RGN, PGDip, MSc
Research Nurse/Associate - ProtecT Trial
I am a research nurse/associate 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. The median 10 year outcomes were published in 2016 with the 15 year outcomes anticipated to be in the public domain by 2021.
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 the University of Oxford. Data collection/verification is carried out by the dept of Population Health Sciences at the University of Bristol. There are 9 UK clinical centres. The trial closed to recruitment in 2009 is now in the follow up phase. Until December 2017 my role was to supplement the role of the trial coordinator [based in Bristol] by providing nursing support to the trial - my tasks included on-site support, monitoring, training and trial development. Data collection by local staff ceased in December 2017 and therefore my current role is as the a field worker collecting outcome data from the 9 UK-centres. I have letters of access/honorary research contracts in the individual NHS Trusts to enable access to the site and outcome data required (medical records, including digital records). My base is at the Royal Hallamshire Hospital in Sheffield. Located centrally, Sheffield is a perfect base from which to coordinate UK-wide field visits.
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.
Active monitoring, radical prostatectomy and radical radiotherapy in PSA-detected clinically localised prostate cancer: the ProtecT three-arm RCT.
Hamdy FC. et al, (2020), Health Technol Assess, 24, 1 - 176
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