PROstaTe Cancer - Exercise-STudy (PRO-TEST)

NCT02954783 | Completed

• 1 other identifier: H-16034670
• 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 exercise on intratumoral natural killer (NK)-cell variability in patients with localized prostate cancer undergoing radical prostatectomy. The primary hypothesis is that exercise induces epinephrine-mediated intratumoral natural killer (NK)-cell infiltration in patients with localized prostate cancer, and that the infiltration is greater in patients performing High Intensity Interval Training compared to usual care controls. Currently there is a lack of randomized controlled trials examining different types of exercise in patients with localized prostate cancer. 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 High Intensity Interval Training (HIIT) exercise intervention or observational control receiving usual care from inclusion and until planned surgery (radical prostatectomy). All patients will undergo assessments at inclusion (baseline) and at follow-up after the exercise intervention period (maximum 8 weeks) 3-5 days prior to surgery. Assessments include: anthropometrics; blood pressure; resting hearth rate; cardiorespiratory fitness by cardiopulmonary exercise test (VO2 peak.); body composition by DXA scan; quality of life by self-report questionnaires; fasting blood sample measuring cholesterol, triglycerides, insulin, c-peptide, HbA1c, glucose, hormones and inflammatory markers. Biological tissue from tumor (primary prostate biopsies) will be retrieved from the respective local pathological departments and from the perioperative prostate specimen and sent to protocol analyses.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Localized; Exercise; Physical activity; Natural killer cells; Immune cells

Outcome Measures

Primary Outcomes (1)

• Variability in intratumoral Natural Killer (NK)-cell infiltration

  Natural killer (NK)-cell infiltration will be quantified using histological analyses.

  Primary prostate biopsies and up to 8 weeks

Secondary Outcomes (27)

• Tumor vessel morphology

  Primary prostate biopsies and up to 8 weeks

• Tumor-metabolism, - biology and signaling

  Primary prostate biopsies and up to 8 weeks

• Changes in immune cells

  Baseline and up to 8 weeks

• Changes in epinephrine concentration

  Baseline and up to 8 weeks

• Changes in nor-epinephrine concentration

  Baseline and up to 8 weeks

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

The HIIT-group will receive usual care plus a supervised aerobic High Intensity Interval Training program consisting of 4 weekly sessions of approximately 35 minutes.

Behavioral: High Intensity Interval Training

Usual Care Observational Control

ACTIVE COMPARATOR

Patients randomized to usual care control will receive the standard patient care program as provided by the Department of Urology, Rigshospitalet.

Behavioral: Usual Care Observational Control

Interventions

High Intensity Interval Training BEHAVIORAL

Supervised aerobic High Intensity Interval Training program consisting of 4 weekly sessions of approximately 35 minutes. Patients will perform a test of maximum cardio-respiratory (VO2 peak test). Using the patient's individual wattmax, a personalized exercise program will be prescribed. After a light warm-up, patients will perform 25 min of aerobic high intensity interval training on a stationary bicycle, intervals will consist of cycles of HI intervals with 120% of wattmax for 1 min followed by recovery for 3 min at 30% of wattmax. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load.

High Intensity Interval Training

Usual Care Observational Control BEHAVIORAL

The reference group will receive the standard patient care program as provided by the Department of Urology, Rigshospitalet.This includes information regarding smoking cessation and alcohol reduction and a physiotherapist consultation regarding pelvic floor exercises. This group is allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise program. This will be monitored by self-report.

Usual Care Observational Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically verified localized prostate cancer
• Eligible for curative radical prostatectomy

You may not qualify if:

• Any other known malignancy requiring active treatment
• Performance status \> 1
• 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 (1)

• Djurhuus SS, Simonsen C, Toft BG, Thomsen SN, Wielsoe S, Roder MA, Hasselager T, Ostergren PB, Jakobsen H, Pedersen BK, Hojman P, Brasso K, Christensen JF. Exercise training to increase tumour natural killer-cell infiltration in men with localised prostate cancer: a randomised controlled trial. BJU Int. 2023 Jan;131(1):116-124. doi: 10.1111/bju.15842. Epub 2022 Jul 18.

  PMID: 35753072 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 3, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

DK (1)