Prostate CancerERASENCT03203460
Exercise During Active Surveillance for Prostate Cancer
A study testing High-intensity aerobic interval training (HIIT) in people with Prostate Cancer, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- High-intensity aerobic interval training (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2018to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Prostate Cancer
- Being tested
- High-intensity aerobic interval training (HIIT)
- Keywords
- Prostate Cancer, Active Surveillance, Exercise, High-Intensity Interval Training, Randomized Controlled Trial
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity aerobic interval training (HIIT)Behavioural
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Supervised high-intensity aerobic interval training (HIIT) during active surveillance Receives: Behavioral: High-intensity aerobic interval training (HIIT) |
| Usual Care Group | No intervention | The usual care group will be provided with standard active surveillance medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and 12-week (postintervention)
Secondary outcomes (25)
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.
Measured: At baseline and 12-week (postintervention)
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.
Measured: At baseline and 12-week (postintervention)
Changes of Prostate-Specific Antigen (PSA)
PSA will be assessed using blood samples.
Measured: At baseline, 12-week (postintervention)
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.
Measured: At baseline and 12-week (postintervention)
Changes of Insulin
Fasting insulin levels will be assessed using blood samples.
Measured: At baseline and 12-week (postintervention)
Changes of Fasting Glucose
Fasting glucose levels will be assessed using blood samples.
Measured: At Baseline and 12-week postintervention
Changes of HbA1c
HbA1c will be assessed using using blood samples.
Measured: At Baseline and 12-week postintervention
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.
Measured: At baseline and 12-week (postintervention)
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.
Measured: At baseline and 12-week (postintervention)
Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
hs-CRP will be assessed using blood samples.
Measured: At Baseline and 12-week postintervention
Changes of Adiponectin
Adiponectin will be assessed using blood samples.
Measured: At Baseline and 12-week postintervention
Physical Function
Physical function, consisting of strength, flexibility, and agility components, will be assessed by the Senior's Fitness Test (SFT).
Measured: At Baseline and 12-week postintervention
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.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
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.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Fear of Cancer Progression
Fear of cancer progression will be assessed using the Fear of Cancer Recurrence Inventory (FCRI) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Cancer Worry
Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
General Anxiety
General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate Cancer-Specific Anxiety
Prostate cancer-specific anxiety will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Depression
Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Perceived Stress
Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Self-esteem
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Fatigue
Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
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).
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
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.
Measured: At baseline, 12-week (postintervention), 6-month, and 12-month
Body composition
Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.
Measured: At baseline and 12-week (postintervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jul 2018
- Primary completion31 May 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry S Courneya, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203460
- Sponsor's protocol ID
- HREBA.CC-17-0248
- Acronym
- ERASE
- Status last verified
- Nov 2021
- First submitted
- 20 Jun 2017
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34410322Kang 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.
PubMed 35179044Kang 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.
PubMed 36175907Kang 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.
PubMed 31278095
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
- ClinicalTrials.gov ID
- NCT03203460
- Acronym / sponsor ID
- ERASE / HREBA.CC-17-0248
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Active Surveillance, Exercise, High-Intensity Interval Training, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Behavioral: High-intensity aerobic interval training (HIIT)Supervised high-intensity aerobic interval training (HIIT) during active surveillance |
| Usual Care Group | No intervention | –The usual care group will be provided with standard active surveillance medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity aerobic interval training (HIIT)A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals | Behavioural | Exercise Group |
Primary outcome
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).
25 secondary outcomes
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Time frame: At baseline and 12-week (postintervention)
Changes of Immune-Related Phenotype
Time frame: At baseline and 12-week (postintervention)
Changes of Prostate-Specific Antigen (PSA)
Time frame: At baseline, 12-week (postintervention)
Changes of Complete Blood Count with Differential (CBCD)
Time frame: At baseline and 12-week (postintervention)
Changes of Insulin
Time frame: At baseline and 12-week (postintervention)
Changes of Fasting Glucose
Time frame: At Baseline and 12-week postintervention
Changes of HbA1c
Time frame: At Baseline and 12-week postintervention
Changes of Insulin-like Growth Factor (IGF)-axis
Time frame: At baseline and 12-week (postintervention)
Changes of Pro-Inflammatory Cytokines
Time frame: At baseline and 12-week (postintervention)
Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: At Baseline and 12-week postintervention
Changes of Adiponectin
Time frame: At Baseline and 12-week postintervention
Physical Function
Time frame: At Baseline and 12-week postintervention
Health-Related Quality of Life
Time frame: 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
Fear of Cancer Progression
Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month
Cancer Worry
Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month
General Anxiety
Time frame: 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
Depression
Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month
Perceived Stress
Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month
Self-esteem
Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month
Fatigue
Time frame: 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
Exercise Motivation
Time frame: At baseline, 12-week (postintervention), 6-month, and 12-month
Body composition
Time frame: At baseline and 12-week (postintervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Results publication: PubMed 34410322Kang 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 publication: PubMed 35179044Kang 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.
- Derived from this study: PubMed 36175907Kang 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.
- Derived from this study: PubMed 31278095Kang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry S Courneya, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity aerobic interval training (HIIT) in people with Prostate Cancer, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Peak Oxygen Consumption (VO2peak) (time frame: At baseline and 12-week (postintervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03203460, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.