Primary and Secondary Endpoints Results
| Outcome measure | Overall (n = 43) | 6.0 GBq (n = 14) | 7.4 GBq (n = 29) | Hazard ratio (95% CI) | P |
|---|---|---|---|---|---|
| Primary endpoint | |||||
| PSA response after 2 cycles | |||||
| No. of evaluable patients | 40 | 13 | 27 | ||
| PSA decline ≥ 50% after 2 cycles | 11 (28%, 95% CI 15–44) | 6 (46%, 95% CI 19–75) | 5 (19%, 95% CI 6–38) | — | 0.12* |
| Secondary endpoint | |||||
| Best PSA response | |||||
| No. of evaluable patients | 43 | 14 | 29 | ||
| Best PSA response ≥ 50% | 16 (37%, 95% CI 23–53) | 7 (50%, 95% CI 23–77) | 9 (31%, 95% CI 15–51) | — | 0.31* |
| Pain response | |||||
| No. of evaluable patients | 18 | 7 | 11 | ||
| Patients with pain improvement (n) | 12 (67%) | 6 (86%) | 6 (55%) | — | 0.31* |
| Pain PFS | |||||
| Median (mo) | 8.2 (95% CI 3.9–12.5) | 5.4 (not reached) | 8.2 (95% CI 2.3–14.1) | 0.96 (0.35–2.66) | 0.94 |
| Post hoc analysis | |||||
| OS | |||||
| Median (mo) | 14.0 (95% CI 10.1–17.9) | 15.8 (95% CI 11.8–19.4) | 13.5 (95% CI 10.0–17.0) | 0.94 (0.46–1.92) | 0.87 |
↵* P values compare the 6.0- and 7.4-GBq treatment arms using exact Fisher test.