Table 1.
Baseline patient characteristics
| [177Lu]Lu- PSMA I&T |
[177Lu]Lu-PSMA-617 | P-value | |
|---|---|---|---|
| Clinical variables | |||
| Age at first cycle of PSMA RLT (years)# | 71 (46–84) | 70 (43–86) | 0.89 |
| Time period between initial diagnosis and 1st RLT (months) | 64.0 (9–246) | 63 (4–241) | 0.37 |
| Treatment cycles per patient | 3 (2–8) | 3 (2–8) | 0.77 |
| Cumulative activity (GBq) | 18.0 (10.4–49.2) | 19.0 (7.9–45.8) | 0.21 |
| Activity per cycle (GBq) | 6.0 (3.9–6.8) | 6.2 (3.9–9.6) | 0.11 |
| Gleason score# | 9 (6–10) | 9 (6–10) | 1.0 |
| Baseline laboratory values | |||
| PSA (ng/ml)# | 168 (5.0–3130) | 145 (3.6–2360) | 0.16 |
| LDH (37 °C U/l) | 269 (118–1105) | 274 (147–2582) | 0.13 |
| Leukocytes (Tsd/µl) | 6.0 (2.7–15.3) | 6.4 (1.5–13.8) | 0.46 |
| Haemoglobin (g/dl) | 11.5 (8.2–16.1) | 11.6 (7.9–13.8) | 0.34 |
| Platelets (Tsd/µl) | 245.0 (76.0–590) | 226.0 (45.0–562) | 0.27 |
| Creatinine (mg/dl) | 0.92 (0.60–1.92) | 0.82 (0.48–2.12) | 0.08 |
| AST (37 °C U/l) | 28.0 (15.0–62.0) | 28.0 (14.0–114.0) | 0.70 |
| Gamma-GT (37 °C U/l) | 32.1 (12.8–307.1) | 33.0 (12.0–1130) | 0.48 |
| AP (37 °C U/l) | 130 (31.0–1499) | 139 (45.0–982) | 0.65 |
| Previous Treatments (%) | |||
| Radical prostatectomy | 40.0 | 41.8 | 1.0 |
| Primary radiation therapy to the prostate | 16.4 | 18.2 | 1.0 |
| Adjuvant radiation therapy | 21.8 | 14.6 | 0.46 |
| Salvage radiation therapy | 18.2 | 9.1 | 0.27 |
| Antihormonal treatment | 100 | 100 | 1.0 |
| Second generation antihormonal treatment (Abiraterone /Enzalutamide) | 90.9 | 89.1 | 1.0 |
| Chemotherapy# | 72.4 | 72.4 | 1.0 |
| Comorbidities (%) | |||
| Arterial hypertension | 56.4 | 27.3 | 0.004 |
| Preexisting renal disease | 18.2 | 9.1 | 0.27 |
| Diabetes mellitus | 16.4 | 3.6 | 0.05 |
Abbreviations: PSA, prostate specific antigen; LDH, lactate dehydrogenase; AST, aspartate aminotransferase; GammaGT, gamma-glutamyltransferase; AP, alkaline phosphatase
# = matching criteria