Table 2.
Patient demographics and clinical characteristics at study entry.
| Characteristic | Patients (n = 1465) |
|---|---|
| Age, years | 73 (67–79) |
| ECOG PS | |
| 0 | 441 (30%) |
| 1 | 727 (50%) |
| ≥2 | 220 (15%) |
| Missing | 77 (5%) |
| Time from diagnosis of CRPC to study entry, months (n = 744) | 13 (3–27) |
| Time from initial diagnosis of bone metastases to study entry, months (n = 994) | 23 (12–42) |
| Prior interventions | |
| Radiation therapy to prostate | 486 (33%) |
| Surgery | 291 (20%) |
| Systemic anticancer therapya | 900 (61%) |
| No therapy to prostate | 709 (48%) |
| Missing resection status | 26 (2%) |
| Extent of disease (n = 1349 with bone scan at baseline)b | |
| <6 lesions | 259 (19%) |
| 6–20 lesions | 636 (47%) |
| >20 lesions | 270 (20%) |
| Superscan | 81 (6%) |
| Extent of disease not documented | 73 (5%) |
| Metastases | |
| Bone metastases only | 1193 (81%) |
| Bone metastases plus lymph nodes | 183 (13%) |
| Bone metastases plus lymph nodes plus other metastases | 25 (2%) |
| Bone metastases plus other metastases, excluding lymph nodes | 64 (4%) |
| Non-bone metastasis location (in >1% of patients)c | |
| Lymph node | 208 (14%) |
| Retroperitoneal | 64 (4%) |
| Pelvic | 49 (3%) |
| Para-aortic | 40 (3%) |
| Iliac | 37 (3%) |
| Mediastinal | 29 (2%) |
| Lung | 37 (3%) |
| Bladder | 17 (1%) |
| Liver | 16 (1%) |
| Laboratory valuesd | |
| Alkaline phosphatase, U/L (n = 1048) | 135 (82–263) |
| Haemoglobin, g/dL (n = 1300) | 12 (11–13) |
| Lactate dehydrogenase, U/L (n = 555) | 269 (200–419) |
| Prostate-specific antigen, ng/mL (n = 1053) | 59 (16–201) |
| Mean BPI-SF score | |
| Pain severity (n = 1312) | 3.0 (2.2) |
| Pain at its worst (n = 1320) | 4.1 (2.9) |
| BPI-SF “pain at its worst” score (n = 1320) | |
| 0 | 217 (16%) |
| 1 | 76 (6%) |
| 2 | 134 (10%) |
| 3 | 150 (11%) |
| 4 | 130 (10%) |
| 5 | 166 (13%) |
| 6 | 119 (9%) |
| 7 | 123 (9%) |
| 8 | 130 (10%) |
| 9 | 45 (3%) |
| 10 | 30 (2%) |
Data are median (IQR), mean (SD), or n (%). Percentages may not total 100 because of missing data and/or rounding. BPI-SF = Brief Pain Inventory Short Form. CRPC = castration-resistant prostate cancer. ECOG PS = Eastern Cooperative Oncology Group performance status. IQR = interquartile range. SD = standard deviation.
Systemic anticancer therapies included docetaxel, cabazitaxel, abiraterone acetate, enzalutamide, and sipuleucel-T.
The total includes 30 patients who had a bone scan with negative findings; these patients had a history of bone metastases identified on other imaging.
Location of other visceral metastases: abdomen (one), adrenal gland (seven), brain (two), breast (one), kidney (three), pelvis (one), peritoneum (one), pleura (one), prostate (one), rectum (four), skull base (one), soft tissue (two), spinal cord (two), T10 vertebra (one), thyroid gland (one), urethra (one).
Laboratory tests were done locally, with varying normal ranges.