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
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 with primary analysis planned for the end of 2015. The primary objective is to assess definite or probable prostate cancer specific mortality at a median of 10 years following randomisation. The trial is also linked to the ProMPT study and has a secondary objective to collect samples suitable for basic science research. These samples are stored in two mirror image bio-repositories at the Universities of Cambridge and Oxford.
Trial management: The trial has nine UK centres and is funded by the National Institute for Health Research [NIHR] Health Technology Assessment Programme [HTA]. Funding is allocated to 3 'hubs' - the Universities of Bristol, Cambridge and Oxford. Sponsorship is provided by the University of Oxford and the chief investigator is Professor Freddie Hamdy. The research activity is coordinated via the School of Social and Community Medicine, University of Bristol. The Oxford hub has funding to employ and support research staff at 4 of the ProtecT trial centres: lead nurse in brackets - Birmingham [Pauline Thompson], Leeds [Debbie Cooper], Leicester [Sue Bonnington] and Sheffield [Jo Howson].
ProtecT Trial centres:
Bristol, Southmead Hospital, Lead Urologist, Mr David Gillatt
- Newcastle, Freeman Hospital, Lead Urologist, Mr Philip Powell
- Sheffield, Royal Hallamshire Hospital, Lead Urologist, Mr Derek Rosario
- Birmingham, Queen Elizabeth Hospital, Lead Urologist, Mr Alan Doherty
- Cardiff, University Hospital of Wales, Lead Urologist, Professor Howard Kynaston
- Edinburgh, Western General Hospital, Lead Urologist, Mr Prasad Bollina
- Cambridge, Addenbrookes Hospital, Lead Urologist, Professor David Neal
- Leicester, Leicester General Hospital, Lead Urologist, Mr 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
Dr Athene Lane, Senior Research Fellow, School of Social and Community Medicine, University of Bristol