Table 1.
Demographics and baseline disease characteristics
| Characteristics | Site 1a (n = 10) | Site 2b (n = 12) | All patients (N = 22) |
|---|---|---|---|
| Median age (range), years | 76.0 (46.0–85.0) | 68.5 (47.0–75.0) | 70.5 (46.0–85.0) |
| ≥75 years, n (%) | 6 (60.0) | 1 (8.3) | 7 (31.8) |
| Race, n (%) | |||
| Black or African American | 0 | 3 (25.0) | 3 (13.6) |
| White | 10 (100.0) | 9 (75.0) | 19 (86.4) |
| Ethnicity, n (%) | |||
| Not Hispanic or Latino | 10 (100.0) | 12 (100.0) | 22 (100.0) |
| ECOG performance status 0, n (%) | 4 (40.0) | 2 (16.7) | 6 (27.3) |
| ECOG performance status 1, n (%) | 6 (60.0) | 10 (83.3) | 16 (72.7) |
| Median weight (range), kg | 77.3 (66.0–102.4) | 90.3 (75.3–106.1) | 86.5 (66.0–106.1) |
| Median body mass index (range), kg/m2 | 24.5 (21.7–34.8) | 28.2 (23.7–35.0) | 26.9 (21.7–35.0) |
| Gleason score 8–10, n (%) | 7 (70.0) | 8 (66.7) | 15 (68.2) |
| Median PSA (range), ng/mL | 57.1 (1.8–527.5) | 58.8 (1.9–585.0) | 57.9 (1.8–585.0) |
| Median hemoglobin (range), g/L | 130.0 (117.0–140.0) | 120.0 (98.0–148.0) | 125.0 (98.0–148.0) |
| Median alkaline phosphatase (range), U/L | 80.5 (45.0–547.0) | 112.0 (51.0–1432.0) | 90.5 (45.0–1432.0) |
| Prior opiate use, n (%) | 1 (10.0) | 7 (58.3) | 8 (36.4) |
| Prior therapy for localized disease, n (%) | |||
| Prostatectomy | 4 (40.0) | 3 (25.0) | 7 (31.8) |
| Transurethral resection of the prostate | 1 (10.0) | 1 (8.3) | 2 (9.1) |
| External beam radiotherapy | 9 (90.0) | 5 (41.7) | 14 (63.6) |
| Brachytherapy | 0 | 1 (8.3) | 1 (4.5) |
| Visceral disease at screening, n (%) | |||
| Lung | 0 | 2 (16.7) | 2 (9.1) |
| Liver | 0 | 2 (16.7) | 2 (9.1) |
| Median time from initial diagnosis (range), mo | 73.9 (15.2–209.0) | 45.7 (4.0–141.3) | 64.7 (4.0–209.0) |
| Median no. of prior systemic therapies (range)c | 3.5 (2–8) | 2 (1–4) | 2 (1–8) |
NOTE: Percentages are based on number of patients in the safety population.
a
MSKCC.
b
Virginia Oncology Associates.
c
Prior therapy data provided by the study sites.