Hypoxia, Physical Activity, Prostate Cancer
Conditions
Brief summary
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
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).
Interventions
OTHERPhysical activity
Aerobic physical activity as stated in Arm A
Sponsors
Oslo University Hospital
University of Tromso
Northern Health Authority
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label randomized control trial. Randomization 1:1
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxic fraction-gold standard | through study completion, an average of 1 year | We will measure the hypoxic fraction in prostate cancer specimens by pimonidazole |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | through study completion, an average of 1 year | We will use the Expanded Prostate Cancer Index Composite (EPIC) designed to evaluate patient function and side effects after PC treatment in both groups |
| Hypoxic fraction-MRI | through study completion, an average of 1 year | We will try to explore the hypoxic fraction by use of magnetic resonance imaging |
| Health related Quality of life | through study completion, an average of 1 year | We will use EORTC-QLQ30 which is a validated instrument designed to measure quality of life in prostate cancer in both groups |
Countries
Norway
Outcome results
None listed