576MO Health-related quality of life (HRQoL), pain and safety outcomes in the phase III VISION study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer

[177Lu]Lu-PSMA-617 (177Lu-PSMA-617) delivers β-particle radiation to prostate-specific membrane antigen (PSMA) expressing cells and the surrounding microenvironment. In phase III VISION study (NCT03511664), 177Lu-PSMA-617 + protocol-permitted standard of care (SOC) prolonged radiographic progression-free survival (rPFS; HR, 0.40; 99.2% CI: 0.29, 0.57), overall (OS; 0.62; 95% 0.52, 0.74) time first symptomatic skeletal event (SSE; 0.50; 0.40, 0.62) versus SOC (all p < 0.001). was an international, open-label in adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) previously treated ≥ 1 androgen receptor pathway inhibitor 1–2 taxane regimens. Patients were randomized 2:1 (7.4 GBq every 6 weeks, ≤ cycles) plus or alone. rPFS OS alternate primary endpoints; SSE a key secondary endpoint. Other endpoints included safety patient-reported HRQoL (Functional Assessment Cancer Therapy – Prostate [FACT-P]) pain (Brief Pain Inventory Short Form [BPI-SF]). Pre-specified analyses occurrence HRQoL/pain worsening, disease progression death. Ad hoc worsening only (non-inferential). assessed pre-specified analysis set comprising 581 831 patients (177Lu-PSMA-617 arm, n = 385; control 196). time-to-worsening favoured arm (Table), despite higher incidence grade 3 adverse events No new unexpected concerns noted, including changes creatinine clearance.Table: 576MOHazard ratios for FACT-P BPI-SF scoresOutcome†Hazard ratio (95% confidence interval)FACT-P Total Pain-related subscale subscale0.46 (0.35, 0.61)* 0.55 (0.42, 0.71)* 0.59 (0.46, 0.76)*BPI-SF intensity Worst interference0.45 (0.33, 0.60)* 0.49 (0.37, 0.65)* 0.60 (0.45, 0.80)*† Time following from baseline. 10 point decrease total 2 pain-related 30% increase intensity, worst interference *p 0.001 (nominal; non-inferential analysis) Open table tab † generally well tolerated delayed alone advanced mCRPC.