Top Line: Should Pluvicto be added to ADT and an androgen receptor pathway inhibitor for metastatic, castration sensitive prostate cancer?
The Study: Pluvicto is currently indicated for PSMA+, mCRPC that progresses on ADT/ARPI. In PSMAddition, 1144 patients with treatment naive mCSPC and at least one PSMA+ lesion were randomized to receive ADT plus ARPI with or without 6 cycles of Pluvicto. Half of patients had de novo metastatic disease, and 68% had high volume metastatic disease. The addition of Pluvicto significantly improved the primary endpoint of radiographic progression free survival with a 28% relative reduction (HR 0.72; 95% CI 0.58–0.90; p=0.0021). Median rPFS was not yet reached in either arm, and the rate of events was 24% with Pluvicto and 30% without. Grade 3+ adverse events were higher with Pluvicto (51% v 43%), but serious adverse events were similar.
TBL: As of late July, Pluvicto is now FDA approved along with ADT + ARPI for patients with PSMA+ mCSPC. | Tagawa, Lancet 2026
The Study: Pluvicto is currently indicated for PSMA+, mCRPC that progresses on ADT/ARPI. In PSMAddition, 1144 patients with treatment naive mCSPC and at least one PSMA+ lesion were randomized to receive ADT plus ARPI with or without 6 cycles of Pluvicto. Half of patients had de novo metastatic disease, and 68% had high volume metastatic disease. The addition of Pluvicto significantly improved the primary endpoint of radiographic progression free survival with a 28% relative reduction (HR 0.72; 95% CI 0.58–0.90; p=0.0021). Median rPFS was not yet reached in either arm, and the rate of events was 24% with Pluvicto and 30% without. Grade 3+ adverse events were higher with Pluvicto (51% v 43%), but serious adverse events were similar.
TBL: As of late July, Pluvicto is now FDA approved along with ADT + ARPI for patients with PSMA+ mCSPC. | Tagawa, Lancet 2026