title: Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial.
abstract: BACKGROUND
  A growing body of observational evidence suggests that nutritional and physical activity interventions are associated with beneficial outcomes for men with prostate cancer, including brisk walking, lycopene intake, increased fruit and vegetable intake and reduced dairy consumption. However, randomised controlled trial data are limited. The 'Prostate Cancer: Evidence of Exercise and Nutrition Trial' investigates the feasibility of recruiting and randomising men diagnosed with localised prostate cancer and eligible for radical prostatectomy to interventions that modify nutrition and physical activity. The primary outcomes are randomisation rates and adherence to the interventions at 6 months following randomisation. The secondary outcomes are intervention tolerability, trial retention, change in prostate specific antigen level, change in diet, change in general physical activity levels, insulin-like growth factor levels, and a range of related outcomes, including quality of life measures.
  
  
  METHODS
  The trial is factorial, randomising men to both a physical activity (brisk walking or control) and nutritional (lycopene supplementation or increased fruit and vegetables with reduced dairy consumption or control) intervention. The trial has two phases: men are enrolled into a cohort study prior to radical prostatectomy, and then consented after radical prostatectomy into a randomised controlled trial. Data are collected at four time points (cohort baseline, true trial baseline and 3 and 6 months post-randomisation).
  
  
  CONCLUSIONS
  The Prostate Cancer: Evidence of Exercise and Nutrition Trial aims to determine whether men with localised prostate cancer who are scheduled for radical prostatectomy can be recruited into a cohort and subsequently randomised to a 6-month nutrition and physical activity intervention trial. If successful, this feasibility trial will inform a larger trial to investigate whether this population will gain clinical benefit from long-term nutritional and physical activity interventions post-surgery. Prostate Cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) is registered on the ISRCTN registry, ref number ISRCTN99048944. Date of registration 17 November 2014.
authors.affiliation: NIHR Biomedical Research Unit in Nutrition, Diet and Lifestyle, Level 3, University Hospitals Bristol Education Centre, Upper Maudlin Street, Bristol, BS2 8AE, UK. Lucy.Hackshaw@bristol.ac.uk.|School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Lucy.Hackshaw@bristol.ac.uk.
authors.forename: Lucy
authors.initials: L
authors.lastname: Hackshaw-McGeagh
authors.affiliation: NIHR Biomedical Research Unit in Nutrition, Diet and Lifestyle, Level 3, University Hospitals Bristol Education Centre, Upper Maudlin Street, Bristol, BS2 8AE, UK. athene.lane@bristol.ac.uk.|School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. athene.lane@bristol.ac.uk.
authors.forename: J Athene
authors.initials: JA
authors.lastname: Lane
authors.affiliation: Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. rajpersad@bristolurology.com.
authors.forename: Raj
authors.initials: R
authors.lastname: Persad
authors.affiliation: Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. David.Gillatt@nbt.nhs.uk.
authors.forename: David
authors.initials: D
authors.lastname: Gillatt
authors.affiliation: School of Clinical Sciences, University of Bristol, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, BS10 5NB, UK. jeff.holly@bristol.ac.uk.
authors.forename: Jeff M P
authors.initials: JM
authors.lastname: Holly
authors.affiliation: Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. Anthony.Koupparis@nbt.nhs.uk.
authors.forename: Anthony
authors.initials: A
authors.lastname: Koupparis
authors.affiliation: Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. Edward.Rowe@nbt.nhs.uk.
authors.forename: Edward
authors.initials: E
authors.lastname: Rowe
authors.affiliation: North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. Lyndsey.Johnson@nbt.nhs.uk.
authors.forename: Lyndsey
authors.initials: L
authors.lastname: Johnston
authors.affiliation: North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. jenny.cloete@nbt.nhs.uk.
authors.forename: Jenny
authors.initials: J
authors.lastname: Cloete
authors.affiliation: North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. Constance.Shiridzinomwa@nbt.nhs.uk.
authors.forename: Constance
authors.initials: C
authors.lastname: Shiridzinomwa
authors.affiliation: Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. Paul.Abrams@nbt.nhs.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Abrams
authors.affiliation: NIHR Biomedical Research Unit in Nutrition, Diet and Lifestyle, Level 3, University Hospitals Bristol Education Centre, Upper Maudlin Street, Bristol, BS2 8AE, UK. Chris.Penfold@bristol.ac.uk.
authors.forename: Chris M
authors.initials: CM
authors.lastname: Penfold
authors.affiliation: Bristol Urological Institute, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. Amit.Bahl@uhbristol.nhs.uk.|University Hospital Bristol NHS Trust, Bristol Haematology and Oncology Centre, Horfield Road, Bristol, BS2 8ED, UK. Amit.Bahl@uhbristol.nhs.uk.
authors.forename: Amit
authors.initials: A
authors.lastname: Bahl
authors.affiliation: Cellular Pathology, North Bristol NHS Trust, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, Avon, BS10 5NB, UK. Jon.Oxley@nbt.nhs.uk.
authors.forename: Jon
authors.initials: J
authors.lastname: Oxley
authors.affiliation: School of Clinical Sciences, University of Bristol, Southmead Hospital, Southmead Way, Westbury-on-trym, Bristol, BS10 5NB, UK. Claire.M.Perks@bristol.ac.uk.
authors.forename: Claire M
authors.initials: CM
authors.lastname: Perks
authors.affiliation: NIHR Biomedical Research Unit in Nutrition, Diet and Lifestyle, Level 3, University Hospitals Bristol Education Centre, Upper Maudlin Street, Bristol, BS2 8AE, UK. richard.martin@bristol.ac.uk.|School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. richard.martin@bristol.ac.uk.
authors.forename: Richard
authors.initials: R
authors.lastname: Martin
mesh_terms: D002338:Carotenoids / Q000008:administration & dosage; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003611:Dairy Products; D004032:Diet / Q000009:adverse effects; D019587:Dietary Supplements; D004739:England; D015444:Exercise; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D005638:Fruit; D006801:Humans; D000077276:Lycopene; D008297:Male; D009752:Nutritional Status; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000178:diet therapy* / Q000503:physiopathology; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014675:Vegetables; D016138:Walking
chemical_list: D002338:Carotenoids; D000077276:Lycopene