Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)

Study Overview
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Brief Summary
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Previous research into metabolic and hypoxic markers has found evidence of preclinical impact of exercise on prostate tumor blood flow and oxygenation in rodents . As radiotherapy is a frequently used and effective therapy for and that sufficient oxygenation is decisive to the effect of radiotherapy, an underlying hypothesis that aerobic exercise might improve treatment efficacy of radiotherapy in prostate cancer is put forward. This study has a potential challenging intervention, but a potential very high gain as it includes active patient participation to significantly improve outcome of radical radiotherapy.

Detailed Description
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A randomized controlled trial with four to five weeks of moderate/high intensity aerobic exercise program compared with no intervention for 32 prostate cancer patients waiting for radical prostatectomy at the University Hospital of North Norway (UNN). 16 patients will undergo the intervention. The expression of the hypoxic marker pimonidazole in the prostate specimens of intervention groups and the control groups will be assessed. This method is considered a reliable tissue oxygenation measurement technique. These patients will also have their and blood flow and hypoxia measured in prostate cancers through magnetic resonance imaging (MRIs).

Official Title
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Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)-Study - a Pilot Study Exploring Exercise as a Way of Improving Cure With Radical Radiotherapy

Conditions
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Prostate Cancer, Physical Activity, Hypoxia

Intervention / Treatment
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* Other: Physical activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed PC planned radical prostatectomy informed consent given above 18 years of age BMI < 30 non-smoker living in Tromso region Exclusion Criteria: Contraindications to the intervention like; heart failure, angina pectoris, respiratory disease limiting possible intervention use of physical supportive devices to aid movement High level of physical activity smoking BMI>30

Ages Eligible for Study
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Minimum Age: 18 Years

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
Interventional Model Description: Open label randomized control trial. Randomization 1:1
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical aerobic intervention<br>The exercise program will be varying between different aerobic activities indoor or outdoor as walking uphill and in stairs in intervals that will differ from session to session to build up the load and progression for these patients. In total, each session will be lasting approximately 45-60 minutes and a physiotherapist or personal trainer will supervise each session. Depending on the participants starting point, there will be 3 supervised session per week and two sessions where the participants do activity with low intensity (walk) by themselves and keep a log with duration (time) and intensity (using Borg scale). | Other: Physical activity<br>* Aerobic physical activity as stated in Arm A<br>|
| No Intervention: Controls<br>These patients will be acting as controls by not been instructed to physical activity. We will not monitor their activity either as this has been shown to increase activity by itself. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxic fraction-gold standard | We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | We will use the Expanded Prostate Cancer Index Composite (EPIC) designed to evaluate patient function and side effects after PC treatment in both groups | through study completion, an average of 1 year | 
| Hypoxic fraction-MRI | We will try to explore the hypoxic fraction by use of magnetic resonance imaging | through study completion, an average of 1 year | 
| Health related Quality of life | We will use EORTC-QLQ30 which is a validated instrument designed to measure quality of life in prostate cancer in both groups | through study completion, an average of 1 year |