Table 3

Summary of responses

VariableAllArm-1Arm-2p-value
Response assessed per RECIST criteria2310130.38
No. of patients who can be assessed by RECIST
PR1 (4.3%)01 (7.7%)
SD4 (17.4%)3 (30%)1 (7.7%)
Non-CR/Non-PD5 (21.7%)1 (10%)4 (30.8%)
PD13 (56.5%)6 (60%)7 (53.8%)
ORR, No (%)1 (4.3%)01 (7.7%)1
DCR,* No (%)5 (21.7%)3 (30%)2 (15.4%)0.62
Response assessed per PCWG32716111
No. of patients who can be assessed by RECIST
PR000
SD10 (37%)6 (37.5%)4 (36.4%)
PD17 (63%)10 (62.5%)7 (63.6%)
ORR, No (%)0001
DCR, No (%)10 (37%)6 (37.5%)4 (36.4%)1
rPFS3720170.27
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
302017
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.