Prospectively collected long-term adverse event data with pre-radiotherapy assessment and regular follow-up reflecting 'real world settings' are still limited. Here, we present the available data on early and long-term outcomes up to eight years after radiotherapy in men with prostate cancer who participated in the international REQUITE cohort study, stratified by treatment modalities and patient characteristics.
Longitudinal data on pre-radiotherapy, acute and late symptoms up to eight years after radiotherapy were available from 1760 non-metastatic prostate cancer patients recruited in seven European countries and the USA. External beam radiotherapy (EBRT) and/or brachytherapy were given with curative intent between 2014 and 2016 according to local regimens. Gastrointestinal (GI) and genitourinary (GU) symptoms including sexual dysfunction were prospectively assessed by healthcare professionals according to CTCAE v4.0. Patient-reported outcomes were collected.
The highest incidence of clinician-reported grade ≥ 2 long-term GI and GU symptoms were for proctitis (12.1%) and haematuria (12.9%) among the EBRT-only treated patients, and proctitis (6.4%) and urinary incontinence (32.4%) among the post-prostatectomy/EBRT patients. Incidence of grade 3 adverse events was below 1.5%, with the only exception of late urinary incontinence in post-prostatectomy patients (10.2%).
The frequency and distribution of GI and GU symptoms in a real-world multicentre cohort of patients following prostate radiotherapy were comparable to those reported in large interventional trials. Our finding highlights the value of standardised data farming approaches like the REQUITE project. Most patients consented to provide their data for future cancer research which is available on request.
Clinical and translational radiation oncology. 2026 Jul 02*** epublish ***
Philipp Heumann, Juan Camilo Rosas Romero, Miguel E Aguado Barrera, Ester Aguado Flor, Barbara Avuzzi, David Azria, Erik Briers, Ana Carballo-Castro, Jenny Chang-Claude, Ananya Choudhury, Alison Dunning, Rebecca M Elliott, Laura Fachal, Marie-Pierre Farcy-Jacquet, Antonio Gómez-Caamaño, Sara Gutiérrez-Enríquez, Carsten Herskind, Rudolf Kaaks, Sarah L Kerns, Maarten Lambrecht, Xavier Maldonado, Morgan Michalet, Barbara Noris Chiorda, Paula Peleteiro-Higueiro, Tim Rattay, Barry S Rosenstein, Dirk De Ruysscher, Elena Sperk, Hilary Stobart, R Paul Symonds, Christopher J Talbot, María Aránzazu Tubío-Abuín, Ana Vega, Liv Veldeman, Marlon R Veldwijk, Tim Ward, Adam Webb, Catharine M L West, REQUITE/REQUITEplus/RADprecise consortia , Petra Seibold, Tiziana Rancati
Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany., Grupo Genética en Cáncer y Enfermedades Raras, Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain., Hereditary Cancer Genetics Group, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain., Unit of Radiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy., Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, ICM, Univ Montpellier INSERM U1194 IRCM, Montpellier, France., Patient Advocate., University of Manchester, Christie Hospital NHS Foundation Trust, United Kingdom., University of Cambridge, United Kingdom., The Christie NHS Foundation Trust, United Kingdom., Wellcome Sanger Institute, United Kingdom., Federation Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut du Cancer Du Gard (ICG), CHU Carémeau, Nîmes, France., Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Medical College of Wisconsin, USA., UZ, Leuven, Belgium., Department of Radiation Oncology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain., University of Leicester, United Kingdom., Departments of Radiation Oncology & Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, USA., MAASTRO Clinic, Maastricht, Netherlands., Mannheim Cancer Center, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany., Ghent University Hospital, Belgium., Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.