#ESMO26 TiP

PEACE-6 Poor Responders: Ph 3 trial of early 177Lu-PSMA-617 intensification in de novo mHSPC with poor PSA response to initial SOC (planned n=500)

💭 PSA ≥0.2 ng/mL at 6–8 mos despite SOC identifies a poor-prognosis group → rationale for response-adapted LuPSMA intensification

🔹 Randomized 1:1 • SOC vs SOC + 177Lu-PSMA-617 7.4 GBq q6w ×4
🔹 Key eligibility: de novo mHSPC • PSA ≥0.2 ng/mL at 6–8 mos • no progression • castrate testosterone
🔹 PSMA-PET required, but PSMA-negative pts remain eligible
🔹 Coprimary endpoints: rPFS & OS
🔹 Powered for HR 0.66 for rPFS & HR 0.73 for OS
🔹 79 pts randomized across 19 centers to date

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