Characteristics of Study Population at Baseline
| Characteristic | Overall (n = 43) | 6.0 GBq (n = 14) | 7.4 GBq (n = 29) |
|---|---|---|---|
| Age (y) | 74 (68–78) | 76 (70–79) | 72 (65–78) |
| Time since diagnosis of PCa (y) | 7 (4–17) | 8 (5–17) | 7 (4–15) |
| Gleason grade group at diagnosis* | |||
| ≥4 | 25 (64%) | 9 (69%) | 16 (62%) |
| PSA (ng/mL) | 27.4 (9.5–115.6) | 31.3 (12.6–160.2) | 26.1 (9.5–124.4) |
| PSA doubling time (mo) | 1.5 (1.0–2.3) | 1.3 (1.0–1.7) | 1.8 (1.0–3.2) |
| Total alkaline phosphatase (U/I) | 87 (67–125) | 82 (60–175) | 94 (69–117) |
| Hemoglobin (g/dL) | 12.0 (10.9–13.2) | 12.1 (11.2–12.9) | 11.6 (10.8–13.3) |
| Platelets (103/mL) | 208 (160–245) | 207 (163–356) | 208 (158–238) |
| ECOG performance status | |||
| 0 | 13 (30%) | 8 (57%) | 5 (17%) |
| 1 | 21 (49%) | 4 (29%) | 17 (59%) |
| 2 | 9 (21%) | 2 (14%) | 7 (24%) |
| Pain at baseline (BPI score) | |||
| No pain | 21 (49%) | 4 (28%) | 17 (58%) |
| Mild (1–4) | 11 (26%) | 5 (36%) | 6 (21%) |
| Moderate to severe (5–10) | 11 (26%) | 5 (36%) | 6 (21%) |
| Previous mCRPC systemic treatments | |||
| Chemotherapy regimen lines | |||
| 0 | 11 (26%) | 4 (29%) | 7 (24%) |
| 1 | 10 (23%) | 4 (29%) | 6 (21%) |
| 2 | 12 (28%) | 3 (21%) | 9 (31%) |
| ≥3 | 10 (23%) | 3 (7%) | 7 (24%) |
| Abiraterone | 41 (95%) | 13 (93%) | 28 (97%) |
| Enzalutamide | 37 (86%) | 13 (93%) | 24 (83%) |
| Abiraterone + enzalutamide | 35 (82%) | 12 (86%) | 23 79%) |
| 223Ra | 14 (33%) | 4 (29%) | 10 (35%) |
| Prior lines of mCRPC systemic treatment | |||
| 1 | 4 (9%) | 1 (7%) | 3 (10%) |
| ≥2 | 39 (91%) | 13 (93%) | 26 (90%) |
| ≥3 | 31 (72%) | 10 (71%) | 21 (72%) |
| ≥4 | 25 (58%) | 8 (57%) | 17 (59%) |
| Extent of disease on PSMA-PET | |||
| ≤20 metastases | 14 (33%) | 4 (29%) | 10 (34%) |
| 2 metastases | 29 (67%) | 10 (71%) | 19 (66%) |
| Sites of disease on PSMA PET | |||
| Node only (N1 or M1a) | 3 (7%) | 1 (7%) | 2 (7%) |
| Bone only (M1b) | 9 (21%) | 3 (21%) | 6 (21%) |
| Node + bone (M1b and [N1 or M1a]) | 15 (35%) | 7 (50%) | 8 (28%) |
| Visceral (M1c with/without any other site)† | 15 (35%) | 3 (21%) | 12 (41%) |