Back to resultsExercise During Active Surveillance for Prostate Cancer (ERASE)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-intensity aerobic interval training (HIIT)
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostate Cancer, Active Surveillance, Exercise, High-Intensity Interval Training, Randomized Controlled Trial
Eligibility Criteria
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.
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise Group
Usual Care Group
Arm Description
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
The usual care group will be provided with standard active surveillance medical care.
Outcomes
Primary Outcome Measures
Changes of Peak Oxygen Consumption (VO2peak)
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 Outcome Measures
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
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.
Changes of Immune-Related Phenotype
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.
Changes of Prostate-Specific Antigen (PSA)
PSA will be assessed using blood samples.
Changes of Complete Blood Count with Differential (CBCD)
CBCD, including RBC, WBC, HGB, HCT, PLT, LYMPH, BASO, EOS, MONO, NEUT, will be assessed using blood samples.
Changes of Insulin
Fasting insulin levels will be assessed using blood samples.
Changes of Fasting Glucose
Fasting glucose levels will be assessed using blood samples.
Changes of HbA1c
HbA1c will be assessed using using blood samples.
Changes of Insulin-like Growth Factor (IGF)-axis
IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.
Changes of Pro-Inflammatory Cytokines
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.
Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
hs-CRP will be assessed using blood samples.
Changes of Adiponectin
Adiponectin will be assessed using blood samples.
Physical Function
Physical function, consisting of strength, flexibility, and agility components, will be assessed by the Senior's Fitness Test (SFT).
Health-Related Quality of Life
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.
Prostate Cancer-Specific Quality of Life
Prostate cancer-specific quality of life will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire.
Fear of Cancer Progression
Fear of cancer progression will be assessed using the Fear of Cancer Recurrence Inventory (FCRI) questionnaire.
Cancer Worry
Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
General Anxiety
General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.
Prostate Cancer-Specific Anxiety
Prostate cancer-specific anxiety will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire.
Depression
Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
Perceived Stress
Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
Self-esteem
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
Fatigue
Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.
Physical Activity Level
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).
Exercise Motivation
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.
Body composition
Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03203460
Brief Title
Exercise During Active Surveillance for Prostate Cancer
Acronym
ERASE
Official Title
A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Active Surveillance, Exercise, High-Intensity Interval Training, Randomized Controlled Trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded to group assignment for the primary outcome of natural killer cell cytotoxic activity and the secondary outcomes of other circulating biomarkers.
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
The usual care group will be provided with standard active surveillance medical care.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity aerobic interval training (HIIT)
Intervention Description
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
Primary Outcome Measure Information:
Title
Changes of Peak Oxygen Consumption (VO2peak)
Description
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).
Time Frame
At baseline and 12-week (postintervention)
Secondary Outcome Measure Information:
Title
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Description
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.
Time Frame
At baseline and 12-week (postintervention)
Title
Changes of Immune-Related Phenotype
Description
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.
Time Frame
At baseline and 12-week (postintervention)
Title
Changes of Prostate-Specific Antigen (PSA)
Description
PSA will be assessed using blood samples.
Time Frame
At baseline, 12-week (postintervention)
Title
Changes of Complete Blood Count with Differential (CBCD)
Description
CBCD, including RBC, WBC, HGB, HCT, PLT, LYMPH, BASO, EOS, MONO, NEUT, will be assessed using blood samples.
Time Frame
At baseline and 12-week (postintervention)
Title
Changes of Insulin
Description
Fasting insulin levels will be assessed using blood samples.
Time Frame
At baseline and 12-week (postintervention)
Title
Changes of Fasting Glucose
Description
Fasting glucose levels will be assessed using blood samples.
Time Frame
At Baseline and 12-week postintervention
Title
Changes of HbA1c
Description
HbA1c will be assessed using using blood samples.
Time Frame
At Baseline and 12-week postintervention
Title
Changes of Insulin-like Growth Factor (IGF)-axis
Description
IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.
Time Frame
At baseline and 12-week (postintervention)
Title
Changes of Pro-Inflammatory Cytokines
Description
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.
Time Frame
At baseline and 12-week (postintervention)
Title
Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
Description
hs-CRP will be assessed using blood samples.
Time Frame
At Baseline and 12-week postintervention
Title
Changes of Adiponectin
Description
Adiponectin will be assessed using blood samples.
Time Frame
At Baseline and 12-week postintervention
Title
Physical Function
Description
Physical function, consisting of strength, flexibility, and agility components, will be assessed by the Senior's Fitness Test (SFT).
Time Frame
At Baseline and 12-week postintervention
Title
Health-Related Quality of Life
Description
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.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Prostate Cancer-Specific Quality of Life
Description
Prostate cancer-specific quality of life will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Fear of Cancer Progression
Description
Fear of cancer progression will be assessed using the Fear of Cancer Recurrence Inventory (FCRI) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Cancer Worry
Description
Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
General Anxiety
Description
General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Prostate Cancer-Specific Anxiety
Description
Prostate cancer-specific anxiety will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Depression
Description
Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Perceived Stress
Description
Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Self-esteem
Description
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Fatigue
Description
Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Physical Activity Level
Description
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).
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Exercise Motivation
Description
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.
Time Frame
At baseline, 12-week (postintervention), 6-month, and 12-month
Title
Body composition
Description
Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.
Time Frame
At baseline and 12-week (postintervention)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry S Courneya, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2H9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34410322
Citation
Kang DW, Fairey AS, Boule NG, Field CJ, Wharton SA, Courneya KS. Effects of Exercise on Cardiorespiratory Fitness and Biochemical Progression in Men With Localized Prostate Cancer Under Active Surveillance: The ERASE Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1487-1495. doi: 10.1001/jamaoncol.2021.3067.
Results Reference
result
PubMed Identifier
35179044
Citation
Kang DW, Fairey AS, Boule NG, Field CJ, Wharton SA, Courneya KS. A Randomized Trial of the Effects of Exercise on Anxiety, Fear of Cancer Progression and Quality of Life in Prostate Cancer Patients on Active Surveillance. J Urol. 2022 Apr;207(4):814-822. doi: 10.1097/JU.0000000000002334. Epub 2022 Feb 17.
Results Reference
result
PubMed Identifier
36175907
Citation
Kang DW, Boule NG, Field CJ, Fairey AS, Courneya KS. Effects of supervised high-intensity interval training on motivational outcomes in men with prostate cancer undergoing active surveillance: results from a randomized controlled trial. Int J Behav Nutr Phys Act. 2022 Sep 29;19(1):126. doi: 10.1186/s12966-022-01365-2.
Results Reference
derived
PubMed Identifier
31278095
Citation
Kang DW, Fairey AS, Boule NG, Field CJ, Courneya KS. Exercise duRing Active Surveillance for prostatE cancer-the ERASE trial: a study protocol of a phase II randomised controlled trial. BMJ Open. 2019 Jul 4;9(7):e026438. doi: 10.1136/bmjopen-2018-026438.
Results Reference
derived
Learn more about this trial
Exercise During Active Surveillance for Prostate Cancer
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