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Completed

NCT Number: NCT03675529

The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy.

Background and purpose: The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer undergoing radical prostatectomy.

The primary hypothesis is that exercise reduces tumor hypoxia and that the reduction is greater in patients performing one acute high intensity exercise bout compared to no training controls.

The investigators have not been able to identify any prior or current randomized trials investigating exercise and tumor hypoxia, and believe that such research is warranted and would be of great importance. Moreover there is a need for studies including biological measurements to allow a full assessment of the effect of exercise on diverse biomarkers and mechanistic pathways, which may influence cancer survival.

Subjects: Patients with histologically verified prostate adenocarcinoma scheduled for radical prostatectomy at Urologic Department, Rigshospitalet, Copenhagen, Denmark.

Methods: In this randomized controlled pilot study 30 patients with localized prostate cancer undergoing radical prostatectomy will be included and randomized 2:1 to either one single acute High Intensity Interval Training bout or usual care and no training the day prior to radical prostatectomy.

All patients will undergo assessment at inclusion (baseline) and the day prior to surgery.

Assessment includes: anthropometrics; blood pressure; resting hearth rate; hip and waist circumference, ECG, quality of life by self-report questionnaires; fasting blood sample measuring PSA (prostate specific antigen), cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose and inflammatory markers.

All patients will receive one dose of pimonidazole hydrochloride (500 mg per m2 body surface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate.

Biological tissue from tumor (primary prostate biopsies) will also be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Physical Activity Research, Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

About this study

The purpose of this study is to investigate the effect of one acute exercise bout on tumor hypoxia in patients with localized prostate cancer randomized to one single acute I) High Intensity Interval Training bout compared to (II) usual care and no training prior to radical prostatectomy.

In addition to this the aim is to investigate the effect of one exercise bout on tumor vessel morphology and to investigate the effect of one acute exercise bout on intratumoral immune cell infiltration and to investigate the modulation of tumor-metabolism, -biology and signaling in patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.

Moreover this study will explore the acute response in immune cells, hormones and cytokines in blood samples taken before, during and after a single exercise session, and will collect physiological (metabolic profile and metabolic inflammatory markers) and psycho-social (e.g. fatigue, emotional well-being, anxiety) information regarding patients randomized to either one acute High Intensity Interval Training bout compared to usual care and no training, the day prior to surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men with histologically verified localized prostate adenocarcinoma undergoing curative intended radical prostatectomy.

Exclusion criteria

  • Age: <18 years
  • Any other known malignancy requiring active treatment
  • Performance status > 1
  • Allergy to pimonidazole
  • Ongoing treatment with beta blockers
  • Physical disabilities precluding physical testing and/or exercise
  • Inability to read and understand Danish

Treatment and study plan

High Intensity Interval Training bout

Behavioral

Patients randomized to the HIIT bout will perform one single supervised High Intensity Interval Training bout consisting firstly of a wattmax test on a stationary bike, in order to set the training intensity. This is followed by 10 minutes at low intensity at approximately 30% of wattmax. Subsequently patients will perform 16 min with 4 cycles with High and Low intensity. HI intervals consisting of 1 min with 100% of wattmax followed by 3 min recovery with the intensity load of 30% of wattmax.

Primary outcomes

  1. Tumor hypoxia

    Time frame: At prostatectomy

    Quantification of tumor hypoxia will be assessed using pimonidazole staining

Secondary outcomes

  1. Intratumoral immune cell infiltration

    Time frame: Primary prostate biopsies and until radical prostatectomy

    Intratumoral immune cell infiltration will be quantified using histological analyses

  2. Tumor vessel morphology

    Time frame: Primary prostate biopsies and until radical prostatectomy

    Tumor vessel morphology will be evaluated using histological analyses

  3. Tumor metabolism-, biology and signaling

    Time frame: Primary prostate biopsies and until radical prostatectomy

    Tumor samples will undergo proteomic analyses in order to uncover potential upregulated biomarkers

  4. Changes in immune cells during an acute exercise bout

    Time frame: From start of exercise bout and until 60 minutes post exercise

    Changes in immune cells during an acute exercise bout will be measured in blood samples using flowcytometry

  5. Changes in epinephrine concentration

    Time frame: From start of exercise bout and until 60 minutes post exercise

    Concentration of epinephrine will be measured in blood samples by radioimmunoassay analyses.

  6. Changes in nor-epinephrine concentration

    Time frame: From start of exercise bout and until 60 minutes post exercise

    Concentration of nor-epinephrine will be measured in blood samples by radioimmunoassay analyses.

  7. Changes in various interleukines

    Time frame: From start of exercise bout and until 60 minutes post exercise

    Concentration of various interleukines will be measured in blood samples by measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.

  8. Changes in Tumor Necrosis Factor alpha (TNFa) concentration

    Time frame: From start of exercise bout and until 60 minutes post exercise

    Concentrations of TNFa will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.

  9. Changes in Interferon Gamma (IFNγ) concentration

    Time frame: From start of exercise bout and until 60 minutes post exercise

    Concentrations of IFNγ will be measured in blood samples by Enzyme-Linked Immunosorbent Assay (ELISA) analyses.

  10. Concentration of C-reactive Protein (CRP)

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentration of CRP will be measured in fasting blood sample by standard laboratory methods.

  11. Total plasma cholesterol concentration

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentrations of total cholesterol will be measured in fasting blood samples by standard laboratory methods.

  12. Plasma LDL-Cholesterol concentration

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentrations of LDL- cholesterol will be measured in fasting blood samples by standard laboratory methods.

  13. Plasma HDL-Cholesterol concentration

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentrations of HDL- cholesterol will be measured in fasting blood samples by standard laboratory methods.

  14. Plasma triglyceride concentrations

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentrations of triglycerides will be measured in fasting blood samples by standard laboratory methods.

  15. HbA1C concentration

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentrations of HbA1C will be measured in fasting blood samples by standard laboratory methods.

  16. Plasma Insulin concentration

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentrations of insulin will be measured in fasting blood samples by standard laboratory methods.

  17. Plasma Glucose concentration

    Time frame: Blood sampling on the day of radical prostatectomy

    Concentrations of glucose will be measured in fasting blood samples by standard laboratory methods.

  18. Wattmax-test

    Time frame: At baseline assessment

    The participants in the HIIT group will undergo a maximal graded exercise test on a bicycle ergometer for evaluation of cardiovascular function and determination of the maximum watt (wattmax). The test starts with a 3 min warm up at 70 watt (the watts may have to be adjusted to the individual fitness level). Warm up is immediately followed by a 20 watt increase every 1 min until exhaustion. The maximum watt will be calculated.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy - a Randomized Controlled Pilot Study

Acronym: SHOR-TEST

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2018
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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