Summary of Selected Phase II–III Randomized Trials of 223Ra and 177Lu-Based RLTs in Prostate Cancer
| Trial | Design | Dosage | Inclusion criteria | Patients (n) | Result |
|---|---|---|---|---|---|
| ALSYMPCA (44) | Phase III RCT; standard of care + 6 doses of 223Ra vs. standard of care | 50 kBq per kilogram of body weight every 4 wk | Progressive mCRPC and ≥2 symptomatic bone metastases with no known visceral metastases | 921 | OS, 14.9 vs. 11.3 mo; time to first symptomatic skeletal event, 15.6 vs. 9.8 mo; meaningful improvements in pain (30.2% vs. 20.1%) |
| VISION (51) | Phase III RCT; 4–6 cycles of 177Lu-PSMA-617 vs. standard of care | 7.4 GBq every 6 wk | Progressive mCRPC ≥1 PSMA-positive lesion with uptake greater than liver parenchyma and no PSMA-negative lesions | 831 | Improved OS, median 15.3 mo vs. 11.3 mo; radiographic PFS, median 8.7 vs. 3.4 mo; time to first symptomatic skeletal event or death, median of 11.5 vs. 6.8 mo |
| TheraP (53) | Phase II RCT; op to 6 cycles of 177Lu-PSMA-617 vs. cabazitaxel | 8.5 GBq for first cycle, with 0.5-GBq decrease per subsequent cycle (6 wk between cycles) | Progressive mCRPC ≥1 PSMA-positive lesion with SUVmax ≤20 (with all other PSMA-avid sites having SUVmax of ≥10) and nondiscordant findings between PSMA and 18F-FDG PET/CT | 200 | PSA response rate (50% reduction or more), 66% vs. 37%; progression was delayed with 177Lu-PSMA-617 (HR, 0.63) |
RCT = randomized controlled trial.