Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer
NCT ID: NCT02409212
Last Updated: 2019-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2015-05-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
12 months of aerobic exercise training with behaviour change support
Aerobic 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.
Comparison
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Placebo surveillance and written exercise guidelines
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Interventions
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Aerobic 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.
Placebo surveillance and written exercise guidelines
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
MALE
No
Sponsors
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Sheffield Hallam University
OTHER
University of Sheffield
OTHER
Queen Mary University of London
OTHER
University College London Hospitals
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Derek Rosario, MD
Role: PRINCIPAL_INVESTIGATOR
University of Sheffield / Sheffield Teaching Hospitals
Locations
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Sheffield Teaching Hospitals NHS Trust
Sheffield, South Yorkshire, United Kingdom
Countries
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Other Identifiers
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STH 18624
Identifier Type: -
Identifier Source: org_study_id
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