FDA’s decision to move lutetium Lu 177 vipivotide tetraxetan into earlier metastatic hormone-sensitive prostate cancer settings is already triggering label-aligned diagnostic work around PSMA PET selection. The approval requires PSMA expression determination using gallium Ga 68 gozetotide (Locametz) or another compatible PSMA PET product. The regulatory change matters for workflow design in urology and oncology clinics, because PSMA imaging now becomes a gatekeeper for expanding radioligand therapy use in mHSPC. For care teams, the label effectively couples imaging capacity to treatment eligibility, influencing staging timelines and access to the radioligand regimen. Clinically, the FDA action builds on PSMAddition’s risk reduction in progression or death and ongoing OS maturation, positioning radioligand intensification earlier in the disease course. The next phase of evidence will depend on the final OS analysis and continued follow-up.