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).
Signed a written informed consent form prior to any trial specific procedures.
Aged ≥18 years old
Life expectancy > 6 months as per investigator estimate
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Any evidence of cancer progression (including a rising PSA level, clinical progression, or radiological progression)
Prior or concurrent PSMA-based radioligand therapy or other PSMA target treatments
Known hypersensitivity to the components of the study therapy or its analogs
Any condition preventing the use of the standard of care and/or specific experimental treatments tested in the trial
UNICANCER
Lead sponsor
Novartis
Collaborator