Table 1.
Study characteristics
| Trial | PROSPER | SPARTAN | ARAMIS |
|---|---|---|---|
| Author | Hussain | Smith | Fizazi |
| Year | 2018 | 2018 | 2019 |
| Agents | Enzalutamide+ADT | Apalutamide+ADT | Darolutamide+ADT |
| Dosage | 160mg | 240mg | 600mg |
| Control | Placebo+ADT | Placebo+ADT | Placebo+ADT |
| Inclusion criteria |
M0N0CRPC, PSADT < 10 months, PSA >2 ng/ml |
M0N0-N1CRPC, PSADT <10 months |
M0N0-N1CRPC, PSADT < 10 months, PSA >2 ng/ml |
| Number | 1401 | 1207 | 1509 |
| Number (Treatment) | 933 | 806 | 955 |
| Number (Control) | 468 | 401 | 554 |
| Median Age (range) | 74 (50−95) vs. 73 (53−92) | 74 (48−94) vs. 74 (52−97) | 74 (48−95) vs. 74 (50−92) |
| Median PSA at baseline (ng/ml) | 11.1 vs. 10.2 | 7.78 vs. 7.96 | 9.0 vs. 9.7 |
| Median PSADT (months) | 3.8 vs. 3.6 | 4.4 vs. 4.5 | 4.4 vs. 4.7 |
| Proportion of N1 | 0% vs. 0% | 16.5% vs. 16.2% | 17% vs. 29% |
| Metastasis free survival | 36.6 vs. 14.7, HR 0.29 95% CI 0.24-0.35 | 40.5 vs. 16.2, HR 0.28 95% CI 0.23-0.35 | 40.4 vs. 18.4, HR 0.41 95% CI 0.34-0.5 |
| PSA progression free survival | 37.2 vs. 3.9, HR 0.07 95% CI 0.05-0.08 | NR vs. 3.7, HR 0.06 95% CI 0.05-0.08 | 33.2 vs. 7.3, HR 0.13 95% CI 0.11-0.16 |
| Overall survival | 67 vs. 56.3, HR 0.73 95% CI 0.61-0.89 | NR vs. NR, HR0.75 95% CI 0.59-0.96 | NR vs. NR, HR 0.71 95% CI 0.5-0.99 |
| Any grade AE rate | 87% vs. 77% | 96.5% vs. 93.2% | 83.2% vs. 76.9% |
| Grade 3 or 4 AE rate | 31% vs. 23% | 24.8% vs. 23.1% | 24.7% vs. 19.5% |
| Grade 5 AE rate | 3% vs. 1% | 1.2% vs. 0.3% | 3.9% vs. 3.2% |
| Discontinuation rate | 9% vs. 6% | 10.6% vs. 7.0% | 8.9% vs. 8.7% |
| Median follow up (months) | 48 | 41 | 17.9 |
ADT androgen deprivation therapy, CRPC castration-resistant prostate cancer, PSA prostate-specific antigen, PSADT PSA doubling time, NR not reached, HR hazard ratio, CI confidential interval, AE adverse event