excluded | 83.9 | Median OS 13.5 months longer in Docetaxel arm | 21 | |
| CHAARTED | 790 | 75 mg/m2 IV 3 weekly for 6 weeks | ADT | 28 | 65 | Excluded | 53.7 | Median OS 10.4 months longer in Docetaxel arm | 14 | ||
| STAMPEDE | 1,776 | 75 mg/m2 IV 3 weekly for 6 weeks | ADT | 6 | 60 | Excluded | 43 | Median OS 15 months longer in Docetaxel arm | 13 | OS for metastatic disease only | |
| Abiraterone | LATITUDE | 1,199 | 1,000 mg daily with 5mg daily prednisone | ADT plus placebo | 0 | 100 | Excluded | 51.8 | Median OS 16.8 months longer in Abiraterone arm | 16 | High risk patients only |
| STAMPEDE | 1,917 | 1,000 mg daily with 5mg daily prednisone | ADT | 5 | 55 | Excluded | 40 | Hazard ratio for death 0.61 (P<0.001) | NR | OS of metastatic disease only | |
| Enzalutamide | ENZAMET | 1,125 | 160 mg daily | ADT plus standard of care non-steroidal ARPI | 42 | 52 | 45 | 34 | Hazard ratio for death 0.67 (P=0.002) | 6 | |
| ARCHES | 1,150 | 160 mg daily | ADT plus placebo | 27 | 63 | 18 | 14.4 | OS statistics not yet mature. Risk of radiographic disease progression reduced by 61% in Enzalutamide arm | 7 | ||
| Apalutamide | TITAN | 1,052 | 240 mg daily | ADT plus placebo | 19 | 63 | 11 | 22.7 | Hazard ratio for death 0.67 (P=0.005) | 8 |
ADT, androgen deprivation therapy (surgical castration, LHRH agonist or LHRH antagonist); ARPI, androgen receptor pathway inhibitor; OS, overall survival; NR, not reached/reported.