%0 Journal Article
%A Fizazi, K.
%A Chi, K. N.
%A Shore, N. D.
%A Herrmann, Volker
%A de Bono, J. S.
%A Castellano, D.
%A Piulats, J. M.
%A Fléchon, A.
%A Wei, X. X.
%A Mahammedi, H.
%A Roubaud, G.
%A Fleming, M.
%A Haas, T.
%A Ghebremariam, S.
%A Kreisl, T. N.
%A Rajagopalan, S.
%A Sartor, O.
%A Morris, M. J.
%T Final overall survival and safety analyses of the phase 3 PSMAfore trial of [177Lu]Lu-PSMA-617 versus change of androgen receptor pathway inhibitor in taxane-naive patients with metastatic castration-resistant prostate cancer.
%J Annals of oncology
%V nn
%@ 0923-7534
%C Amsterdam [u.a.]
%I Elsevier
%M DKFZ-2025-01452
%P nn
%D 2025
%Z epub
%X In PSMAfore, [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolonged radiographic progression-free survival (rPFS) in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC), with a favourable safety profile, versus a change in androgen receptor pathway inhibitor (ARPI). We report the final overall survival (OS) analysis and updated safety data.PSMAfore (NCT04689828) was an open-label, international, phase 3 trial. Patients with prostate-specific membrane antigen (PSMA)-positive mCRPC who had experienced disease progression once on a previous ARPI and were candidates for ARPI change were randomized 1:1 to 177Lu-PSMA-617 or ARPI change to abiraterone or enzalutamide. Crossover from ARPI change to 177Lu-PSMA-617 was allowed after centrally confirmed radiographic progression. Endpoints included rPFS (primary), OS (key secondary), and safety (secondary).Patients were randomized to 177Lu-PSMA-617 or ARPI change (n = 234 each): 141/234 participants (60.3
%K (177)Lu-PSMA-617 (Other)
%K Metastatic castration-resistant prostate cancer (Other)
%K overall survival (Other)
%K radioligand therapy (Other)
%K safety (Other)
%K taxane-naive (Other)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:40680993
%R 10.1016/j.annonc.2025.07.003
%U https://inrepo02.dkfz.de/record/303005