Table 2.
Demographic and patient characteristics (ITT population). The data are presented as n (%) unless otherwise noted.
| Arm A (N = 34) | Arm B (N = 34) | |
|---|---|---|
| Age (years) | ||
| Median | 74 | 76 |
| Range | 60–83 | 60–86 |
| ECOG | ||
| 0 | 26 (76) | 28 (82) |
| 1 | 7 (21) | 6 (18) |
| 2 | 1 (3) | 0 (0) |
| Gleason score at diagnosis | ||
| 5 | 1 (3) | 1 (3) |
| 6 | 3 (9) | 4 (12) |
| 7 | 11 (32) | 9 (27) |
| 8 | 7 (21) | 8 (23) |
| 9 | 8 (23) | 8 (23) |
| 10 | 1 (3) | 1 (3) |
| Previous cancer therapy | ||
| Prior prostatectomy | 17 (50) | 10 (29) |
| Prior radiotherapy | 15 (44) | 14 (42) |
| Hormonal therapy | 34 (100) | 34 (100) |
| Hormone therapy | ||
| Leuprorelin | 16 (47) | 18 (53) |
| Goserelin | 0 (0) | 2 (6) |
| Buserelin | 6 (18) | 3 (9) |
| Pamorelin | 3 (9) | 4 (12) |
| Degarelix | 4 (12) | 0 (0) |
| Abarelix | 0 (0) | 0 (0) |
| Unknown | 5 (15) | 7 (21) |
| Time last LHRH to treatment start (days) | ||
| N | 31 | 33 |
| Median | 106 | 97 |
| Range | 31–1318 | 16–270 |
| Serum testosterone level at baseline (ng/ml) | ||
| N | 34 | 33 |
| Median | 0.08 | 0.06 |
| Range | 0.029–4.210a | 0.029–0.429 |
| Metastases at baseline | ||
| Bone only | 14 (41) | 15 (44) |
| Lymph node/soft tissue | 3 (9) | 3 (9) |
| Bone and Lymph node/soft tissue/prostate | 16 (47) | 15 (44) |
| No metastases | 1 (3) | 1 (3) |
| Measurable disease (including primary) | ||
| Yes | 20 (59) | 15 (44) |
| No | 14 (41) | 19 (56) |
| Baseline BPI-score | ||
| 0–1 | 29 (85) | 29 (85) |
| 2–3 | 3 (9) | 5 (15) |
| >3 | 2 (6) | 0 (0.0) |
| Analgetic use at baseline | ||
| No | 27 (79) | 23 (68) |
| Yes | 7 (21) | 11 (32) |
| Baseline hemoglobin level (g/dl) | ||
| N | 34 | 34 |
| Median | 13.1 | 13.6 |
| Range | 8.6–15.5 | 10.6–15.5 |
| Baseline LDH (IU/L) | ||
| N | 30 | 32 |
| Median | 223.5 | 223.2 |
| Range | 126–635 | 150–550 |
| Baseline alkaline phosphatase (IU/L) | ||
| N | 33 | 32 |
| Median | 118 | 87.2 |
| Range | 48–319 | 36–1625 |
| Baseline PSA (ng/ml) | ||
| N | 34 | 34 |
| Median | 31.9 | 19.50 |
| Range | 0.17–313.2 | 1.97–1680 |
aOne patient was included despite non-castrate levels of testosterone.