Clinical trial NCT03365076: Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)
Official title: Exercise for Improving Prostate Oxygenation in Prostate Tumors (Exipox)-Study - a Pilot Study Exploring Exercise as a Way of Improving Cure With Radical Radiotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Physical Activity
Hypoxia
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University of Tromso
name: Northern Health Authority
First posted: 2017-12-07
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized control trial. Randomization 1:1
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Hypoxic fraction-gold standard
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Side effects
timeFrame: through study completion, an average of 1 year
measure: Hypoxic fraction-MRI
timeFrame: through study completion, an average of 1 year
measure: Health related Quality of life
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: UNN HF Tromsø
name: Sigve Andersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: