Table 3.
Characteristics of patients at randomisation
| HORRAD [11] |
STAMPEDE [12]a |
|||
|---|---|---|---|---|
| ADT | RT + ADT | ADT | RT + ADT | |
| Number of patients | 216 | 216 | 845 | 849 |
| Disease history | ||||
| Newly diagnosed M1 | 216 (100) | 216 (100) | 845 (100) | 849 (100) |
| Type of ADT, n (%) | ||||
| Orchiectomy | 4 (2) | 1 (<1) | 0 | 0 |
| LHRH agonist | 212 (98) | 210 (97) | 672 (80) | 684 (81) |
| LHRH antagonist | 0 | 0 | 165 (19) | 159 (18) |
| Missing | 0 | 5 (2) | 8 (1) | 6 (<1) |
| Time from initial diagnosis (mo), n (%) | ||||
| Median (IQR) | <1 (2–5 wk) | <1 (2–6 wk) | 2.4 (1.8–3.1) | 2.4 (1.8, 3.1) |
| Range | 0–42 | 0–25 | 0–114.8 | 0–41.9 |
| Missing | 0 | 0 | 5 | 14 |
| Time to ADT start (wk) | ||||
| Median (IQR) | −1 (−3, 0) | −1 (−3, 0) | −1.7 (−2.3, −1.1) | −1.7 (−2.3, −1.1) |
| Range | −17 to 2 | −13 to 2 | −2.8 to 1.1 | −2.8 to 0.3 |
| Missing | 2 | 4 | 0 | 1 |
| Age (yr) | ||||
| Median (IQR) | 67 (61–71) | 67 (62–71) | 68 (63, 73) | 68 (63, 73) |
| Range | 47–85 | 47–79 | 37–84 | 45–87 |
| WHO/ECOG performance status | ||||
| 0 | 176 (82) | 187 (87) | 597 (71) | 603 (71) |
| 1+ | 40 (18) | 29 (13) | 248 (29) | 246 (29) |
| PSA (ng/ml), n (%) | ||||
| Median (IQR) | 149 (50–483) | 125 (48–433) | 100 (30, 311) | 96 (33,299) |
| Range | 4–6991 | 8–14,000 | 1–20,590 | 1–11,156 |
| T category | ||||
| T0 | 0 | 0 | 0 | 2 (<1) |
| T1 | 5 (2) | 7 (3) | 11 (1) | 11 (1) |
| T2 | 20 (10) | 33 (15) | 69 (8) | 73 (9) |
| T3 | 128 (59) | 125 (58) | 474 (56) | 500 (59) |
| T4 | 59 (27) | 51 (24) | 222 (26) | 198 (23) |
| Tx | 4 (2) | 0 | 69 (9) | 65 (7) |
| N category, n (%) | ||||
| N0 | – | – | 293 (35) | 292 (34) |
| N+ | – | – | 500 (59) | 498 (59) |
| Nx | 216 (100) | 216 (100) | 52 (6) | 59 (7) |
| Gleason sum score, n (%) | ||||
| <8 | 71 (33) | 73 (34) | 151 (18) | 144 (17) |
| ≥8 | 144 (66) | 142 (65) | 668 (79) | 665 (78) |
| Unknown | 1 (<1) | 1 (<1) | 26 (3) | 40 (5) |
| Number of bone metastases, n (%) | ||||
| <5 | 71 (33) | 89 (41) | 404 (48) | 399 (47) |
| >5 | 145 (67) | 127 (58) | 397 (47) | 393 (46) |
| Unknown | – | – | 44 (5) | 57 (7) |
| Metastatic burden (HORRAD definitionb), n (%) | ||||
| Low burden | 35 (16) | 39 (18) | 385 (46) | 387 (46) |
| High burden | 181 (84) | 177 (82) | 416 (49) | 405 (48) |
| Unknown | – | – | 44 (5) | 57 (6) |
| Planned RT dose, n (%) | ||||
| 36 Gy in 6 fr over 6 wk, n (%) | NA | NA | NA | 416 (49) |
| 55 Gy in 20 fr over 4 wk n (%) | NA | NA | NA | 433 (51) |
| 70 Gy in 35 fr over 7 wk, n (%) | NA | 176 (82) | NA | NA |
| 57.76 Gy in 19 fr over 4 wk, n (%) | NA | 26 (12) | NA | NA |
| Unknown, n (%) | 14 (6) | |||
ADT = androgen deprivation therapy; fr = fraction; IQR = interquartile range; LHRH = luteinising hormone-releasing hormone; NA = not available; RT = radiotherapy.
a
Based on the participants who did not receive docetaxel as part of standard of care.
b
Low = Gleason sum score <9 and <5 bone lesions and PSA <142 (HORRAD median).