FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) plus an androgen receptor pathway inhibitor (ARPI) for adult patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The decision expands radioligand therapy from later-stage metastatic settings into the hormone-sensitive stage. The approval is based on the phase 3 PSMAddition trial (NCT04720157). In the randomized study, the combination reduced risk of progression or death versus standard-of-care (ARPI plus androgen deprivation therapy, ADT), with an HR of 0.72 (95% CI 0.58–0.90). An updated analysis reported HR 0.67 (95% CI 0.55–0.82) and a positive—though not definitive—trend toward overall survival (HR 0.80; 95% CI 0.63–1.01), with final OS still pending. Treatment requires PSMA tumor selection using gallium Ga 68 gozetotide (Locametz) or another PET product that determines PSMA expression, per FDA labeling. Memorial Sloan Kettering’s Michael Morris, MD, highlighted that earlier intensification expands physician options for this mHSPC population.