Aims to evaluate the effectiveness, cost-effectiveness and acceptability of treatments for men with localised prostate cancer in a pragmatic randomised controlled trial [RCT].
Background: There are currently no plans to introduce screening for prostate cancer in the UK because there is a lack of evidence that it would improve the quantity and quality of men's lives. One concern is the lack of evidence on the effectiveness of treatments. In particular, no survival advantage has been shown for any major treatment, and each can result in damaging complications and outcomes The aim of the ProtecT trial is to find out which treatments are best.The three treatments available in the ProtecT trial are: conformal radiotherapy, surgery and active monitoring. There are two components in the trial:
1. Early detection of prostate cancer with participants invited from general practices to attend clinics to be informed about the uncertainties of treatment and the implications of testing
2. A three-arm randomised trial of treatments for participants with localised prostate cancer - the primary analysis is to assess definite or probable prostate cancer specific mortality. Secondary analysis focuses on overall survival, disease progression (biochemical and clinical), treatment complications, lower urinary tract symptoms, psychological impact (detection and treatment), resource use and collection of samples for basic science (ProMPT study - see below).
Trial progress: A feasibility study was conducted between 1999 and 2001, recruitment was between 1999 and 2009. The trial is currently in the follow-up phase. 10-year outcomes were published in 2016 with 15 year outcomes anticipated to be in the public domain in 2021. The trial is also linked to the ProMPT study and has a secondary objective to collect samples suitable for basic science research. These samples have been stored in two mirror image bio-repositories at the Universities of Cambridge and Oxford, though will be moved to a central location in 2020 when the ethics agreement for ProMPT expires and the samples will then be managed under the Oxford HTA licence.
Trial management: The trial has nine UK centres and is funded by the National Institute for Health Research [NIHR] Health Technology Assessment Programme [HTA]. Sponsorship is provided by the University of Oxford and the chief investigator is Professor Freddie Hamdy. The data management and much of the day to day activity is carried out by the department of Population Health Sciences at the University of Bristol - the trial coordinator is based here (Prof Athene Lane).
ProtecT Trial centres:
Bristol, Southmead Hospital, Lead Urologist, Mr Edward Rowe
- Newcastle, Freeman Hospital, Lead Urologist, Mr Edgar Paez
- Sheffield, Royal Hallamshire Hospital, Lead Urologist, Prof Derek Rosario
- Birmingham, Queen Elizabeth Hospital, Lead Urologist, Mr Alan Doherty
- Cardiff, University Hospital of Wales, Lead Urologist, Mr Owen Hughes
- Edinburgh, Western General Hospital, Lead Urologist, Mr Prasad Bollina
- Cambridge, Addenbrookes Hospital, Lead Urologist, Mr Vincent Gnanapragasam
- Leicester, Leicester General Hospital, Lead Urologist, Prof Roger Kockelbergh
- Leeds, St James Hospital, Lead Urologist, Mr Alan Paul
Professor Jenny Donovan, Head of School, School of Social and Community Medicine, University of Bristol
- Professor Freddie Hamdy, Head of Nuffield Department of Surgical Sciences, University of Oxford
- Professor David Neal, Professor of Surgical Oncology, Addenbrooke's Hospital, Cambridge
Prof Athene Lane, Senior Research Fellow, School of Social and Community Medicine, University of Bristol