Table 1 Baseline Characteristics (Safety Set)
Categories | SPARTAN | TITAN | PCR1008 | Total |
|---|---|---|---|---|
Number of patients in safety analysis set, n | 34 | 28 | 6 | 68 |
Median age, years (range) | 79.00 (61–90) | 73.00 (47–89) | 78.00 (70–85) | 77.00 (47–90) |
Median weight, kg (range) | 61.90 (45.5–84.0) | 63.55 (40.6–89.2) | 57.30 (49.8–62.6) | 61.80 (40.6–89.2) |
Median height, cm (range)a | 163.50 (140.0–176.4) | 165.20 (151.7–172.8) | 163.55 (147.0–165.9) | 164.00 (140.0–176.4) |
ECOG PSa, n (%) | ||||
0 | 30 (88.24) | 25 (89.29) | 5 (83.33) | 60 (88.24) |
1 | 4 (11.76) | 3 (10.71) | 1 (16.67) | 8 (11.76) |
Median time from initial diagnosis to first dose, month (range) | 87.10 (11.01–176.10) | 2.19 (1.28–74.15) | 68.89 (9.23–132.72) | 46.42 (1.28–176.10) |
GS at initial diagnosis, n (%) | ||||
≤ 7 | 9 (26.47) | 1 (3.57) | 2 (33.33) | 12 (17.65) |
≥ 8 | 25 (73.53) | 27 (96.43) | 4 (66.67) | 56 (82.35) |
Median PSA at baseline, ng/mL (range) | 4.35 (0.45–21.71) | 11.51 (0.04–457.64) | 54.42 (8.92–310.11) | 5.73 (0.04–457.64) |
Median Hemoglobin at baseline, ng/mL (range) | 12.95 (9.4–15.5) | 13.45 (10.2–15.9) | 11.95 (9.9–15.0) | 13.10 (9.4–15.9) |
Median LDH at baseline, U/L (range) | – | 198.00 (123–272) | 192.00 (115–456) | 197.50 (115–456) |
Median ALP at baseline, U/L (range) | 73.50 (33–137) | 104.50 (56–1149) | 204.50 (102–331) | 87.00 (33–1149) |
Disease status, n | ||||
nmCRPC | 55 | – | – | 55 |
mCSPC | – | 51 | – | 51 |
mCRPC | – | – | 6 | 6 |
Tumor volumeb, n (%) | ||||
High | – | 18 (64.29) | – | 18 (64.29) |
Low | – | 10 (35.71) | – | 10 (35.71) |
Previous treatment, n (%) | ||||
Local treatment | 21 (61.76) | 1 (3.57) | 2 (33.33) | 24 (35.29) |
RP | 5 (14.71) | 1 (3.57) | 1 (16.67) | 7 (10.29) |
RT | 19 (55.88) | 1 (3.57) | 1 (16.67) | 21 (30.88) |
Hormonal treatment | 34 (100.00) | 28 (100.00) | 6 (100.00) | 68 (100.00) |
LHRHa | 34 (100.00) | 28 (100.00) | 5 (83.33) | 67 (98.53) |
Orchiectomy | 1 (2.94) | 2 (7.14) | 1 (16.67) | 4 (5.88) |
1st generation AA | 33 (97.06) | 15 (53.57) | 6 (100.00) | 54 (79.41) |
Other | 2 (5.88) | 0 (0.00) | 0 (0.00) | 2 (2.94) |
Chemotherapy | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
Other | 3 (8.82) | 0 (0.00) | 2 (33.33) | 5 (7.35) |
Average dose of Apalutamide | ||||
Mean dose, mg (SD) | 223.94 (28.91) | 214.07 (44.90) | 225.84 (25.76) | 220.04 (36.05) |
Median dose, mg (range) | 236.55 (108.6–240.0) | 239.02 (90.6–240.0) | 236.10 (174.2–240.0) | 238.27 (90.6–240.0) |