The New England Journal of MedicineLutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer

Study Reveals Significant Extension in Progression-Free and Overall Survival Rates

In an international phase 3 trial, radioligand therapy using 177Lu-PSMA-617 demonstrated substantial benefits in treating advanced PSMA-positive metastatic castration-resistant prostate cancer. The therapy not only extended progression-free survival but also improved overall survival rates, offering a new avenue for treatment.

HCN Medical Memo
This study underscores the potential of 177Lu-PSMA-617 as a viable treatment option. Although adverse events were higher, the significant extension in both progression-free and overall survival rates cannot be overlooked. This therapy could be a game-changer in improving patient outcomes.

Study Design

• International, open-label, phase 3 trial
• Participants: 831 of 1179 screened patients with metastatic castration-resistant prostate cancer
• Treatment: 177Lu-PSMA-617 (7.4 GBq every 6 weeks for 4-6 cycles) plus standard care or standard care alone
• Primary Endpoints: Imaging-based progression-free survival and overall survival
• Secondary Endpoints: Objective response, disease control, and time to symptomatic skeletal events
• Adverse events monitored up to 30 days after the last dose

Metastatic castration-resistant prostate cancer remains fatal in most cases despite recent advances in treatment.

Key Findings

• Median imaging-based progression-free survival: 8.7 months with 177Lu-PSMA-617 vs. 3.4 months with standard care (P<0.001)
• Median overall survival: 15.3 months with 177Lu-PSMA-617 vs. 11.3 months with standard care (P<0.001)
• All key secondary endpoints significantly favored 177Lu-PSMA-617
• Incidence of grade 3 or above adverse events was higher in the 177Lu-PSMA-617 group (52.7% vs. 38.0%), but quality of life remained stable

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