Exercise During Active Surveillance for Prostate Cancer

N/ACompletedNCT03203460

University of Alberta52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Prostate Cancer

Interventions

High-intensity aerobic interval training (HIIT)BEHAVIORAL

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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.

Time frame: 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.

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

Changes of Prostate-Specific Antigen (PSA)

PSA will be assessed using blood samples.

Time frame: 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.

Data from ClinicalTrials.gov

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

Changes of Insulin

Fasting insulin levels will be assessed using blood samples.

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

Changes of Fasting Glucose

Fasting glucose levels will be assessed using blood samples.

Time frame: At Baseline and 12-week postintervention

Changes of HbA1c

HbA1c will be assessed using using blood samples.

Time frame: 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.

Time frame: 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.

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

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

hs-CRP will be assessed using blood samples.

Time frame: At Baseline and 12-week postintervention

Changes of Adiponectin

Adiponectin will be assessed using blood samples.

Time frame: 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).

Time frame: 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.