Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer: the PANTERA Trial (Prostate cAncer Novel ThERApy)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Aerobic exercise training
* Behavioral: Placebo surveillance and written exercise guidelines


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>12 months of aerobic exercise training with behaviour change support | Behavioral: Aerobic exercise training<br>* 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.<br>|
| Placebo Comparator: Comparison<br>Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer | Behavioral: Placebo surveillance and written exercise guidelines<br>* Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by rate of recruitment | 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. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by Intervention adherence | 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. | 36 months |