Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
A Randomized Phase III Trial Evaluating the Efficacy and Safety of Standard of Care +/- 177Lu-PSMA617 in de Novo Metastatic Hormone-sensitive Prostate Cancer Patients Having a PSA≥0.2 ng/mL at 6-8 Months After Systemic Treatment Initiation
UNICANCER
500 participants
Sep 12, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Plain Language Summary
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Interventions
Once every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles.
ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care
Locations(25)
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NCT06496581