- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203460
Exercise During Active Surveillance for Prostate Cancer (ERASE)
April 8, 2022 updated by: University of Alberta
A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G2H9
- University of Alberta
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Group
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
|
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
|
No Intervention: Usual Care Group
The usual care group will be provided with standard active surveillance medical care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
At baseline and 12-week (postintervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline and 12-week (postintervention)
|
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.
|
At baseline and 12-week (postintervention)
|
Changes of Prostate-Specific Antigen (PSA)
Time Frame: At baseline, 12-week (postintervention)
|
PSA will be assessed using blood samples.
|
At baseline, 12-week (postintervention)
|
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.
|
At baseline and 12-week (postintervention)
|
Changes of Insulin
Time Frame: At baseline and 12-week (postintervention)
|
Fasting insulin levels will be assessed using blood samples.
|
At baseline and 12-week (postintervention)
|
Changes of Fasting Glucose
Time Frame: At Baseline and 12-week postintervention
|
Fasting glucose levels will be assessed using blood samples.
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At Baseline and 12-week postintervention
|
Changes of HbA1c
Time Frame: At Baseline and 12-week postintervention
|
HbA1c will be assessed using using blood samples.
|
At Baseline and 12-week postintervention
|
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.
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At baseline and 12-week (postintervention)
|
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.
|
At baseline and 12-week (postintervention)
|
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.
|
At Baseline and 12-week postintervention
|
Changes of Adiponectin
Time Frame: At Baseline and 12-week postintervention
|
Adiponectin will be assessed using blood samples.
|
At Baseline and 12-week postintervention
|
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).
|
At Baseline and 12-week postintervention
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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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.
|
At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
|
At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
|
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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
|
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).
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At baseline, 12-week (postintervention), 6-month, and 12-month
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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.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Body composition
Time Frame: At baseline and 12-week (postintervention)
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Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.
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At baseline and 12-week (postintervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kerry S Courneya, PhD, University of Alberta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Actual)
May 31, 2020
Study Completion (Actual)
May 31, 2021
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 28, 2017
First Posted (Actual)
June 29, 2017
Study Record Updates
Last Update Posted (Actual)
April 18, 2022
Last Update Submitted That Met QC Criteria
April 8, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREBA.CC-17-0248
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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