Enzalutamide in metastatic hormone-sensitive prostate cancer: results from the international, multicentre, real-world ARON-3 study
(2026) Prostate Cancer and Prostatic Diseases — (2026)
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- Authors
Büttner, Thomas 
Rizzo, Mimma
- Abstract
- BACKGROUND: Enzalutamide (ENZA), a next-generation non-steroidal androgen receptor (AR) inhibitor, plays a pivotal role in the management of both hormone-sensitive (HSPC) and androgen deprivation-resistant prostate cancer (ARPC). This paper presents real-world clinical outcomes of ENZA in a subgroup of metastatic HSPC (mHSPC) patients included in the ARON-3 study. METHODS: Clinical information was extracted retrospectively from medical records at 29 cancer centres in 9 countries worldwide. Overall Survival (OS) was calculated from starting ENZA to death from any cause and the time on treatment (ToT) from ENZA initiation to discontinuation for any reason. The Kaplan-Meier method was used to estimate OS and ToT. PSA90 was defined as a ≥90% PSA reduction from baseline, and PSA0.2 as the achievement of an ultra-low PSA level ≤0.2 ng/ml. Adverse events (AEs) were categorised according to Common Terminology Criteria for Adverse Events v5.0. RESULTS: The study population comprised 424 patients treated with ENZA for mHSPC, of whom 80 (19%) had lymph node-only metastases, 265 (63%) bone-only metastases, and 50 (12%) visceral metastases. 273 patients (64%) had synchronous metastases and 151 (36%) had developed metachronous metastases. A total of 228 patients were diagnosed with low-volume disease, and 196 patients (46%) with high-volume disease. The median ToT was 31.8 months, and the median OS was not reached. The median time to PSA90 (achieved in 76% of patients) and PSA0.2 (59% of patients) was 6.0 months and 8.3 months, respectively. Statistically significant associations were identified between lymph node-only patterns, PSA90 and ultra-low PSA responses, and longer treatment duration and better overall survival. Grade 3-4 AEs were observed in 9% of patients <70 years and in 10% ≥70 years. CONCLUSIONS: Real-world clinical practice corroborates the findings from clinical trials, confirming the effectiveness and safety of ENZA in mHSPC patients. Prostate Cancer and Prostatic Diseases; https://doi.
- Affiliations
University Hospital Bonn, Bonn, Germany Department of Urology and Paediatric Urology Azienda Ospedaliera Universitaria Consorziale - Policlinico di Bari, Bari, Italy Division of Medical Oncology Clínica Universitaria Colombia– Clínica de Marly, Bogotá, Colombia Servicio de Oncología Hospital Universitario Ramón y Cajal, Madrid, Spain Medical Oncology Department Jerez University Hospital, Jerez, Spain Department of Urology Charles University and University Hospital Motol, Prague, Czech Republic Department of Oncology, Second Faculty of Medicine Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland Department of Uro-Oncology Instituto de Oncologia Ángel H. Roffo, Buenos Aires, Argentina Division of Genitourinary Medical Oncology Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico Hematology and Oncology Department University Hospital Münster, Münster, Germany Department of Urology West German Cancer Center, Münster, Germany West German Cancer Center, Münster, Germany University Hospital Hradec Kralove, Hradec Kralove, Czech Republic Department of Clinical Oncology and Radiotherapy Newcastle University, Newcastle upon Tyne, UK Translational and Clinical Research Institute, Centre for Cancer University Hospital in Pilsen, Charles University, Pilsen, Czech Republic Department of Oncology and Radiotherapeutics, Faculty of Medicine Charles University, Pilsen, Czech Republic Biomedical Center, Faculty of Medicine in Pilsen Hospital del Mar, Barcelona, Spain Medical Oncology Department University of Kentucky, Lexington, KY, USA Division of Medical Oncology, Markey Cancer Center Ankara University Medical Faculty, Ankara, Türkiye Medical Oncology AORN“A. Cardarelli” , Naples, Italy Department of Medical Oncology Brno, Czech Republic Masaryk Memorial Cancer Institute Masaryk University, Brno, Czech Republic Faculty of Medicine Velindre Road, Whitchurch, Cardiff, Wales Velindre Cancer Centre University of Kansas Cancer Center, Westwood, KS, USA Division of Medical Oncology, Department of Internal Medicine TDM, IRCCS Istituto Tumori“Giovanni Paolo II”, Bari, Italy S.S.D. C.O.r.O. Bed Management Presa in Carico Candiolo Cancer Institute, IRCCS-FPO, Torino, Italy Oncology Department Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy Medical Oncology Unit Palacký University, Olomouc, Czech Republic Department of Oncology, Faculty of Medicine and Dentistry Goethe University Frankfurt, University Hospital, Frankfurt am Main, Germany Department of Urology University Hospital Hamburg-Eppendorf, Hamburg, Germany Martini-Klinik Prostate Cancer Center IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy Medical Oncology University of Bologna, Bologna, Italy Department of Medical and Surgical Sciences (DIMEC) University of Minnesota, Minneapolis, MN, USA Masonic Cancer Center Macerata Hospital, Macerata, Italy Medical Oncology Unit
Citations
Büttner, T., Rizzo, M., Bernal Vaca, L., Molina-Cerrillo, J., Alonso-Gordoa, T., Juárez, A., Buchler, T., Seront, E., Kucharz, J., Gandur Quiroga, M., Bourlon, M., Bögemann, M., Kopecky, J., Rescigno, P., Fiala, O., Rodriguez-Vida, A., Myint, Z., Ürün, Y., Scagliarini, S., & Poprach, A. (2026). Enzalutamide in metastatic hormone-sensitive prostate cancer: results from the international, multicentre, real-world ARON-3 study. Prostate Cancer and Prostatic Diseases. Published. https://doi.org/10.1038/s41391-025-01067-3 (Original work published 2026)