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Abstract

Introduction
Patients undergoing prostate radiotherapy with an enlarged prostate can have short 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 Inc., Pleasanton, CA USA) is a recent minimally invasive alternative, widely used in benign disease but is untested in men with prostate cancer.
Methods and Analysis
A multi-centre, two-arm study designed in collaboration with a Patient Reference Group to assess the feasibility of randomising men with prostate cancer and co-existing 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 (PROMs) will be measured at baseline, six-weeks post-intervention and three 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 2021).
Ethics and Dissemination
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.

Publication Type:	Article
Additional Information:	© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
Publisher Keywords:	Urolift, transurethral resection of prostate, prostate radiotherapy, prostate cancer, urinary symptoms, bladder outlet obstruction
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Departments:	School of Health & Psychological Sciences > Healthcare Services Research & Management
SWORD Depositor:	Symplectic Administrator

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