Table 1.
Baseline patient characteristics (ITT population)
| Radium-223 monotherapy (n = 22) | Radium-223 + abiraterone/prednisone (n = 24) | Radium-223 + enzalutamide (n = 22) | Total (N = 68) | |
|---|---|---|---|---|
| Median age, years | 72 | 68 | 73 | 71 |
| ECOG PS, n (%) | ||||
| 0 | 10 (45) | 13 (54) | 11 (50) | 34 (50) |
| 1 | 9 (41) | 9 (38) | 11 (50) | 29 (43) |
| Median total ALP, U/l | 96 | 101 | 98 | 99 |
| Median PSA, μg/l | 31 | 17 | 19 | 19 |
| Median time since PC diagnosis, months | 25 | 52 | 48 | 46 |
| Median time since first cancer progression, months | 15 | 32 | 20 | 21 |
| Median time since bone metastasis initial diagnosis, months | 10 | 15 | 22 | 16 |
| Extent of disease, n (%) | ||||
| <6 metastases | 9 (41) | 6 (25) | 6 (27) | 21 (31) |
| 6-20 metastases | 7 (32) | 11 (46) | 12 (55) | 30 (44) |
| >20 lesions | 3 (14) | 5 (21) | 4 (18) | 12 (18) |
| Superscan | 1 (5) | 0 | 0 | 1 (1) |
| Median baseline BSLA, mm2 | 4315 | 7479 | 7516 | 7266 |
| Prior systemic anticancer therapies, n (%)a | ||||
| Sipuleucel-T | 5 (23) | 6 (25) | 3 (14) | 14 (21) |
| Docetaxel | 4 (18) | 3 (13) | 5 (23) | 12 (18) |
| Prior BHA use, n (%) | 8 (42)b | 7 (32)c | 8 (36) | 23 (37)d |
| Denosumab | 7 (37)b | 6 (27)c | 7 (32) | 20 (32)d |
| Zoledronic acid | 1 (5)b | 1 (5)c | 1 (5) | 3 (5)d |
ALP, alkaline phosphatase; BHA, bone health agent; BSLA, bone scan lesion area; ECOG PS, Eastern Cooperative Oncology Group performance status; ITT, intention-to-treat; PC, prostate cancer; PSA, prostate-specific antigen.
a
>15% of patients overall.
b
n = 19.
c
n = 22.
d
n = 63.