Table 1.
Baseline patient and disease characteristics.
| Characteristic | N | Median (q1-q3) or % |
|---|---|---|
| Age at baseline (years) | 58 | 68 (61-76) |
| ECOG performance status | ||
| 0 | 42 | 72.4% |
| 1 | 16 | 27.6% |
| Body mass index (kg/m2) | 58 | 30.3 (27.5-31.1) |
| Gleason score at diagnosis | ||
| ≤ 6 | 5 | 8.6% |
| 7 | 22 | 37.9% |
| ≥ 8 | 27 | 45.0% |
| Unknown | 4 | 6.9% |
| PSA at diagnosis (ng/mL) | 53 | 12.3 (7.1-45.4) |
| Prior chemotherapy | 16 | 27.6% |
| Prior ketoconazole | 4 | 6.9% |
| Prior enzalutamide | 6 | 10.3% |
| Presence of metastases at baseline | 53 | 91.4% |
| Sites of metastasis | ||
| Bone | 50 | 86.2% |
| Lymph nodes | 19 | 32.8% |
| Lung | 2 | 3.4% |
| Liver | 1 | 1.7% |
| Laboratory data at baseline | ||
| PSA (ng/mL) | 58 | 15.8 (4.4-49.4) |
| Alkaline phosphatase (U/L) | 58 | 84 (63, 119) |
| Calcium (mg/dL) | 58 | 9.4 (9.1-9.7) |
| Hemoglobin (g/dL) | 58 | 13.0 (12.1-13.8) |
| Platelets (K/UL) | 58 | 210 (182-244) |
| HgA1c (%) | 58 | 5.7 (5.4-6.1) |
| Baseline anti-hypertensive use | 26 | 44.8% |
| 1 agent | 15 | 57.7% |
| 2 agents | 8 | 30.8% |
| 3 agents | 3 | 11.5% |
ECOG=Eastern Oncology Cooperative Group, PSA=prostate specific antigen.