Table 5.
Summary of clinical trials and the current study.
| Entry | SPARTAN (apalutamide) | PROSPER (enzalutamide) | ARAMIS (darolutamide) | JUOG study | |
|---|---|---|---|---|---|
| PSADT ≤ 10 months | PSADT ≤ 10 months | PSADT ≤ 10 months | PSADT ≤ 10 months | Whole cohort | |
| Median PSADT (months) | 4.4 | 4.5 | 4.5 | 4.3 | 5.3 |
| PSA (ng/mL) | 7.8 | 9.2 | 9.2 | 3.1 | 3.3 |
| F/U periods | 52 | 48 | 29 | 33 | 33 |
| PSA-PFS (months) ARAT/cont | NR/3.7 (HR 0.06) | 37.2/3.9 (HR 0.07) | NR/NR (HR 0.71) | 29.4/6.0 (HR 0.34) | 29.7/8.2 (HR 0.38) |
| OS (months) ARAT/cont | 73.9/59.9 (HR 0.78) | 67.0/56.3 (HR 0.73) | NR/NR (HR 0.69) | NR/76.7 months (HR 1.04) | NR/94.8 months (HR 1.11) |
NHT novel hormonal therapy, Cont control, F/U periods follow-up periods, HR hazard ratio, NR not reached, OS overall survival, PSA prostate specific antigen, PSADT PSA doubling time, PFS progression-free survival.