Real-World PSA Response and Safety Outcomes of 177Lu-PSMA-617 in Heavily Pretreated Metastatic Castration-Resistant Prostate Cancer: A Single-Center Retrospective Validation Study

Background/Objectives: 177Lu-PSMA-617 is an established standard-of-care treatment for eligible patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Treatment schedules and follow-up in routine practice may differ from clinical trial protocols. Post-approval evaluation is needed to determine whether trial-reported prostate-specific antigen (PSA) responses and adverse events are also observed outside trials. We assessed outcomes in heavily pretreated patients receiving 177Lu-PSMA-617.

Methods

This retrospective study included 13 patients treated outside clinical trials at Severance Hospital, with follow-up through 30 June 2026. PSA50 and PSA90 denoted unconfirmed reductions of at least 50% and 90% from pretreatment baseline. Study-defined progression-free survival (PFS) included radiographic progression, a PSA increase of at least 50% from baseline considered disease progression, or death.