Variable | All | Arm-1 | Arm-2 | p-value |
Response assessed per RECIST criteria | 23 | 10 | 13 | 0.38 |
No. of patients who can be assessed by RECIST | ||||
PR | 1 (4.3%) | 0 | 1 (7.7%) | |
SD | 4 (17.4%) | 3 (30%) | 1 (7.7%) | |
Non-CR/Non-PD | 5 (21.7%) | 1 (10%) | 4 (30.8%) | |
PD | 13 (56.5%) | 6 (60%) | 7 (53.8%) | |
ORR, No (%) | 1 (4.3%) | 0 | 1 (7.7%) | 1 |
DCR,* No (%) | 5 (21.7%) | 3 (30%) | 2 (15.4%) | 0.62 |
Response assessed per PCWG3 | 27 | 16 | 11 | 1 |
No. of patients who can be assessed by RECIST | ||||
PR | 0 | 0 | 0 | |
SD | 10 (37%) | 6 (37.5%) | 4 (36.4%) | |
PD | 17 (63%) | 10 (62.5%) | 7 (63.6%) | |
ORR, No (%) | 0 | 0 | 0 | 1 |
DCR, No (%) | 10 (37%) | 6 (37.5%) | 4 (36.4%) | 1 |
rPFS | 37 | 20 | 17 | 0.27 |
No. of patients who can be assessed median (95% CI) | 3.0 months (2.8 to 5.6) | 3.3 months (2.6 to 7.8) | 2.9 months (2.6 to 5.6) | |
PSA response † in patients with baseline PSA measurement No. of patients who can be assessed | 30 | 20 | 17 | |
PSA decline 50% † | 4 (10.8%) | 1 (5%) | 3 (17.6%) | 0.32 |
*Define as the percentage of patients with confirmed complete or partial response or stable disease. Patients who died without evidence of disease progression before death were considered to have stable disease.
†Define as the percentage of patients with a reduction in PSA level from baseline by 50% or greater as confirmed on an additional PSA evaluation performed > 3 weeks later.
CR, complete response; DCR, disease control rate; NE, not evaluable; ORR, overall response rate; PCWG3, Prostate Cancer Working Group 3; PD, progressive disease; PR, partial response; PSA, prostate specific antigen; rPFS, radiographic progression free survival.