Lutetium-177 (177Lu)-prostate-specific mem- brane antigen (PSMA)-617 radioligand therapy added to standard care is beneficial for patients with advanced PSMA-positive metastatic castration-resistant prostate cancer, according to a study published in the New England Journal of Medicine. Investigators conducted an inter- national, phase III trial involving patients with metastatic castration-resistant prostate cancer previously treated with at least one androgen receptor-pathway inhibitor and one or two taxane regimens. A total of 831 patients were randomly assigned to receive 177Lu-PSMA-617 plus protocol-permitted standard care, which excluded chemotherapy, immunotherapy, radium-223, and investigational drugs, or stan- dard care alone. Patients were followed for a median of 20.9 months. Compared with stan- dard care, 177Lu-PSMA-617 plus standard care significantly prolonged imaging-based progression-free survival (median, 8.7 vs 3.4 months; hazard ratio [HR] for progression or death, 0.40) and overall survival (median, 15.3 vs 11.3 months; HR for death, 0.62). 177Lu-PSMA-617 was significantly favored for all key secondary end points. A higher incidence of adverse events of grade III or above was seen with versus without 177Lu- PSMA-617 (52.7% vs 38.0%), while quality of life was not adversely affected.
