Table 1 Demographics and baseline disease characteristics
Characteristic | Non-rising PSA group (n=65) | Rising PSA group (n=200) |
|---|---|---|
Age, median (IQR), years | 73 (68–79) | 71 (65–75) |
Weight, median (IQR), kg | 79.1 (73.9–89.5) | 84.1 (73.7–94.6) |
ECOG PS, n (%) | ||
0 | 46 (70.8) | 143 (71.5) |
1 | 19 (29.2) | 57 (28.5) |
Baseline pain score of 0–1 on BPI-SF Q3, n (%) | ||
0–1 | 47 (72.3) | 133 (68.2)a |
⩾2 | 18 (27.7) | 62 (31.8)a |
Hemoglobin, median (IQR), g l−1 | 131 (124–137) | 129 (123–137) |
Alkaline phosphatase, median (IQR), U l−1 | 80 (66–114) | 92 (70–141) |
Lactate dehydrogenase, median (IQR), U l−1 | 183 (167–203) | 183 (162–215) |
Albumin, median (IQR), g l−1 | 39 (36–40) | 38 (36–40) |
PSA, median (IQR), ng ml−1 | 82.2 (26.4–189.1) | 61.3 (22.4–111.5) |
Creatinine, median (IQR), μmol l−1 | 88.4 (79–99) | 85.5 (74–103) |
Time from initial diagnosis to randomization, median (IQR), months | 82.6 (48.1–132.2) | 59.6 (33.2–112.0) |
Gleason score, median (IQR) | 7 (7–8) | 7 (7–9) |
Gleason score ⩾8 at initial diagnosis, n (%) | 26 (41.9)b | 86 (45.3)c |
Type of disease progression at study entry, n (%) | ||
PSA progression only | 27 (41.5) | 69 (34.5) |
Radiographic progression with PSA | 33 (50.8) | 87 (43.5) |
Radiographic progression without PSA | 3 (4.6) | 41 (20.5) |
No disease progression per protocol | 2 (3.1) | 3 (1.5) |
Measureable disease, n (%) | 46 (70.8) | 106 (53.0) |
Disease localization at screening, n (%) | ||
Bone only | 16 (24.6) | 61 (30.5) |
Soft-tissue only | 8 (12.3) | 37 (18.5) |
Both bone and soft tissue | 41 (63.1) | 100 (50.0) |
None | 0 | 2 (1.0) |
Distribution of disease at screening, n (%) | ||
Bone | 57 (87.7) | 161 (80.5) |
Lymph node | 42 (64.6) | 115 (57.5) |
Visceral disease (lung or liver) | 11 (16.9) | 21 (10.5) |
Visceral liver | 2 (3.1) | 8 (4.0) |
Visceral lung | 9 (13.8) | 13 (6.5) |
Other soft tissue | 15 (23.1) | 35 (17.5) |
Baseline use of corticosteroids, n (%) | 2 (3.1) | 8 (4.0) |
Prior antiandrogen use, n (%) | 57 (87.7) | 176 (88.0) |
Prior radiotherapy, n (%) | 25 (38.5) | 95 (47.5) |
Prior surgery, n (%) | 38 (58.5) | 108 (54.0) |
Prior radical prostatectomy | 15 (23.1) | 53 (26.5) |
