Table 1.
Baseline characteristics for the prostate cancer patients
| Characteristic | Phase I (n = 10) | Phase II (n = 27) | Total (n = 37) |
|---|---|---|---|
| Age, y | |||
| Median | 70 | 73 | 70 |
| Range | 59–76 | 52–87 | 52–87 |
| Karnofsky Performance Status | |||
| Median | 90 | 80 | 90 |
| Range | 80–90 | 70–90 | 70–90 |
| Baseline PSA, ng/mL | |||
| Median | 59 | 197 | 194 |
| Range | 7–1013 | 1–5447 | 1–5447 |
| Primary Gleason score | |||
| Median | 7 | 8 | 8 |
| Range | 6–9 | 5–9 | 5–9 |
| Baseline LDH, IU/L | |||
| Median | 204 | 207 | 207 |
| Range | 157–336 | 139–615 | 139–615 |
| Primary treatment, n | |||
| Surgery | 0 | 6 | 6 |
| Radiation | 4 | 10 | 14 |
| Untreated | 6 | 11 | 17 |
| Sites of disease, n | |||
| Bone only | 5 | 12 | 17 |
| Soft tissue only | 0 | 3 | 3 |
| Bone and soft tissue | 5 | 12 | 17 |
| Prior chemotherapy regimens, n | |||
| 0 | 4 | 10 | 14 |
| 1 | 3 | 6 | 9 |
| 2 | 1 | 2 | 3 |
| ≥ 3 | 2 | 9 | 11 |
Abbreviations: PSA, prostate-specific antigen; LDH, lactate dehydrogenase.