2021 September 16; 385(12): 1091–1103 | O. Sartor#, J. de Bono, K.N. Chi, K. Fizazi, K. Herrmann, K. Rahbar, S.T. Tagawa, L.T. Nordquist, N. Vaishampayan, G. El-Haddad, C.H. Park, T.M. Beer, A. Armour, W.J. Pérez-Contreras, M. DeSilvio, E. Kpamegan, G. Gericke, R.A. Messmann, M.J. Morris#, B.J. Krause#
The VISION trial evaluated the efficacy and safety of 177Lu-PSMA-617, a radioligand therapy targeting prostate-specific membrane antigen (PSMA), in patients with metastatic castration-resistant prostate cancer (mCRPC). The study was an international, open-label, phase 3 trial that included 831 patients who had received at least one androgen-receptor pathway inhibitor and one or two taxane regimens. Patients were randomly assigned in a 2:1 ratio to receive 177Lu-PSMA-617 plus protocol-permitted standard care or standard care alone. The primary endpoints were imaging-based progression-free survival and overall survival, with alternate primary endpoints being overall survival and time to first symptomatic skeletal event. Key secondary endpoints included objective response, disease control, and health-related quality of life. The results showed that 177Lu-PSMA-617 plus standard care significantly prolonged imaging-based progression-free survival (median, 8.7 vs. 3.4 months; hazard ratio, 0.40; P<0.001) and overall survival (median, 15.3 vs. 11.3 months; hazard ratio, 0.62; P<0.001) compared to standard care alone. The incidence of grade 3 or higher adverse events was higher in the 177Lu-PSMA-617 group (52.7% vs. 38.0%), but quality of life was not adversely affected. The study concluded that 177Lu-PSMA-617 prolonged imaging-based progression-free survival and overall survival in patients with mCRPC when added to standard care.The VISION trial evaluated the efficacy and safety of 177Lu-PSMA-617, a radioligand therapy targeting prostate-specific membrane antigen (PSMA), in patients with metastatic castration-resistant prostate cancer (mCRPC). The study was an international, open-label, phase 3 trial that included 831 patients who had received at least one androgen-receptor pathway inhibitor and one or two taxane regimens. Patients were randomly assigned in a 2:1 ratio to receive 177Lu-PSMA-617 plus protocol-permitted standard care or standard care alone. The primary endpoints were imaging-based progression-free survival and overall survival, with alternate primary endpoints being overall survival and time to first symptomatic skeletal event. Key secondary endpoints included objective response, disease control, and health-related quality of life. The results showed that 177Lu-PSMA-617 plus standard care significantly prolonged imaging-based progression-free survival (median, 8.7 vs. 3.4 months; hazard ratio, 0.40; P<0.001) and overall survival (median, 15.3 vs. 11.3 months; hazard ratio, 0.62; P<0.001) compared to standard care alone. The incidence of grade 3 or higher adverse events was higher in the 177Lu-PSMA-617 group (52.7% vs. 38.0%), but quality of life was not adversely affected. The study concluded that 177Lu-PSMA-617 prolonged imaging-based progression-free survival and overall survival in patients with mCRPC when added to standard care.