Prostate Cancer
Conditions
Brief summary
Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.
Interventions
BEHAVIORALAerobic exercise training
Aerobic exercise training will be undertaken for 12 months, combining supervised and independent exercise sessions. Behaviour change counselling will take place bi-monthly, either via face to face sessions during exercise or via telephone by study clinical exercise specialist according to participant preference.
BEHAVIORALPlacebo surveillance and written exercise guidelines
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Sponsors
Sheffield Hallam University
University of Sheffield
Queen Mary University of London
University College London Hospitals
Institute of Cancer Research, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
In accordance with NICE active surveillance guidelines, men: * Who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months * With histologically confirmed low or intermediate risk prostate cancer, Gleason score ≤7 (3+4, not 4+3) * With up to T2a clinical stage tumours * With pre-treatment PSA ≤20 ng/mL * Who are willing to participate in optimal active surveillance and provide written informed consent * With life expectancy of ≥10 years
Exclusion criteria
Men: * With unstable angina * With uncontrolled hypertension * With recent myocardial infarction (within the past 6 months) * With pacemakers * Already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded * With any other physical or mental limitation preventing participation in trial assessments * Participating in other clinical trials which might bias the evaluation of the primary objectives of the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by rate of recruitment | 36 months | The rate of recruitment will be measured by comparing the number of patients screended to the number of patients recruited. This will allow us to asses if a future full-scale trial is feasible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by Intervention adherence | 36 months | Intervention adherence will be assessed using an exercise log book and heart rate monitor to objectively record independent exercise behaviour and support adherence and compliance. |
Countries
United Kingdom
Outcome results
None listed