Exercise During Active Surveillance for Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Exercise Group

Supervised high-intensity aerobic interval training (HIIT) during active surveillance

Group Type EXPERIMENTAL

High-intensity aerobic interval training (HIIT)

Intervention Type BEHAVIORAL

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

Usual Care Group

The usual care group will be provided with standard active surveillance medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-intensity aerobic interval training (HIIT)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No