Pluvicto extends disease control in advanced hormone-sensitive prostate cancer

The Phase III PSMAddition trial presented at the 2025 European Society for Medical Oncology Congress marks a meaningful advance in the treatment of prostate cancer that still responds to hormonal therapy but has already spread to distant sites. In this study, patients with prostate-specific membrane antigen–positive metastatic hormone-sensitive prostate cancer received the radioligand therapy Pluvicto alongside standard hormonal therapy, or standard therapy alone. The addition of Pluvicto reduced the risk of radiographic disease progression or death by 28 percent, corresponding to a hazard ratio of 0.72. There was also an early, though not yet statistically mature, trend toward improved overall survival with a hazard ratio of 0.84 .​

Patients given Pluvicto showed greater tumor response, with complete responses in 57.1 percent compared to 42.3 percent on hormonal therapy alone, and an overall response rate of 85.3 versus 80.8 percent. The treatment delayed progression to the castration-resistant stage with a hazard ratio of 0.70 . Adverse effects were mostly low-grade and consistent with previous studies: dry mouth, fatigue, nausea, hot flushes, and anemia were among the most frequent. Severe (Grade ≥ 3) effects occurred in about 51 percent of patients receiving the radioligand combination compared with 43 percent on hormonal therapy alone .​

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