Table 3.
Summary of efficacy outcomes
| Outcome | n (%) |
| All patients with response information | 25 (100) |
| PSA response* | 3 (12) |
| ORR | 0 (0) |
| DCR | 6 (24) |
| CR | 0 (0) |
| PR | 0 (0) |
| SD | 6 (24) |
| PSA PFS, months, median (CI) | 0.9 (0.9–1.8) |
| rPFS, months, median (CI) | 3.7 (1.9–5.7) |
| OS, months, median (CI) | 28.1 (14.5–37.3) |
| 12-month OS (SE) | 96% (4) |
| 24-month OS (SE) | 55% (10) |
| 36-month OS (SE) | 35% (10) |
Twenty-five patients included in the final efficacy analysis. One patient lost to follow-up after one combination dose excluded per protocol.
*Defined as PSA decline ≥50% from baseline. Includes 1 confirmed and 2 unconfirmed PSA50 responses.
CR, complete response; DCR, disease control rate at six months; NR, not reached; ORR, objective response rate (by RECIST V.1.1 with PCWG3 modifications); OS, overall survival; PFS, progression-free survival; PR, partial response; PSA, prostate-specific antigen; rPFS, radiographic progression-free survival; SD, stable disease.