Table 1.
Various trials on 177Lu-PSMA617 in metastatic castration resistance prostate cancer
| Study | VISION trial[1] | TheraP trial[2] | Yadav et al.[3] |
|---|---|---|---|
| Interventional drug | 177Lu-PSMA617 | 177Lu-PSMA617 | 177Lu-PSMA617 |
| Control | Standard therapy alone | Cabazitaxel | - |
| Study population | Progressive mCPRC who already received ADT along with taxane regimen | mCRPC patients who already received ADT | Progressive mCRPC patients on ADT and/or taxane chemotherapy |
| Study design | Phase 3, RCT | Phase 2 unblinded RCT | Single-arm prospective study |
| Sample size | 831 | 200 | 90 |
| Allotment | 2:1 | 1:1 | - |
| Primary outcome | OS IB-PFS |
PSA response | OS |
| IB-PFS | 8.7 months versus 3.4 months | ||
| OS | 15.3 months versus 11.3 months | Yet to report | 14 months |
| PSA response rate | 46% versus 7.1% (>50% response) 33% versus 2% (>80% response) |
66% versus 37% | 45% at the end of assessment |
| Adverse events (Grade 3-4) | 52.7% versus 38% | 33% versus 45% | No adverse events |
IB-PFS=Imaging-based progression-free survival, OS=Overall survival, RCT=Randomized control trial, ADT=Androgen deprivation therapy, mCRPC=Metastatic castration resistance prostate cancer, PSA=Prostate-specific antigen