Table 1.
Patient baseline demographics and disease characteristics
| Characteristic | Value |
|---|---|
| Total assessable patients (n) | 48 |
| Age (y) | |
| Median | 68 |
| Range | 47–85 |
| Age ≥65 y (n) | 36 (75) |
| Race/ethnicity (n) | |
| White | 46 (96) |
| Black | 1 (2) |
| Other | 1 (2) |
| Interval since diagnosis (mo) | |
| Median | 79 |
| Range | 13–238 |
| ECOG performance status (n) | |
| 0 | 35 (73) |
| 1 | 13 (27) |
| PSA (ng/mL) | n = 48 |
| Median | 43.6 |
| Range | 5.7–471 |
| uNTX (nM/mmol creatinine) | n = 46 |
| Median | 46.0 |
| Range | 8.0–535.0 |
| BAP (U/L) | n = 47 |
| Median | 35.0 |
| Range | 14.0–563.0 |
| Previous therapy (n) | |
| Surgery | 32 (67) |
| Radiotherapy | 37 (77) |
| Bisphosphonates | 12 (25) |
| RECIST-evaluable disease (n) | 20 (42) |
| Bone metastases (n) | 34 (71) |
| Disease sites, target lesions (n) | |
| Lymph node | 18 (38) |
| Pelvis | 1 (2) |
| Prostate mass | 1 (2) |
| Skin/soft tissue | 1 (2) |
| Visceral, lung | 1 (2) |
| Visceral, liver | 1 (2) |
ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen; RECIST, Response Evaluable Criteria in Solid Tumors; uNTX, urine N-telopeptide; BAP, bone alkaline phosphatase.
Data in parentheses are percentages.