TY  - JOUR
AU  - Fizazi, K.
AU  - Chi, K. N.
AU  - Shore, N. D.
AU  - Herrmann, Volker
AU  - de Bono, J. S.
AU  - Castellano, D.
AU  - Piulats, J. M.
AU  - Fléchon, A.
AU  - Wei, X. X.
AU  - Mahammedi, H.
AU  - Roubaud, G.
AU  - Fleming, M.
AU  - Haas, T.
AU  - Ghebremariam, S.
AU  - Kreisl, T. N.
AU  - Rajagopalan, S.
AU  - Sartor, O.
AU  - Morris, M. J.
TI  - 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.
JO  - Annals of oncology
VL  - nn
SN  - 0923-7534
CY  - Amsterdam [u.a.]
PB  - Elsevier
M1  - DKFZ-2025-01452
SP  - nn
PY  - 2025
N1  - epub
AB  - 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
KW  - (177)Lu-PSMA-617 (Other)
KW  - Metastatic castration-resistant prostate cancer (Other)
KW  - overall survival (Other)
KW  - radioligand therapy (Other)
KW  - safety (Other)
KW  - taxane-naive (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:40680993
DO  - DOI:10.1016/j.annonc.2025.07.003
UR  - https://inrepo02.dkfz.de/record/303005
ER  -