S2966
Late-Breaking
ESTRO 2026
androgen receptor pathway inhibitor that preserves testosterone, added to SBRT improves metastasis-free survival compared with SBRT alone. Material/Methods: In this multicentre, open-label, randomised, phase 2 trial conducted at 7 centers in Belgium, patients with PSMA PET-detected oligorecurrent hormone-sensitive prostate cancer ( ≤ 5 metastases, PSA doubling time ≤ 12 months) were randomly assigned (1:1) to SBRT plus 24 weeks of darolutamide 600 mg twice daily (SBRT+DARO) or SBRT alone (SBRT). The primary endpoint was metastasis-free survival (MFS) in the intention-to-treat population. This trial is registered on ClinicalTrials.gov, NCT04641078. Results: Between February 2021 and August 2023, 124 patients were randomly assigned (63 to SBRT + DARO, 61 to SBRT). For clinical progression-free survival the point estimate favored SBRT + DARO (HR 0·71 [0·46–1·08]; p=0·11). Although not allowed, 13% of patients received ADT in the SBRT arm versus 8% in the SBRT+DARO arm at time of non-metastatic clinical or biochemical progression. Median MFS was 18 months (95% CI 16–25) for SBRT+DARO versus 15 months (12– 24) for SBRT (stratified HR 0·84 [95% CI 0·55–1·30]; p=0·4). Two grade >2 adverse events were possibly or probably related to SBRT (urinary incontinence and lumbar pain) and none were related to Darolutamide. The following grade 1-2 adverse events were more prevalent in SBRT + DARO: hot flashes (15% vs 10%), skin rash (13% vs 2%), diarrhea (21% vs 5%), fatigue (46% vs 18%) and gynecomastia (52% vs 2%). Global health related quality of life remained stable in both groups, but the hormonal treatment-related symptoms worsened in the SBRT+DARO arm in the first 6 months, recuperating within the next 6 months.
Conclusion: The addition of 24 weeks of darolutamide to SBRT only postpones disease progression for the duration of the treatment in recurrent PSMA PET-detected oligometastatic hormone-sensitive prostate cancer. Keywords: Prostate cancer, PSMA PET, oligometastases Proffered Paper 5560 Acute toxicity in PACE-NODES: A randomised trial of 5 fraction (f) prostate stereotactic body radiotherapy (SBRT) vs 5f prostate and pelvic nodal SBRT Angela Pathmanathan 1 , Suneil Jain 2 , Fay H Cafferty 3 , Darren Leaning 4 , Andrew Chan 5 , Ramachandran Venkitaraman 6 , Mohini Varughese 7 , Miguel Panades 8 , Tim Ward 9 , Alison Tree 1,10 , Isabel Syndikus 11 , John Staffurth 12 , Yee Pei Song 13 , Julia Pugh 3 , Olivia Naismith 1 , Vedang Murthy 14 , Conor K McGarry 2 , Ken McBride 9 , Paul Kelly 15 , Monisha Dewan 3 , Harper Clees- Baron 3 , Stephanie Burnett 3 , Stephanie Brown 3 , Emma Hall 3 , Nicholas van As 1,10 1 The Royal Marsden Hospitals NHS FT, The Royal Marsden Hospital, London, United Kingdom. 2 Belfast Health and Social Care Trust, Queen's University Belfast, Belfast, United Kingdom. 3 The Institute of Cancer research, Clinical Trials and Statistics Unit, London, United Kingdom. 4 South Tees NHS FT, The James Cook University Hospital, Middlesbrough, United Kingdom. 5 University Hospitals Coventry & Warwickshire NHS Trust, University Hospitals Coventry & Warwickshire, Warwickshire, United Kingdom. 6 East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital, Ipswich, United Kingdom. 7 Royal Devon University Healthcare NHS FT, Royal Devon & Exeter Hospital, Exeter, United Kingdom. 8 Lincolnshire Community and Hospitals NHS Group, Lincoln Country Hospital, Lincoln, United Kingdom. 9 Patient and Public Involvement (PPI) representative, Independent, London, United Kingdom. 10 The Institute of Cancer research, The Institute of Cancer Research, London,
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