Baseline Characteristics (ITT Population)
| Characteristic | 6.0 GBq arm (n = 28) | 7.4 GBq arm (n = 43) | Overall (n = 71) |
|---|---|---|---|
| Age (y) | |||
| Mean (SD) | 72.1 (8.39) | 69.1 (8.62) | 70.3 (8.60) |
| Minimum; maximum | 55; 95 | 54; 84 | 54; 95 |
| <65 y (n) | 4 (14.3%) | 13 (30.2%) | 17 (23.9%) |
| ≥65 y (n) | 24 (85.7%) | 30 (69.8%) | 54 (76.1%) |
| Race/ethnicity (n) | |||
| Asian | 1 (3.6%) | 1 (2.3%) | 2 (2.8%) |
| Black/African American | 0 | 1 (2.3%) | 1 (1.4%) |
| Hispanic/Latino | 0 | 1 (2.3%) | 1 (1.4%) |
| White | 26 (92.9%) | 40 (93.0%) | 66 (92.9%) |
| Other | 1 (3.6%) | 0 | 1 (1.4%) |
| Time since initial prostate cancer diagnosis (y) | |||
| Mean (SD) | 8.06 (7.323) | 8.06 (7.152) | 8.06 (7.156) |
| Minimum; maximum | 0.7; 27.2 | 0.3; 25.9 | 0.3; 27.2 |
| Initial Gleason score, categorized (n) | |||
| 4–7 | 7 (25.0%) | 13 (30.2%) | 20 (28.2%) |
| 8–10 | 20 (71.4%) | 26 (60.5%) | 46 (64.8%) |
| Unknown | 1 (3.6%) | 4 (9.3%) | 5 (7.0%) |
| Baseline PSA doubling time (mo) | |||
| n | 26 | 41 | 67 |
| Mean (SD) | 4.35 (7.131) | 3.89 (3.977) | 4.07 (5.376) |
| Median | 1.91 | 2.46 | 2.07 |
| Q1; Q3 | 1.18; 3.38 | 1.41; 4.90 | 1.22; 4.90 |
| Minimum; maximum | 0.0; 31.4 | 0.0; 20.7 | 0.0; 31.4 |
| ≤6 (n) | 21 (80.8%) | 33 (80.5%) | 54 (80.6%) |
| >6 (n) | 5 (19.2%) | 8 (19.5%) | 13 (19.4%) |
| Baseline PSA (ug/L) | |||
| n | 12 | 19 | 31 |
| Mean (SD) | 208.86 (391.804) | 287.92 (830.231) | 257.32 (686.578) |
| Median | 46.03 | 19.34 | 23.66 |
| Q1; Q3 | 11.28; 99.35 | 5.34; 68.00 | 5.59; 93.20 |
| Minimum; maximum | 0.6; 1166.0 | 1.9; 3499.0 | 0.6; 3499.0 |
| Number of prior chemotherapies per patient | |||
| n | 22 (78.6%) | 36 (83.7%) | 58 (81.7%) |
| Median | 2.0 | 2.0 | 2.0 |
| Q1; Q3 | 1.0; 3.0 | 1.0; 3.0 | 1.0; 3.0 |
| Minimum; maximum | 1; 7 | 1; 5 | 1; 7 |
| Type of prior chemotherapies per patient (n) | |||
| Cabazitaxel | 9 (32.1%) | 17 (39.5%) | 26 (36.6%) |
| Docetaxel | 21 (75.0%) | 33 (76.7%) | 54 (76.1%) |
| Other | 9 (32.1%) | 18 (41.9%) | 27 (38.0%) |
| Type of other prior systemic treatment (n) | |||
| Abiraterone | 26 (92.9%) | 41 (95.3%) | 67 (94.4%) |
| Enzalutamide | 21 (75.0%) | 34 (79.1%) | 55 (77.5%) |
| Hormonal therapy | 22 (78.6%) | 39 (90.7%) | 61 (85.9%) |
| Standard ADT | 19 (67.9%) | 22 (51.2%) | 41 (57.7%) |
| 223Ra | 5 (17.9%) | 14 (32.6%) | 19 (26.8%) |
| Other | 20 (71.4%) | 31 (72.1%) | 51 (71.8%) |