Table 1.
Demographic and baseline disease characteristics.
| 1 × 108 CFU n = 6 | 1 × 109 CFU n = 20 | Total n = 26 | |
|---|---|---|---|
| Median age, years (range) | 74 (58–77) | 65 (46–85) | 67 (46–85) |
| Race, n (%) | |||
| White | 5 (83) | 20 (100) | 25 (96) |
| Black or African American | 1 (17) | 0 | 1 (4) |
| ECOG PS, n (%) | |||
| 0 | 2 (33) | 7 (35) | 9 (35) |
| 1 | 4 (67) | 13 (65) | 17 (65) |
| Time from initial diagnosis, years (range) | 5 (1–18) | 6 (1–17) | 6 (1–18) |
| Gleason score, n (%) | |||
| <7 | 1 (17) | 2 (10) | 3 (12) |
| 7 | 2 (33) | 3 (15) | 5 (19) |
| ≥8 | 3 (50) | 13 (65) | 16 (62) |
| Unknown | 0 | 2 (10) | 2 (8) |
| Extent of disease at entry, n (%) | |||
| Bone | 4 (67) | 19 (95) | 23 (89) |
| Bone only | 1 (17) | 6 (30) | 7 (27) |
| Soft tissue or node | 2 (33) | 14 (70) | 16 (62) |
| Other | 3 (50) | 5 (25) | 8 (31) |
| Evidence of disease progression, n (%) | |||
| PSA | 0 | 14 (74) | 14 (56) |
| Radiographic | 6 (100) | 11 (58) | 17 (68) |
| Laboratory parameters | |||
| Median hemoglobin, g/dL (range) | 10 (9–13) | 11 (9–14) | 11 (9–14) |
| Median alkaline phosphatase, U/L (range) | 178 (74–633) | 88 (25–1015) | 96 (25–1015) |
| Median lactate dehydrogenase, U/L (range) | 849 (314–2719) | 370 (99–2203) | 401 (99–2719) |
CFU colony-forming unit, ECOG PS Eastern Cooperative Oncology Group performance status, PSA prostate-specific antigen.