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
Parallel
177Lu-PMSA-617
DrugOnce every 6 weeks, 7400 MBq 177Lu-PMSA-617 will be administered for up to a total of 4 cycles.
Standard of Care
DrugADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care
Overall survival (OS)
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.
Radiographic progression-free survival (rPFS)
Radiographic progression-free survival (rPFS) is defined as the time from randomization to the date of radiographic progression according to PCWG3 criteria by investigator assessment, or death, whichever occurs first.
Castration-Resistance Prostate Cancer-Free Survival (CRPC-FS)
Castration-Resistance Prostate Cancer-Free Survival (CRPC-FS) is defined as the time from randomization to the onset of castration-resistance or death from any cause, whichever occurs first.
Prostate Cancer-Specific Survival (PCSS)
Prostate Cancer-Specific Survival (PCSS) is defined as the time from the date of randomization to the date of death due to prostate cancer.
PSA response
PSA response will be assessed by the maximum change of PSA (rise or fall) from baseline over the treatment period. A complete PSA response is defined by an undetectable level of serum PSA.
Skeletal-related event-free survival (SRE-FS)
Skeletal-related event-free survival (SRE-FS) is defined as the time from the randomization date to the date of diagnosis of either a skeletal-related event (SRE) (fracture, or bone pain requiring radiation therapy, or spinal cord compression, or preventive surgery to the bones) or death, whichever occurs first.
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UNICANCER
Lead sponsor
Novartis
Collaborator
