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Article History

Received: 5 March 2025

Revised: 26 October 2025

Accepted: 5 December 2025

First Online: 8 January 2026

Competing interests

: TB has received speakers’ honoraria from Astellas and travel fess from Ipsen and MSD. MR has received honoraria as a speaker/consultant by MSD, Merck Serono, Astrazeneca, Bristol Myers Squibb, Eisai and Gilead. LBV has received payments or honoraria from presentations, consulting or travel expenses from J&J, Bayer, Ipsen, Pfizer, MSD, BMS, Astellas, AstraZeneca, Tecnofarma, Merck. AJ reports payments or honoraria from presentations, speaker bureaus, consulting or travel expenses from J&J, Orion, Bayer, Astellas, Ipsen, Pfizer, BMS. JM-C declares consultant, advisory or speaker roles for IPSEN, Roche, Pfizer, Sanofi, Janssen, BMS, Exelisis, MSD, Adium, Astellas. JMC has received research grants from Pfizer, IPSEN, Janssen and Roche. TB has received institutional research support from AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Merck, and Novartis; consulting fees from Bristol Myers Squibb, Astellas, Janssen, and Sanofi/Aventis; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol Myers Squibb, Servier, and Pfizer; and institutional receipt of equipment, materials, drugs, medical writing, or other services from Bristol Myers Squibb, AstraZeneca, Roche, and Servier. JK has received payment or honoraria for consultations, lectures or educational events: Angelini, Astellas, Astra Zeneca, Bayer, Bristol Myers Squibb, IPSEN, Johnson&Johnson, Merck, MSD, Novartis, Pfizer, Research Funding: Novartis. MNGQ has received payments or honoraria from presentations, speaker bureaus, consulting, or travel expenses from Bayer, Astellas, Novartis, MSD, Merck Serono, Adium, Pfizer, Gador, and Elea. MTB has received payments or honoraria from presentations, speaker bureaus, consulting, or travel expenses from Bayer, Astellas, Novartis, MSD, Merck Serono, Adium, Pfizer, Johson & Johson, Asofarma Astra Zeneca. PR reports payments or honoraria for advisory board roles, presentations, speaker bureaus, manuscript writing, educational events, or travel support from AstraZeneca, Janssen, Pfizer, Merck, MSD Italy. OF received honoraria from Roche, Janssen, GSK, MSD, BMS, Pierre Fabre and Pfizer for consultations and lectures. Alejo Rodriguez-Vida reports serving in an advisory role for Pfizer, BMS, Merck, MSD, Astellas, Janssen, Bayer, Novartis and Ipsen; receiving honoraria or travel expenses from Pfizer, MSD, Astellas, Merck, BMS, Janssen, Astra Zeneca, Bayer, and Ipsen. YÜ has received honoraria or has served as consultant for Abdi-İbrahim, Astellas, Bristol Myers-Squibb, Deva, Eczacıbaşı, Gen İlaç, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, Roche. SS has received payments or honoraria from presentations, speaker bureaus, consulting or travel expenses from J&J, Bayer, Astellas, Novartis, Ipsen, MSD, BMS, Merck Serono. AP reports payments or honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events from BMS, Ipsen, Roche, Astellas, Merck, Eisai, MSD, Novartis, and Pfizer. DM has received honoraria for educational sessions from Astellas, Bayer and Janssen. AM has received payments or honoraria from presentations, consulting or travel expenses from Ipsen, MSD, Bayer, J&J, BMS. BM has received research funding, honoraria, and non-financial or other support from Roche, Pfizer, BMS, Astellas, Novartis, MSD, Merck Serono, AstraZeneca, Eisai, and E. Lilly. MW reports payments or honoraria from presentations, speaker bureaus, consulting or travel expenses from J&J, Bayer, Accord, Ipsen, AstraZeneca, Pfizer, MSD. PM reports payments or honoraria from presentations, speaker bureaus, consulting or travel expenses from J&J, Novartis, Orion, Bayer, Astellas, Ipsen, Amgen, AstraZeneca, Pfizer, MSD. FM has received research support and/or honoraria from Advanced Accelerator Applications, Astellas, Astra Zeneca, Bayer, BMS, Janssen, Ipsen, MSD and Pfizer. ESA has received grants and personal fees from Janssen, Sanofi, Bayer, Bristol Myers Squibb, Curium, MacroGenics, Merck, Pfizer, AstraZeneca, and Clovis; personal fees from Aadi Bioscience, Aikido Pharma, Astellas, Amgen, Blue Earth, Corcept Therapeutics, Exact Sciences, Hookipa Pharma, In-vitae, Eli Lilly, Foundation Medicine, Menarini-Silicon Biosystems, Tango Therapeutics, Tempus and Z-alpha; grants from Novartis, Celgene, and Orion; and has a patent for an AR-V7 biomarker technology that has been licensed to Qiagen. MS has received research support and honoraria from Janssen, Bristol Myers Squibb, Ipsen, MSD, Astellas and Bayer. The other authors declare to have no conflicts of interest.

: The protocol was approved on 18 April 2024 by the Ethics Committee of the coordinating centre (Marche Region - Italy - No. 2024 20, ‘ARON-3 Study’ protocol) and the Institutional Review Boards of each participating site. The study was conducted in accordance with the Declaration of Helsinki on human experimentation and Good Clinical Practice standards. Informed consent with subsequent analysis of the follow-up data was obtained from all participants.