Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: All of the following criteria must be met ahead of randomization to satisfy trial eligibility requirements: 1. Signed a written informed consent form prior to any trial specific procedures. Note: In case of physical incapacitation, a trusted representative of their choice, which is not the Investigator or sponsor, can sign on the behalf of the patients. 2. Aged ≥18 years old 3. Life expectancy \> 6 months as per investigator estimate 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 5. Men with histologically or cytologically confirmed adenocarcinoma of the prostate 6. De novo metastatic disease defined by clinical or radiographic evidence of metastases at diagnosis (i.e. before any treatment started). If not available, a more recent imaging can be used 7. Measurable disease or bone lesions evaluable according to PCWG3 criteria. Patients with doubtful bone metastases are not eligible 8. A pre-randomization 68Ga-PSMA-11 PET/CT scan performed within