Table 1.
Baseline disease characteristics (safety analysis set)
| N = 33 | |
|---|---|
| Years since diagnosis to first dose | |
| Mean (SD) | 8.6 (6.57) |
| Median (range) | 6.7 (1, 32) |
| Stage at diagnosis, n (%) | |
| Primary tumor (T) stage | |
| T1–T4 | 23 (69.7 %) |
| TX | 7 (21.2 %) |
| Unknown/not applicable | 3 (9.1 %) |
| Regional lymph nodes (N) Stage, n (%) | |
| N0–N3 | 11 (33.3 %) |
| NX | 17 (51.5 %) |
| Unknown/not applicable | 5 (15.2 %) |
| Metastasis (M) stage at diagnosis, n (%) | |
| M0 | 8 (24.2 %) |
| M1 (M1, M1a, M1b, M1c) | 15 (45.5 %) |
| MX | 8 (24.2 %) |
| Unknown/not applicable | 2 (6.1 %) |
| Gleason total score at diagnosis, n (%) | |
| <7 | 3 (9.1 %) |
| 7a | 16 (48.5 %) |
| >7 | 11 (33.3 %) |
| Unknown | 3 (9.1 %) |
| PSA (ng/mL) at initial diagnosisb | |
| Mean (SD) | 213.7 (538.28) |
| Median (range) | 11.7 (2, 2183) |
| Extent of disease, n (%) | |
| Bone only | 14 (42.4 %) |
| Visceral disease only | 1 (3.0 %) |
| Bone and soft tissue (node only) | 8 (24.2 %) |
| Bone and visceral disease | 4 (12.1 %) |
| Bone, soft tissue (node only), and visceral disease | 3 (9.1 %) |
| Soft tissue only (node only) | 1 (3.0 %) |
| Soft tissue (node only) and visceral disease | 2 (6.1 %) |
| ECOG status, n (%) | |
| 0 | 26 (78.8 %) |
| 1 | 7 (21.2 %) |
| MUGA scan/echocardiogram, n (%) | |
| Normal | 30 (90.9 %) |
| Abnormal-NCS | 3 (9.1 %) |
| Prior chemotherapy, n (%) | |
| Yes | 9 (27 %)c |
| No | 24 (73 %) |
| Prior radiotherapy, n (%) | |
| Yes | 23 (70 %) |
| No | 9 (27 %) |
| Unknown | 1 (3 %) |
| Prior orchiectomy, n (%) | |
| Yes | 5 (15 %) |
| No | 28 (85 %) |
| Prior therapy with ketoconazole or aminoglutethimide, n (%) | |
| Yes | 6 (18 %) |
| No | 27 (82 %) |
| Number of prior chemotherapies, mean (SD) | 1.0 (0.00) |
ECOG Eastern Cooperative Oncology Group, MUGA Multi-gated Acquisition Scan, NCS non-clinically significant, PSA prostate-specific antigen
aOne patient with total Gleason grade of 7 and unknown first and second Gleason grade is included in this category
b n = 25,
cAll 9 patients were on docetaxel