S1176
Clinical - Urology
ESTRO 2026
References: (1) Dearnaley D, Syndikus I, Mossop H, et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016;17(8):1047- 1060. doi:10.1016/S1470-2045(16)30102-4(2) Sritharan K, Daamen L, Pathmanathan A, et al. MRI-guided radiotherapy in twenty fractions for localised prostate cancer; results from the MOMENTUM study. Clin Transl Radiat Oncol. 2024;46:100742. Published 2024
University Hospital NHSFT, Norwich, United Kingdom. 18 Johnston Cancer Research Centre, Queen's University Belfast, Belfast, United Kingdom. 19 Patient and Public Representative, c/o ICR-CTSU, London, United Kingdom. 20 Ex-Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom Purpose/Objective: Intensity modulated radiotherapy (IMRT) to the prostate is a standard of care for early prostate cancer but it is unclear if extending radiotherapy to the pelvic nodes is beneficial. We present data on early and late side effects to 2 years, from the PIVOTALboost trial1 (ISRCTN80146950). Material/Methods: Men recruited from 38 UK centres with NCCN intermediate/high risk prostate cancer were randomised (1:1) to radiotherapy of 60Gy in 20 fractions (f) over 4 weeks to the prostate (P) with or without pelvic node radiotherapy (47Gy/20f; PPN). Side effects were assessed up to 18 weeks after starting radiotherapy (early effects), then 6-monthly for first 2 years (late effects) using CTCAE and RTOG scales. Follow-up continues for biochemical/clinical failure primary endpoint. Proportion of patients with grade 2 or higher (G2+) gastrointestinal (GI) and genitourinary (GU) side effects over 18 weeks and at 2 years were compared using chi-squared test. Kaplan-Meier estimates of cumulative late G2+ event rates to 2 years were compared with logrank test. Results: 1069 men were randomised (P: 535; PPN: 534); follow- up is complete to 2 years. 91% of participants had high risk prostate cancer. Median PSA at entry was 13.0ng/ml.Table 1 shows GI and GU worst CTCAE grade side effects over 18 weeks and to 2 years. G3+ side effects were rare.
Feb 7. doi:10.1016/j.ctro.2024.100742 Keywords: MR-guided radiotherapy
Proffered Paper 1233 Side effects of moderately hypofractionated prostate and pelvic lymph node IMRT; results from the phase 3 PIVOTALboost randomised trial Isabel Syndikus 1 , Elizabeth Limb 2 , John Staffurth 3 , Alison Tree 4 , Ann Henry 5 , Olivia Naismith 6 , Helen Mayles 7 , Anjali Zarkar 8 , Anna Lydon 9 , Joanna Bowen 10 , John Frew 11 , John McGrane 12 , Miguel Panades 13 , Nick Everritt 2 , Peter Bownes 14 , Peter Hoskin 15 , Ramachandran Venkitaraman 16 , Robert Wade 17 , Stephanie Brown 2 , Suneil Jain 18 , Susan Campbell 19 , Swechha Sirohi 2 , Vicki Hinder 20 , Clare Cruickshank 2 , Emma Hall 2 1 Department of Oncology, The Clatterbridge Cancer Centre, Wirral, United Kingdom. 2 Clinical Trial and Statistics Unit, Institute of Cancer Research, London, United Kingdom. 3 Department of Oncology, Velindre Cancer Centre, Cardiff, United Kingdom. 4 Department of Oncology, The Royal Marsden NHS Trust, London, United Kingdom. 5 Department of Oncology, Leeds Cancer Centre, Leeds, United Kingdom. 6 National RTQA, Radiotherapy Trials Quality Assurance (RTTQA) Group, London, United Kingdom. 7 National RTQA, Radiotherapy Trials Quality Assurance (RTTQA) Group, Wirral, United Kingdom. 8 Department of Oncology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom. 9 Department of Oncology, Torbay & South Devon NHSFT, Torquay, United Kingdom. 10 Department of Oncology, Cheltenham General Hospital, Cheltenham, United Kingdom. 11 Department of Oncology, Freeman Hospital, Newcastle, United Kingdom. 12 Department of Oncology, Royal Cornwall Hospital, Truro, United Kingdom. 13 Clinical Oncology, United Lincolnshire Teaching Hospitals Trust, Lincoln, United Kingdom. 14 Medical Physics and Engineering, St James’s University Hospital, Leeds, United Kingdom. 15 Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, United Kingdom. 16 Department of Oncology, Ipswich Hospital, Ipswich, United Kingdom. 17 Department of Oncology, Norfolk & Norwich
Early GI CTCAE G2+ side effects were twice as common with PPN (P 15.5%, PPN 30.4%; p<0.0001). Most
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