Table 1 Demographics and baseline characteristics across pivotal clinical trials.
ARCHES | PROSPER | PREVAIL | AFFIRM | |||||
|---|---|---|---|---|---|---|---|---|
ENZA | PBO | ENZA | PBO | ENZA | PBO | ENZA | PBO | |
N | 574 | 576 | 933 | 468 | 872 | 845 | 800 | 399 |
Median age, years (range) | 70 (46–92) | 70 (42–92) | 74 (50–95) | 73 (53–92) | 72 (43–93) | 71 (42–93) | 69 (41–92) | 69 (49–89) |
ECOG, % | ||||||||
0 | 78.0 | 76.9 | 80 | 82 | 67.0 | 69.2 | 37 | 39 |
1 | 21.8 | 23.1 | 20 | 18 | 33 | 30.8 | 54 | 53 |
≥2 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 8 |
Time since diagnosis | ||||||||
Mean, months (SD) | 17.6 (37.5) | 19.99 (41.40) | 99.1 (57.3) | 94.1 (56.7) | 78.6 (59.1) | 76.2 (55.7) | 86.1 (54.8) | 81.9 (50.9) |
Median, months (range) | 3.5 (0.3–267.9) | 3.4 (0.4–259.1) | 90.4 (2.2–381.8) | 86.8 (2.2–275.7) | 62.7 (0.2–326.6) | 64.6 (0.1–275.4) | 70.9 (5.3–284.6) | 71.6 (10.6–268.0) |
Gleason score at diagnosis | ||||||||
≤7, % | – | – | 54.9 | 51.7 | 49.4 | 47.6 | 50 | 48 |
<8, % | 29.8 | 32.5 | – | – | ||||
≥8, % | 67.2 | 64.8 | 40.8 | 44.2 | 50.6 | 52.4 | 50 | 52 |
Unknown, % | – | – | 4.3 | 4.1 | – | – | ||
Missing, n | – | – | – | – | – | – | 74 | 31 |
Previous prostatectomy, % | 12.5 | 15.5 | 25.08 | 29.70 | 25.9 | 26.6 | 34.6 | 30.6 |
Previous primary radiation therapy, % | 16.4a | 16.7a | 32.58 | 33.76 | 39.0 | 39.1 | 37.5 | 41.9 |
Previous use of ADT, n (%) | ||||||||
None | 39 (6.8) | 61 (10.6) | 34 (3.6) | 24 (5.1) | 7 (0.8) | 7 (0.8) | 0 | 0 |
1 | – | – | 320 (34.3) | 142 (30.3) | 89 (10.2) | 94 (11.1) | 65 (8.2) | 35 (8.8) |
2 | – | – | 339 (36.3) | 151 (32.3) | 373 (42.8) | 360 (42.6) | 336 (42.3) | 151 (37.9) |
3 | – | – | 164 (17.6) | 101 (21.6) | 239 (27.4) | 237 (28.0) | 246 (31.0) | 120 (30.2) |
≥4 | – | – | 76 (8.1) | 50 (10.7) | 164 (18.8) | 147 (17.4) | 147 (18.5) | 92 (23.1) |
≤3 months | 414 (72.1) | 394 (68.4) | – | – | – | – | – | – |
>3 months | 121 (21.1) | 120 (20.8) | – | – | – | – | – | – |
Number of prior DOC regimens, % | ||||||||
1 | 18 | 18 | – | – | – | – | 72 | 74 |
≥2 | – | – | – | – | – | – | 28 | 26 |
Geographic scope, % | ||||||||
Europe | 59 | 60 | 49 | 50 | 53 | 53 | 58 | 56 |
North America | 15 | 13 | 15 | 13 | 25 | 25 | 33 | 33 |
RoW | 26 | 27 | 36 | 37 | 22 | 23 | 9 | 11 |
Disease localization at screening, % | ||||||||
Bone only | 47 | 43 | 1 | 1 | 40 | 40 | 28 | 31 |
Soft tissue only | 9 | 8 | 0 | <1 | 14 | 18 | 8 | 9 |
Bone and soft tissue | 38 | 42 | <1 | 0 | 45 | 42 | 63 | 60 |
None | – | – | 99 | 98 | 1 | 3 | – | – |
FACT-P, total | ||||||||
Mean (SD) | 113.9 (19.8) | 112.7 (19.0) | 119.5 (17.8) | 120.8 (16.7) | 119.6 (17.8) | 119.4 (17.9) | 108.7 (21.2) | 110.6 (20.8) |
