Randomized Trial of Standard Treatment With or Without 177Lu-PSMA-617 in Men With Newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer and Poor PSA Response After 6 to 8 Months of Therapy

What this Trial Is About

Researchers are investigating the effectiveness and safety of adding 177Lu-PSMA-617 to the standard treatment for men with newly diagnosed metastatic hormone-sensitive prostate cancer who have a poor prostate-specific antigen (PSA) response after 6 to 8 months of systemic therapy. This phase III, open-label, controlled trial focuses on patients whose PSA levels remain at or above 0.2 ng/mL without signs of cancer progression. The trial aims to provide data on overall survival and progression-free survival up to 8.5 years after randomization. The study will enroll 500 patients who will be randomly assigned to receive either standard care alone, which includes androgen deprivation therapy (ADT) with androgen receptor signaling inhibitors (ARSI) and optional radiotherapy, or standard care combined with 177Lu-PSMA-617. The investigational drug is given every 6 weeks for up to four cycles. Treatment will continue until patients develop castration-resistant prostate cancer or based on clinical decisions, with the possibility of stopping due to side effects or patient choice. After treatment ends, participants will be followed for up to 102 months to monitor long-term outcomes. Participants will undergo a series of assessments including imaging with 68Ga-PSMA-11 PET/CT scans before randomization and regular monitoring of PSA levels, blood tests to check organ function, and performance status evaluations. Researchers will track overall survival and radiographic progression-free survival as primary outcomes. Safety and tolerability will also be closely observed throughout the study, which is expected to last about 18.5 years in total.

Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)