Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)
NCT Number: NCT06496581
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Prostate Cancer Metastatic
Interventions: DRUG: 177Lu-PMSA-617|DRUG: Standard of Care
Sponsor: UNICANCER
Collaborators: Novartis
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2039-08-01
Locations: Institut de Cancérologie de l'Ouest, Angers, France|Institut Bergonié, Bordeaux, France|CHRU Brest, Brest, France|Centre Francois Baclesse, Caen, France|CHU Henri Mondor, Créteil, France|Centre Georges-François Leclerc, Dijon, France|CHU Grenoble, Grenoble, France|Centre Léon Berard, Lyon, France|Institut Paoli-Calmettes, Marseille, France|CHRU Nancy, Nancy, France|Centre Antoine Lacassagne, Nice, France|Hôpital Cochin, Paris, France|Hôpital Saint Louis, Paris, France|Institut Curie, Paris, France|Centre Eugène Marquis, Rennes, France|Centre Henri Becquerel, Rouen, France|CHU Rouen, Rouen, France|Institut Curie, Saint-Cloud, France|Institut de Cancérologie de l'Ouest, Saint-Herblain, France|CHU Saint Etienne, Saint-Priest-en-Jarez, France|ICANS, Strasbourg, France|IUCT Oncopole, Toulouse, France|CHRU Tours, Tours, France|Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France|Gustave Roussy, Villejuif, France

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).

Primary Outcome Measures: 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., From randomization to death due to any cause, up to 8.5 years|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., From randomization to radiographic progression or death, up to 8.5 years
Secondary Outcome Measures: 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., From randomization to onset of castration-resistance or death, up to 8.5 years|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., From the date of randomization to a PCSS event, up to 8.5 years|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., From baseline over the treatment period, up to 8.5 years|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., From randomization to the onset of a SRE-FS event, up to 8.5 years|Time to severe urinary event (SUE), Time to severe urinary event (SUE) is defined as the time from the randomization date to the date of diagnosis of either one of the following SUE, whichever occurs first: urinary retention with need for a urinary catheter, suprapubic catheter, double J stent, nephrostomy, treatment of the prostate by radiotherapy or trans-urethral resection of the prostate (TURP) or prostatectomy done to relieve patients with local symptoms., From randomization to the onset of a SUE event, up to 8.5 years|Time to initiation of first subsequent anti-cancer systemic therapy for CRPC (TTSST1), TTSST1 is defined as the time from the randomization date to the date of initiation of the first anti-cancer systemic therapy for CRPC., From randomization to initiation of the first anti-cancer systemic therapy for CRPC, up to 10 years|Time to initiation of second subsequent anti-cancer systemic therapy for CRPC (TTSST2), TTSST2 is defined as the time from the randomization date to the date of initiation of the second anti-cancer systemic therapy for CRPC., From randomization to initiation of the second anti-cancer systemic therapy for CRPC, up to 10 years|Efficacy of first subsequent anti-cancer systemic therapy for CRPC, Efficacy of subsequent anti-cancer systemic therapy for CRPC will be defined as the time from first anti-cancer systemic therapy for CRPC to disease progression or death from any cause, whichever comes first., From first anti-cancer systemic therapy for CRPC to disease progression or death, up to 10 years|Efficacy of second subsequent anti-cancer systemic therapy for CRPC, Efficacy of second subsequent anti-cancer systemic therapy for CRPC will be defined as the time from second anti-cancer systemic therapy for CRPC to disease progression or death from any cause, whichever comes first., Fromsecond anti-cancer systemic therapy for CRPC to disease progression or death, up to 10 years