Patients undergoing prostate radiotherapy with an enlarged prostate can have short-term and long-term urinary complications. Currently, transurethral resection of the prostate (TURP) is the mainstay surgical intervention for men with urinary symptoms due to an enlarged prostate prior to radiotherapy. UroLift (NeoTract, Pleasanton, CA, USA) is a recent minimally invasive alternative, widely used in benign disease but is untested in men with prostate cancer.
A multicentre, two-arm study designed in collaboration with a Patient Reference Group to assess the feasibility of randomising men with prostate cancer and coexisting urinary symptoms due to prostate enlargement to TURP or UroLift ahead of radiotherapy. 45 patients will be enrolled and randomised (1:1) using a computer-generated programme to TURP or UroLift. Recruitment and retention will be assessed over a 12 month period. Information on clinical outcomes, adverse events and costs will be collected. Clinical outcomes and patient reported outcome measures will be measured at baseline, 6 weeks postintervention and 3 months following radiotherapy. A further 12 in-depth interviews will be conducted with a subset of patients to assess acceptability using the Theoretical Framework of Acceptability. Descriptive analysis on all outcomes will be performed using Stata (StataCorp V.2021).
The trial has been approved by the Research Ethics Committee (REC) NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW). The results will be published in peer-reviewed journals, presented at national meetings and disseminated to patients via social media, charity and hospital websites.
NCT05840549.
BMJ open. 2023 Oct 06*** epublish ***
Kathie Wong, Netty Kinsella, Jai Seth, David Nicol, Declan Cahill, Ramanathan Kasivisvanathan, John Withington, Masood Moghul, Charlotte Louise Moss, Mieke Van Hemelrijck, Kyriaki Giorgakoudi, Chris Cottrell, Emma Yates, Vincent Khoo, Nicholas D James
Urology, The Royal Marsden NHS Foundation Trust, London, UK ., Urology, The Royal Marsden NHS Foundation Trust, London, UK., Urology, St George's Hospital, London, UK., Department of Surgery and Anaesthesia, Royal Marsden NHS Foundation Trust, London, UK., Urology, University College London, London, UK., Translational Oncology and Urology Research, King's College London, London, UK., City, University of London, London, UK., Royal Marsden Hospital NHS Trust, London, UK., Department of Oncology, Royal Marsden NHS Foundation Trust, London, UK.