COmparing Urolift and Standard Transurethral resection of prostate Ahead of Radiotherapy in men with urinary symptoms secondary to prostate enlargement in Southwest London and North Cumbria (CO-STAR): a study protocol for a randomised feasibility study.
Date
2023-10-06Author
Wong, K
Kinsella, N
Seth, J
Nicol, D
Cahill, D
Kasivisvanathan, R
Withington, J
Moghul, M
Moss, CL
Van Hemelrijck, M
Giorgakoudi, K
Cottrell, C
Yates, E
Khoo, V
James, ND
Type
Journal Article
Metadata
Show full item recordAbstract
INTRODUCTION: 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. METHODS AND ANALYSIS: 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). 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. TRIAL REGISTRATION NUMBER: NCT05840549.
Collections
Subject
Magnetic resonance imaging
ONCOLOGY
Prostate disease
RADIOTHERAPY
Urological tumours
Humans
Male
Feasibility Studies
London
Prostate
Prostatic Hyperplasia
Prostatic Neoplasms
Transurethral Resection of Prostate
Randomized Controlled Trials as Topic
Research team
Prostate & Bladder Cancer
Language
eng
Date accepted
2023-08-09
License start date
2023-10-06
Citation
BMJ Open, 2023, 13 (10), pp. e076621 -
Publisher
BMJ PUBLISHING GROUP
Except where otherwise noted, this item's license is described
as
https://creativecommons.org/licenses/by-nc/4.0
Related items
Showing items related by title, author, creator and subject.
-
Ki-67 and outcome in clinically localised prostate cancer: analysis of conservatively treated prostate cancer patients from the Trans-Atlantic Prostate Group study
Berney, DM; Gopalan, A; Kudahetti, S; Fisher, G; Ambroisine, L; et al. (NATURE PUBLISHING GROUP, 2009-03-17)Treatment decisions after diagnosis of clinically localised prostate cancer are difficult due to variability in tumour behaviour. We therefore examined one of the most promising biomarkers in prostate cancer, Ki-67, in a ... -
Toxicity and Patient-Reported Outcomes of a Phase 2 Randomized Trial of Prostate and Pelvic Lymph Node Versus Prostate only Radiotherapy in Advanced Localised Prostate Cancer (PIVOTAL).
Dearnaley, D; Griffin, CL; Lewis, R; Mayles, P; Mayles, H; et al. (ELSEVIER SCIENCE INC, 2019-03-01)PURPOSE: To establish the toxicity profile of high-dose pelvic lymph node intensity-modulated radiation therapy (IMRT) and to assess whether it is safely deliverable at multiple centers. METHODS AND MATERIALS: In this phase ... -
PIVOTALboost: A phase III randomised controlled trial of prostate and pelvis versus prostate alone radiotherapy with or without prostate boost (CRUK/16/018).
Syndikus, I; Cruickshank, C; Staffurth, J; Tree, A; Henry, A; et al. (ELSEVIER IRELAND LTD, 2020-11-01)•PIVOTALboost evaluates benefits/toxicity of pelvic node RT and focal boost dose escalation.•Unfavourable intermediate/high risk and bulky local disease are most likely to benefit.•Functional MRI imaging is used to select ...