- The ProtecT Trial Research Group
RGN, PGDip, MSc
Coordinating Lead Nurse, ProtecT Trial
I am coordinating lead nurse for the Prostate testing for cancer and Treatment trial [ProtecT]. The aim of the Protect trial is to assess the effectiveness, cost-effectiveness and acceptability of treatments for men with localised prostate cancer in a pragmatic randomised controlled trial. It compares three treatments - active monitoring, radical prostatectomy and radical radiotherapy. It is funded by the NIHR HTA programme and the primary analysis is due at the end of 2015 [median 10 year follow-up point].
This research is of world-wide importance as prostate cancer is a major public health issue. The natural ageing of the population combined with continued and widespread use of improved diagnostic tests such as PSA are resulting in an increase in the numbers diagnosed with localised prostate cancer. However, there is lack of evidence about the effectiveness of treatments for screen-detected disease - in particular, no survival advantage has been shown for any major treatment, and each can result in damaging complications and outcomes.
The Chief Investigator for the ProtecT trial is Prof Freddie Hamdy. It is sponsored by Oxford University and the research coordination is done via the School of Social and Community Medicine, University of Bristol. There are 9 UK clinical centres. The trial closed to recruitment in 2009 is now in the follow up phase. My role is to supplement the role of the trial coordinator [based in Bristol] by providing nursing support to the trial - my tasks include on-site support, monitoring, training and trial development. I am on the trial steering committee. My base is in Sheffield, though I travel most weeks.
Though the main trial report is not due until 2015/16 the trial has already generated numerous publications, citations and allied research projects. My particular interests have been in the development of an internal peer-review monitoring programme [PRIME] in order to assist centres with GCP adherence and provide staff support, and in the development of recruitment strategies for complex trials.
Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial.
Wade J. et al, (2015), BMJ Open, 5
A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance.
Lane JA. et al, (2011), J Clin Epidemiol, 64, 628 - 636