PSMAddition

PSMAddition, trial NCT04720157 sponsored by Novartis and reported in 2025, moved Pluvicto, or 177Lu-PSMA-617, into the first-line treatment of metastatic prostate cancer, and the FDA approved this use on 31 July 2026. It randomised 1,144 men with PSMA-positive metastatic hormone-sensitive disease to the radioligand plus androgen deprivation and an androgen receptor pathway inhibitor or to standard care alone, and met its primary radiographic progression-free survival endpoint at the second interim analysis, data cut-off 13 January 2025, with a hazard ratio of 0.72 and the median not reached in either arm, while overall survival was not reported and severe adverse events were more common. OnCo links it to radioligand therapy, the CRPC term and the idea of alpha-emitting PSMA therapy at first diagnosis. Whether early radioligand use improves survival or only delays progression is the open question.