Exercise During Active Surveillance for Prostate Cancer

Prostate Cancer Clinical Trial

— ERASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203460
• Other study ID #: HREBA.CC-17-0248
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• High-intensity aerobic interval training (HIIT)
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Kang DW, Fairey AS, Boulé 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. — View Citation

Kang DW, Fairey AS, Boulé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At baseline and 12-week (postintervention)
Secondary	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.	At baseline and 12-week (postintervention)
Secondary	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.	At baseline and 12-week (postintervention)
Secondary	Changes of Prostate-Specific Antigen (PSA)	PSA will be assessed using blood samples.	At baseline, 12-week (postintervention)
Secondary	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.	At baseline and 12-week (postintervention)
Secondary	Changes of Insulin	Fasting insulin levels will be assessed using blood samples.	At baseline and 12-week (postintervention)
Secondary	Changes of Fasting Glucose	Fasting glucose levels will be assessed using blood samples.	At Baseline and 12-week postintervention
Secondary	Changes of HbA1c	HbA1c will be assessed using using blood samples.	At Baseline and 12-week postintervention
Secondary	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.	At baseline and 12-week (postintervention)
Secondary	Changes of Pro-Inflammatory Cytokines	Pro-inflammatory cytokines, including IFN-?, IL-1ß, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-a, will be assessed.	At baseline and 12-week (postintervention)
Secondary	Changes of High-Sensitivity C-Reactive Protein (hs-CRP)	hs-CRP will be assessed using blood samples.	At Baseline and 12-week postintervention
Secondary	Changes of Adiponectin	Adiponectin will be assessed using blood samples.	At Baseline and 12-week postintervention
Secondary	Physical Function	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
Secondary	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.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	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.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	Fear of Cancer Progression	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
Secondary	Cancer Worry	Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	General Anxiety	General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	Prostate Cancer-Specific Anxiety	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
Secondary	Depression	Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	Perceived Stress	Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	Self-esteem	Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	Fatigue	Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	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).	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	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.	At baseline, 12-week (postintervention), 6-month, and 12-month
Secondary	Body composition	Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.	At baseline and 12-week (postintervention)