Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
Status:
RECRUITING
Trial end date:
2039-08-01
Target enrollment:
Participant gender:
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).
Phase:
PHASE3
Details
Lead Sponsor:
UNICANCER
Collaborator:
Novartis
Treatments:
Androgen Antagonists apalutamide darolutamide Docetaxel enzalutamide Pluvicto Prednisone Radiotherapy Standard of Care