Outcome of patients with PSMA-PET/CT screen failure by VISION criteria and treated with ¹⁷⁷Lu-PSMA therapy: a multicenter retrospective analysis

Abstract

The aim of the study was to assess the outcome of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with ¹⁷⁷Lu-PSMA who would have been screen failures (SF) in the VISION trial based on PSMA PET/CT criteria. Methods: We conducted a retrospective multicenter cohort study in 301 mCRPC patients treated with ¹⁷⁷Lu-PSMA. The patients were classified into eligible (VISION-PET-E) and SF (VISION-PET-SF) groups based on the baseline PSMA-PET/CT. PSA response rates (decline of ≥50% (PSA50RR)), PSA-progression-free survival (PSA-PFS), and overall survival (OS) were compared. Results: 272/301 (90.4%) and 29/301 (9.6%) men were VISION-PET-E and VISION-PET-SF, respectively. The VISION-PET-SF patients had worse PSA50RR (21% vs. 50%; P = 0.005) and PSA-PFS (2.1 vs. 4.1 months; P = 0.023), and tended to have a shorter OS (9.6 vs. 14.2 months; P = 0.16) than the VISION-PET-E patients. Conclusion: The VISION-PET-SF patients had worse outcomes than the VISION-PET-E patients. Our cohort did not include pre-excluded patients (10-15%) by local sites assessments. Thus, 20-25% of the patients may be screen failures in unselected populations. Refinements in patient selection for ¹⁷⁷Lu-PSMA are needed to optimize outcomes.