Prostate cancer: Exercise and Metformin Trial (Pre-EMpT) V1 11.01.2018
Research type
Research Study
Full title
Pre-EMpT Prostate cancer – Exercise and Metformin Trial; a feasibility study
IRAS ID
229118
Contact name
Athene Lane
Contact email
Sponsor organisation
University of Bristol
ISRCTN Number
ISRCTN13543667
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Pre-EMpT is an open label 2x2 feasibility randomised control trial (RCT). This study aims to investigate the feasibility of randomising men, diagnosed with localised prostate cancer who are to be treated with radiotherapy, radical prostatectomy or active surveilence, into an RCT of physical activity and metformin. The secondary objectives will include exploring: Intervention tolerability; Trial retention; Feasibility of measuring prostate specific antigen (PSA) level; Feasibility of measuring insulin-like growth factor I (IGF-I) level; Feasibility of demonstrating gene expression profiles in prostate tissue and blood; Feasibility of assessing physical activity levels; Urinary symptoms; Psychological factors; Health beliefs; Patient function and bother after prostate cancer treatment; Quality of life measures; Cancer related fatigue; General lifestyle factors; Weight and body mass index; Qualitative data.
Participants will be randomised within their treatment group i.e. radiotherapy, radical prostatectomy and active surveillance.
All participants will be randomised to both a physical activity level and a metformin level.At the physical activity level, participants will be randomised to a brisk walking intervention arm or a physical activity control arm. The intervention consists of walking at a brisk pace for 30 minutes, on at least 5 days a week, on top of normal physical activity, with the additional aim to walk 10,000 steps every day. In addition to this, a proportion of men within the brisk walking intervention will additionally be provided with a wrist worn activity monitor to wear for the duration of the intervention. These monitors will allow us to explore the feasibility of men undergoing different treatments for prostate cancer using wearable activity trackers, with the intention of examining the impact of the activity trackers on adherence to physical activity, and prostate specific, and other, outcomes.
In the metformin level, participants will be randomised to a once daily 500mg slow release metformin tablet arm or a metformin control arm.REC name
Wales REC 1
REC reference
18/WA/0067
Date of REC Opinion
18 Apr 2018
REC opinion
Further Information Favourable Opinion