Table 1.
Summary of demographics and other baseline characteristics
| Demographic/characteristic | Phase I (N = 9) | Phase II (N = 38) |
|---|---|---|
| Age (years) | ||
| Median | 73.0 | 71.5 |
| Min–max | 62–86 | 50–85 |
| Height (cm) | ||
| Median | 166.0 | 165.7 |
| Min–max | 156.2–174.4 | 153.4–181.0 |
| Weight (kg) | ||
| Median | 71.2 | 65.7 |
| Min–max | 49.2–88.9 | 49.2–93.0 |
| ECOG PSa | ||
| Grade 0 | 8 (88.9) | 25 (65.8) |
| Grade 1 | 1 (11.1) | 13 (34.2) |
| Total Gleason scoreb at initial diagnosisa | ||
| Low, 2–4 | 0 | 0 |
| Medium, 5–7 | 0 | 8 (21.1) |
| High, 8–10 | 9 (100.0) | 29 (76.3) |
| Unknown | 0 | 1 (2.6) |
| Clinical tumor stage (T)c at initial diagnosisa | ||
| TX | 1 (11.1) | 1 (2.6) |
| T0 | 0 | 0 |
| T1 | 0 | 0 |
| T2 | 1 (11.1) | 10 (26.3) |
| T3 | 6 (66.7) | 16 (42.1) |
| T4 | 1 (11.1) | 10 (26.3) |
| Unknown | 0 | 1 (2.6) |
| Clinical lymph node stage at initial diagnosisa | ||
| NX | 2 (22.2) | 1 (2.6) |
| N0 | 3 (33.3) | 14 (36.8) |
| N1 | 4 (44.4) | 22 (57.9) |
| Unknown | 0 | 1 (2.6) |
| Distant metastasis (M)c at initial diagnosisb | ||
| MX | 0 | 1 (2.6) |
| M0 | 3 (33.3) | 17 (44.7) |
| M1 | 6 (66.7) | 19 (50.0) |
| Unknown | 0 | 1 (2.6) |
| Number of bone metastases | ||
| 0 | 3 (33.3) | 8 (21.1) |
| 1 | 1 (11.1) | 1 (2.6) |
| 2–4 | 1 (11.1) | 6 (15.8) |
| 5–9 | 0 | 7 (18.4) |
| ≥10 | 4 (44.4) | 16 (42.1) |
| Anti-androgen withdrawal syndromea | ||
| Yes | 0 | 4 (10.5) |
| Stage of prostate cancera,b | ||
| Localized | 1 (11.1) | 6 (15.8) |
| Locally advanced | 2 (22.2) | 11 (28.9) |
| Metastatic | 6 (66.7) | 19 (50.0) |
| Not classifiable | 0 | 2 (5.3) |
| PSA at baseline (ng/mL) | ||
| Mean (SD) | 634.82 (1403.52) | 174.94 (307.97) |
| Median | 21.60 | 65.80 |
| Duration of disease at screening (months) | ||
| Mean (SD) | 47.36 (22.23) | 63.11 (38.15) |
| Median | 39.93 | 52.83 |
ECOG PS Eastern Cooperative Oncology Group performance status, PSA prostate-specific antigen, SD standard deviation
aNumber (%) of patients
bGleason [27]
cClassified using the TNM classification [28] as follows: localized, T1/2 and (NX or N0) and M0; locally advanced, T3/4 and (NX or N0) and M0 or N1 and M0; metastatic, M1; Not classifiable, others