Table 1. Baseline Patient Characteristics by Exposure to Prior Prostate-Directed LT and Randomized Treatment Regimena.
| Characteristic | No prior LT (n = 384) | Prior LT (n = 795) | P value | ||
|---|---|---|---|---|---|
| ADT alone (n = 121)b | ADT plus apalutamide (n = 263) | ADT alone (n = 269)b | ADT plus apalutamide (n = 526) | ||
| Age at randomization, y | |||||
| Mean (SD) | 74 (8.6) | 74 (8.6) | 71 (7.6) | 71 (8.0) | <.001 |
| Median (range) | 75 (50-95) | 75 (50-95) | 70 (50-90) | 70 (45-90) | |
| PSADT, mo | |||||
| Mean (SD) | 5.0 (2.3) | 5.0 (2.3) | 4.6 (2.2) | 4.6 (2.3) | .03 |
| Median (range) | 4.5 (1.5-9.9) | 4.7 (1.1-9.7) | 4.4 (0.7-10.0) | 4.1 (0.8-10.0) | |
| Time since diagnosis, y | |||||
| Mean (SD) | 6.4 (4.3) | 5.8 (3.8) | 9.3 (5.1) | 9.9 (5.2) | <.001 |
| Median (range) | 5.0 (1.0-25.0) | 5.0 (0.5-19.0) | 9.0 (1.0-26.0) | 9.0 (1.0-30.0) | |
| Race and ethnicity | |||||
| Asian | 18 (14.9) | 50 (19.0) | 29 (10.8) | 41 (7.8) | <.001 |
| Black | 7 (5.8) | 8 (3.0) | 11 (4.1) | 38 (7.2) | |
| White | 78 (64.5) | 165 (62.7) | 191 (71.0) | 349 (66.4) | |
| Otherc | 18 (14.9) | 40 (15.2) | 38 (14.1) | 98 (18.6) | |
| Nodal stage | |||||
| N0 | 103 (85.0) | 213 (81.0) | 223 (82.9) | 444 (84.4) | .60 |
| N1 | 18 (15.0) | 50 (19.0) | 46 (17.1) | 82 (15.6) | |
| Prior bone-sparing agent | |||||
| No | 111 (91.7) | 240 (91.3) | 240 (89.2) | 470 (89.4) | .70 |
| Yes | 10 (8.3) | 23 (8.7) | 29 (10.8) | 56 (10.6) | |
| Primary Gleason score | |||||
| 1-3 | 37 (30.6) | 81 (30.8) | 104 (38.7) | 244 (46.4) | .001 |
| 4-5 | 77 (63.6) | 169 (64.3) | 155 (57.6) | 263 (50.0) | |
| Unassigned | 7 (5.8) | 13 (4.9) | 10 (3.7) | 19 (3.6) | |
| Secondary Gleason score | |||||
| 1-3 | 40 (33.1) | 70 (26.6) | 103 (38.3) | 194 (36.9) | .08 |
| 4-5 | 74 (61.2) | 179 (68.1) | 156 (58.0) | 310 (59.0) | |
| Unassigned | 7 (5.8) | 14 (5.3) | 10 (3.7) | 22 (4.1) | |
| Tumor stage group | |||||
| T1-T2 | 57 (47.1) | 111 (42.2) | 128 (47.6) | 294 (55.9) | <.001 |
| T3-T4 | 51 (42.1) | 120 (45.6) | 126 (46.8) | 207 (39.4) | |
| TX | 13 (10.7) | 32 (12.2) | 15 (5.6) | 25 (4.8) | |
| Prior ADT | |||||
| No | 43 (35.5) | 78 (29.7) | 78 (29.0) | 132 (25.1) | .11 |
| Yes | 78 (64.5) | 185 (70.3) | 191 (71.0) | 392 (74.9) | |
Abbreviations: ADT, androgen deprivation therapy; LT, local therapy; PSADT, prostate-specific antigen doubling time.
a
Unless indicated otherwise, values are presented as No. (%) of patients.
b
Placebo plus ADT.
c
Includes American Indian or Alaska Native (n = 4), unreported (n = 188), or other race or ethnicity (n = 2).