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 |