Phase 3 Study of Lutetium (177Lu) Vipivotide Tetraxetan in OMPC Patients

Status: RECRUITING | Phase: PHASE3 Condition(s): Oligometastatic Prostate Cancer (OMPC) Intervention(s): AAA617 (DRUG) The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT). Detailed: All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium (68Ga) gozetotide (also known as \[68Ga\]Ga-PSMA-11) or piflufolastat (18F) ( also known as\[18F\]DCFPyL) PET/CT scan and CI (i.e., CT/MRI and bone scans). Piflufolastat (18F) PET/CT scan will be performed in countries where it is approved. Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic Prostate Cancer (PC) lesions after randomization and before the start of treatment with AAA617 or observation. * The duration of SBRT procedures is approximately 3 weeks. * For participants randomized to the investigational arm (AAA617), the treatment duration will be up to 4 cycles of AAA617. For participants randomized to the control arm (obser Primary Outcome(s): Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS) Enrollment: 450 (ESTIMATED) Lead Sponsor: Novartis Pharmaceuticals Start: 2024-03-12 | Primary Completion: 2028-04-25