FDA approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), extending radioligand therapy earlier in the disease course. The decision is based on the phase 3 PSMAddition trial (NCT04720157), where the regimen reduced the risk of progression or death versus standard-of-care therapy alone. In PSMAddition, the combination delivered a 28% reduction in progression or death (HR 0.72; 95% CI 0.58–0.90), with an updated analysis showing an additional risk reduction (HR 0.67; 95% CI 0.55–0.82). Investigators also reported a positive trend toward improved overall survival, though final OS data are still maturing. Eligibility requires confirming PSMA expression using gallium Ga 68 gozetotide (Locametz) or another PET product. Memorial Sloan Kettering’s Michael Morris, MD, said in the trial release that earlier intensification “meaningfully expands the options” for clinicians at this stage.