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

NCT03675529 | Completed

• 1 other identifier: H-18020711
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate neoplasm; exercise; high intensity interval training; tumor hypoxia; immune cells

Outcome Measures

Primary Outcomes (1)

• Tumor hypoxia

  Quantification of tumor hypoxia will be assessed using pimonidazole staining

  At prostatectomy

Secondary Outcomes (18)

• Intratumoral immune cell infiltration

  Primary prostate biopsies and until radical prostatectomy

• Tumor vessel morphology

  Primary prostate biopsies and until radical prostatectomy

• Tumor metabolism-, biology and signaling

  Primary prostate biopsies and until radical prostatectomy

• Changes in immune cells during an acute exercise bout

  From start of exercise bout and until 60 minutes post exercise

• Changes in epinephrine concentration

  From start of exercise bout and until 60 minutes post exercise

Study Arms (2)

High Intensity Interval Training bout

EXPERIMENTAL

Patients randomized to this group will perform a wattmax test immediately followed by 4 intervals of high and low intensity based on percentage of wattmax. Immediately after the exercise bout is finished 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 by radical prostatectomy the following day.

Behavioral: High Intensity Interval Training bout

Controls (usual care)

NO INTERVENTION

Patients randomized to the control group will not be doing any exercise, but will after approximately 35 min from baseline blood sampling receive one dose of pimonidazole hydrochloride (500 mg per m2 bodysurface) in order to quantify tumor hypoxia by pathological analyses after removal of the prostate by radical prostatectomy the following day.

Interventions

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.

High Intensity Interval Training bout

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Center for Physical Activity Research, Copenhagen University Hospital

Copenhagen, DK-2100, Denmark

Location

Related Publications (2)

• Djurhuus SS, Schauer T, Simonsen C, Toft BG, Jensen ARD, Erler JT, Roder MA, Hojman P, Brasso K, Christensen JF. Effects of acute exercise training on tumor outcomes in men with localized prostate cancer: A randomized controlled trial. Physiol Rep. 2022 Oct;10(19):e15408. doi: 10.14814/phy2.15408.

  PMID: 36199257 DERIVED

• Schauer T, Djurhuus SS, Simonsen C, Brasso K, Christensen JF. The effects of acute exercise and inflammation on immune function in early-stage prostate cancer. Brain Behav Immun Health. 2022 Sep 7;25:100508. doi: 10.1016/j.bbih.2022.100508. eCollection 2022 Nov.

  PMID: 36133956 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Sissal S Djurhuus, MD

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 18, 2018
• Study Start: October 1, 2018
• Primary Completion: November 24, 2019
• Study Completion: November 24, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Locations

DK (1)