TABLE 1.
Patient Demographic and Clinical Characteristics at Baseline (full analysis set)
| Characteristic | Darolutamide + ADT (n = 446) | Placebo + ADT (n = 223) |
|---|---|---|
| Median age (range), year | 70 (43-93) | 70 (45-91) |
| Age group, year, No. (%) | ||
| <65 | 118 (26.5) | 65 (29.1) |
| 65-74 | 193 (43.3) | 96 (43.0) |
| 75-84 | 117 (26.2) | 52 (23.3) |
| ≥85 | 18 (4.0) | 10 (4.5) |
| ECOG performance status, No. (%) | ||
| 0 | 235 (52.7) | 98 (43.9) |
| 1 | 199 (44.6) | 117 (52.5) |
| 2 | 12 (2.7) | 8 (3.6) |
| Race, No. (%) | ||
| White | 251 (56.3) | 125 (56.1) |
| Asian | 144 (32.3) | 65 (29.1) |
| Black | 41 (9.2) | 24 (10.8) |
| Other | 10 (2.2) | 9 (4.0) |
| Region, No. (%) | ||
| Asia | 141 (31.6) | 63 (28.3) |
| Latin American | 119 (26.7) | 72 (32.3) |
| Europe and rest of the world | 186 (41.7) | 88 (39.5) |
| Gleason score at initial diagnosis, No. (%) | ||
| <8 | 122 (27.4) | 67 (30.0) |
| ≥8 | 311 (69.7) | 146 (65.5) |
| Data missing | 13 (2.9) | 10 (4.5) |
| Metastasis stage at initial diagnosis,a No. (%) | ||
| De novo | 317 (71.1) | 168 (75.3) |
| Recurrent | 100 (22.4) | 45 (20.2) |
| Unknown | 29 (6.5) | 10 (4.5) |
| Extent of metastatic disease stage at screening, No. (%) | ||
| Nonregional lymph node metastases only | 17 (3.8) | 10 (4.5) |
| Bone metastases with or without lymph node metastases | 344 (77.1) | 171 (76.7) |
| Visceral metastases with or without lymph node metastases or with or without bone metastases | 85 (19.1) | 42 (18.8) |
| Disease volume,b No. (%) | ||
| High volume | 315 (70.6) | 157 (70.4) |
| Low volume | 131 (29.4) | 66 (29.6) |
| Median PSA level (range), ng/mLc | 21.4 (0.02-15,915) | 21.2 (0.02-8,533) |
| Median alkaline phosphatase level (range), U/L | 132.7 (34-4,286) | 147.0 (36-3,764) |
| Random assignment stratification factors | ||
| Visceral metastasesc | ||
| Present | 53 (11.9) | 27 (12.1) |
| Absent | 393 (88.1) | 196 (87.9) |
| Prior local therapy | ||
| Yes | 80 (17.9) | 40 (17.9) |
| No | 366 (82.1) | 183 (82.1) |
Abbreviations: ADT, androgen-deprivation therapy; ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen.
a
Recurrent disease is defined as stage I to IVA, and de novo is defined as stage IVB at initial diagnosis.
b
Disease volume defined by CHAARTED criteria: presence of visceral metastases and/or at least four bone metastases with at least one beyond vertebral bodies and pelvis.6
c
Centrally assessed.