(HealthDay News) — Lutetium-177 (177Lu)-prostate-specific membrane 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 online June 23 in the New England Journal of Medicine.
Oliver Sartor, M.D., from Tulane University in New Orleans, and colleagues conducted an international, phase 3 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 standard care alone. Patients were followed for a median of 20.9 months.
The researchers found that compared with standard care, 177Lu-PSMA-617 plus standard care significantly prolonged imaging-based progression-free survival (median, 8.7 versus 3.4 months; hazard ratio for progression or death, 0.40) and overall survival (median, 15.3 versus 11.3 months; hazard ratio for death, 0.62). 177Lu-PSMA-617 was significantly favored for all key secondary end points. A higher incidence of adverse events of grade 3 or above was seen with versus without 177Lu-PSMA-617 (52.7 versus 38.0 percent), while quality of life was not adversely affected.
“The trial aimed to assess the efficacy of 177Lu-PSMA-617 plus standard-care therapies that could safely be combined in order to provide physicians with a broad permitted range of concomitant treatment options,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Endocyte, which funded the study.