Table 2 PSA kinetic parameters, mean ± SD (95 % CI)
JPN-201 (n = 48) | JPN-202 (n = 46) | |
|---|---|---|
Chemotherapy-naive | Chemotherapy-treated | |
Maximum % PSA decline | 64.4 ± 38.3 (53.3–75.5) | 19.7 ± 59.4 (2.0–37.3) |
Time to PSA nadir (months) | 5.3 ± 5.6 (3.7–6.9) | 2.0 ± 3.4 (1.0–3.0) |
Nadir PSA value (ng/mL) | 19.5 ± 28.3 (11.3–27.7) | 184.9 ± 282.3 (101.0–268.7) |
PSA response (≥30 %) at week 12, n (%; 95 % CI) | 35 (72.9; 58.2–84.7) | 15 (32.6; 19.5–48.0) |
PSA response (≥50 %) at week 12, n (%; 95 % CI) | 29 (60.4; 45.3–74.2) | 13 (28.3; 16.0–43.5) |
PSA response (≥90 %) at week 12, n (%; 95 % CI) | 9 (18.8; 8.9–32.6) | 2 (4.3; 0.5–14.8) |
PSA response (≥50 %) in treatment period, n (%; 95 % CI) | 30 (62.5; 47.48–76.0) | 13 (28.3; 16.0–43.5) |
Time to PSA progression (months) | 9.5 ± 7.4 (7.4–11.6) | 3.8 ± 4.8 (2.4–5.2) |