Trials LuPSMA[@194579] TheraP[@194580] VISION[@194577]
Study design Single-arm, single-center, phase II trial Multicenter, unblinded, randomized phase II trial International, open-label, randomized, phase III trial
Patient population mCRPC progressed on ADT and taxane chemotherapy (n=30) mCRPC for whom cabazitaxel was considered the next appropriate standard treatment (n=200) mCRPC progressed on ADT and taxane chemotherapy (n=831)
Imaging screening 68Ga-PSMA-11 68Ga-PSMA-11 68Ga-PSMA-11
PSMA-positive lesion Uptake 1.5x greater than that of liver uptake SUV max ≥20 at site of disease and >10 at all other sites Uptake greater than that of liver
PSMA-negative lesion Low uptake
PSMA negative/FDG positive lesion
Low uptake
PSMA negative/FDG positive lesion
Uptake ≤ livera
Treatment
protocol
7.5 GBq every 6 weeks for 4 cycles 6.0–8.5 GBq every 6 weeks for up to 6 cycles 7.4 GBq every 6 weeks for 4 to 6 cycles
Control group - Cabazitaxel Standard of careb
% patients ≥50% PSA decline vs control 57% 66% vs 37% 46% vs 7.1%
Median PFS (months) vs control 7.6 5.1 vs 5.1 8.7 vs 3.4
Median OS (months) vs control 13.5 - 15.3 vs 11.3