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Completed

NCT Number: NCT03203460

Exercise During Active Surveillance for Prostate Cancer

The broad goal of the Exercise During Active Surveillance for Prostate Cancer (ERASE) trial is to examine the effects of exercise in prostate cancer patients undergoing active surveillance.

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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

University of Alberta

Edmonton, Alberta, T6G2H9, Canada

About this study

The ERASE Trial will be a phase II randomized controlled trial. A total of 66 men with low- or intermediate-grade clinically localized prostate cancer undergoing active surveillance will be randomized to either a 12-week of supervised high-intensity aerobic interval training or usual care. The primary outcome will be peak oxygen consumption (VO2peak) as a measure of physical fitness. The secondary outcomes include tumour-related biomarkers, fear of cancer progression, quality of life, and psychological distress. Exploratory outcomes will include indicators of cancer progression including prostate-specific antigen. Based on this sample size, our study has 80% power with a two-tailed alpha <0.05 to detect a clinically meaningful effect of 3.5 ml/kg/min on our primary outcome of VO2max. This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are at least moderate (i.e., a standardized effect size of d=0.60).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years of age
  • diagnosed with low or favorable intermediate grade localized PCa defined as PSA less than 10, Gleason Score 3+3 or 3+4 with low volume, and digital rectal examination (DRE) of T1C or T2A
  • initiating or continuing active surveillance with no plans for treatment for prostate cancer in the next 6 months (e.g., radical prostatectomy, radiotherapy, or androgen deprivation therapy)
  • screened for medical clearance for exercise testing and participation in vigorous aerobic exercise
  • residing in a commutable area near Edmonton, Alberta
  • willing to commute to the Behavioural Medicine Fitness Centre three times per week to attend a 12-week supervised high-intensity aerobic interval exercise program

Exclusion criteria

  • having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise (e.g., known cardiac disease or uncontrolled hypertension)
  • having contraindications for cardiopulmonary stress and/or physical fitness tests
  • currently participating in a structured, vigorous exercise program.

Treatment and study plan

High-intensity aerobic interval training (HIIT)

Behavioral

A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals

Primary outcomes

  1. Changes of Peak Oxygen Consumption (VO2peak)

    Time frame: At baseline and 12-week (postintervention)

    VO2peak is a measure of cardiopulmonary fitness and a powerful surrogate outcome for cancer-specific and overall survival. VO2peak will be defined as the highest oxygen-uptake value recorded during the test and quantified where participants reach a plateau in oxygen consumption, which will be expressed as relative to body mass (i.e., ml O2·kg-1·min-1).

Secondary outcomes

  1. Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts

    Time frame: At baseline and 12-week (postintervention)

    NKCA significantly contributes to the regulation of tumour suppression in response to exercise and it has been demonstrated to have a diagnostic value in patients with cancer. NK cell activities are assessed using blood analysis as the total number of circulating NK cells and their cytotoxic activity. NK cell counts and NKCA will be measured using the phenotypic markers of NK cells (CD3-CD16+CD56+). NKCA will be expressed as the percentage of target cells killed by a sample of 100,000 peripheral blood mononuclear cells at the effector-to-target ratios of 5:1, 20:1, 40:1, and 100:1.

  2. Changes of Immune-Related Phenotype

    Time frame: At baseline and 12-week (postintervention)

    Immune-related phenotypic markers, including CD3, CD16, CD56, and CD107 (on the frozen) and CD4, CD8, CD20, CD25, CD11, CD45RA, CD45RO, CD16, CD56, CD107 activation (fresh on whole blood), will be assessed using blood samples.

  3. Changes of Prostate-Specific Antigen (PSA)

    Time frame: At baseline, 12-week (postintervention)

    PSA will be assessed using blood samples.

  4. Changes of Complete Blood Count with Differential (CBCD)

    Time frame: At baseline and 12-week (postintervention)

    CBCD, including RBC, WBC, HGB, HCT, PLT, LYMPH, BASO, EOS, MONO, NEUT, will be assessed using blood samples.

  5. Changes of Insulin

    Time frame: At baseline and 12-week (postintervention)

    Fasting insulin levels will be assessed using blood samples.

  6. Changes of Fasting Glucose

    Time frame: At Baseline and 12-week postintervention

    Fasting glucose levels will be assessed using blood samples.

  7. Changes of HbA1c

    Time frame: At Baseline and 12-week postintervention

    HbA1c will be assessed using using blood samples.

  8. Changes of Insulin-like Growth Factor (IGF)-axis

    Time frame: At baseline and 12-week (postintervention)

    IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.

  9. Changes of Pro-Inflammatory Cytokines

    Time frame: At baseline and 12-week (postintervention)

    Pro-inflammatory cytokines, including IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be assessed.

  10. Changes of High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: At Baseline and 12-week postintervention

    hs-CRP will be assessed using blood samples.

  11. Changes of Adiponectin

    Time frame: At Baseline and 12-week postintervention

    Adiponectin will be assessed using blood samples.

  12. Physical Function

    Time frame: At Baseline and 12-week postintervention

    Physical function, consisting of strength, flexibility, and agility components, will be assessed by the Senior's Fitness Test (SFT).

  13. Health-Related Quality of Life

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Health-related quality of life will be assessed using the European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire (EORTC-QLQ) - C30 questionnaire.

  14. Prostate Cancer-Specific Quality of Life

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Prostate cancer-specific quality of life will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire.

  15. Fear of Cancer Progression

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Fear of cancer progression will be assessed using the Fear of Cancer Recurrence Inventory (FCRI) questionnaire.

  16. Cancer Worry

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.

  17. General Anxiety

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.

  18. Prostate Cancer-Specific Anxiety

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Prostate cancer-specific anxiety will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire.

  19. Depression

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.

  20. Perceived Stress

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.

  21. Self-esteem

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.

  22. Fatigue

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.

  23. Physical Activity Level

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Physical activity level, consisting of light-, moderate-, and vigorous aerobic exercise and resistance exercise, will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ).

  24. Exercise Motivation

    Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month

    Exercise motivation, consisting of Theory of Planned Behaviour (TPB) constructs (instrumental and affective attitudes, subjective norms, intention and perceived behavioral control), will be assessed using questionnaire.

  25. Body composition

    Time frame: At baseline and 12-week (postintervention)

    Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance

Acronym: ERASE

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 29, 2017
Registry last updated
Apr 18, 2022

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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