Table 3

Summary of efficacy outcomes

Outcomen (%)
All patients with response information25 (100)
PSA response*3 (12)
ORR0 (0)
DCR6 (24)
 CR0 (0)
 PR0 (0)
 SD6 (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.