August 6, 2026 · Lancet (London, England) · DOI: 10.1016/S0140-6736(26)01092-5

[<sup>177</sup>Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial

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The PSMAddition trial aimed to evaluate the efficacy and safety of combining [^177Lu]Lu-PSMA-617 with androgen deprivation therapy (ADT) and androgen receptor pathway inhibitors (ARPI) in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer. The results indicated that this combination significantly improved radiographic progression-free survival compared to the control group, despite a higher incidence of adverse events, suggesting it may be a viable new treatment option for this patient population.

Scott T Tagawa, Oliver Sartor, Josep M Piulats, Fred Saad, Karim Fizazi, Alison Reid, Himisha Beltran, Gero Kramer, Hakim Mahammedi, Matthias Eiber, Shilpa Gupta, Daniel Castellano, Ralph Hauke, Hyun Kim, Cheol Kwak, See Tong Pang, Philippe Barthélémy, Dong Dai, Jae Lyun Lee, Luke Nordquist, Russell Z Szmulewitz, Paweł Wiechno, Alejandro Yovine, Lauren Smith, Emmanuel Bouillaud, Olga Sakharova, Michael J Morris, PSMAddition Investigators

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