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

PEACE-6 Poor Responders is an international, multicenter, open-label, controlled, randomized, phase III trial to evaluate the efficacy and safety of 177Lu-PSMA-617 when administered on top of the ongoing standard systemic treatment compared to standard systemic treatment alone in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) who do not present with a satisfactory response characterized by a serum prostatic specific antigen (PSA) level of ≥ 0.2 ng/mL at 6 to 8 months after systemic treatment initiation for mHSPC (i.e. poor responders) in the absence of evidence of cancer progression (including a rising PSA level).

NCT Number	NCT06496581
Lead Sponsor	UNICANCER Collaborators: Novartis
Conditions	Prostate Cancer Metastatic
Enrollment	500 participants
Start Date	2024-09-12
Primary Completion	2033-02-01 (estimated)
Study Completion	2039-08-01 (estimated)
Updated on ClinicalTrials.gov	2024-12-20