A phase II study evaluating the efficacy of enzalutamide and the role of liquid biopsy for evaluation of ARv7 in mCRPC patients with measurable metastases including visceral disease (Excalibur study).

"Declarations Ethics approval and consent to participate: The study was approved by the local ethics committees of all participating institutions and was executed in accordance with Good Clinical Practice and the Declaration of Helsinki [ICH GCP E6(R2)]. All patients provided written informed consent before study procedures.Consent for publication: Not applicable.Author contributions:Pierangela Sepe: Data curation; Formal analysis; Methodology; Writing – original draft; Writing – review & editing.Giuseppe Procopio: Conceptualization; Project administration; Writing – review & editing.Chiara Carlotta Pircher: Writing – original draft.Umberto Basso: Data curation; Supervision; Validation; Writing – original draft.Orazio Caffo: Data curation; Validation.Vera Cappelletti: Data curation; Formal analysis; Investigation; Methodology; Writing – original draft.Melanie Claps: Validation; Writing – review & editing.Ugo De Giorgi: Data curation; Writing – original draft.Lucia Fratino: Data curation; Visualization.Valentina Guadalupi: Validation.Patrizia Miodini: Data curation; Formal analysis.Cinzia De Marco: Data curation; Formal analysis.Bruno Perrucci: Data curation; Visualization.Alessia Mennitto: Data curation; Validation; Visualization.Daniele Santini: Data curation; Visualization.Francesco Spina: Data curation; Validation.Marco Stellato: Data curation; Validation.Filippo de Braud: Validation.Elena Verzoni: Conceptualization; Data curation; Formal analysis; Funding acquisition; Supervision; Validation.Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by Astellas Pharma, the developers of enzalutamide. The funder contributed providing study drug and reviewing ad approving the manuscript. The authors had full access to the data and control of the final approval and decision to submit manuscript for publication.Competing interests: Dr Giuseppe Procopio reported receiving honoraria for consulting or advisory role AstraZeneca, Bayer, BMS, Ipsen, Janssen, MSD, Novartis, Pfizer, EISAI. Dr Elena Verzoni reported receiving honoraria for consulting or advisory role from Janssen, Ipsen, MSD, Merck, Pfizer, Novartis. No other disclosure were reported.Availability of data and materials: Data are available upon reasonable request. Competing interests: Dr Giuseppe Procopio reported receiving honoraria for consulting or advisory role AstraZeneca, Bayer, BMS, Ipsen, Janssen, MSD, Novartis, Pfizer, EISAI. Dr Elena Verzoni reported receiving honoraria for consulting or advisory role from Janssen, Ipsen, MSD, Merck, Pfizer, Novartis. No other disclosure were reported."

"Funding: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by Astellas Pharma, the developers of enzalutamide. The funder contributed providing study drug and reviewing ad approving the manuscript. The authors had full access to the data and control of the final approval and decision to submit manuscript for publication."

"Trial registration: ClinicalTrials.gov Identifier: NCT03103724. First Posted: 6 April 2017. First patient enrollment: 19 April 2017."