Clinical trial NCT03203460: Exercise During Active Surveillance for Prostate Cancer
Official title: A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Active Surveillance
Exercise
High-Intensity Interval Training
Randomized Controlled Trial
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of Peak Oxygen Consumption (VO2peak)
timeFrame: At baseline and 12-week (postintervention)
Secondary outcomes:
measure: Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
timeFrame: At baseline and 12-week (postintervention)
measure: Changes of Immune-Related Phenotype
timeFrame: At baseline and 12-week (postintervention)
measure: Changes of Prostate-Specific Antigen (PSA)
timeFrame: At baseline, 12-week (postintervention)
measure: Changes of Complete Blood Count with Differential (CBCD)
timeFrame: At baseline and 12-week (postintervention)
measure: Changes of Insulin
timeFrame: At baseline and 12-week (postintervention)
measure: Changes of Fasting Glucose
timeFrame: At Baseline and 12-week postintervention
measure: Changes of HbA1c
timeFrame: At Baseline and 12-week postintervention
measure: Changes of Insulin-like Growth Factor (IGF)-axis
timeFrame: At baseline and 12-week (postintervention)
measure: Changes of Pro-Inflammatory Cytokines
timeFrame: At baseline and 12-week (postintervention)
measure: Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
timeFrame: At Baseline and 12-week postintervention
measure: Changes of Adiponectin
timeFrame: At Baseline and 12-week postintervention
measure: Physical Function
timeFrame: At Baseline and 12-week postintervention
measure: Health-Related Quality of Life
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Prostate Cancer-Specific Quality of Life
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Fear of Cancer Progression
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Cancer Worry
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: General Anxiety
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Prostate Cancer-Specific Anxiety
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Depression
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Perceived Stress
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Self-esteem
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Fatigue
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Physical Activity Level
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Exercise Motivation
timeFrame: At baseline, 12-week (postintervention), 6-month, and 12-month
measure: Body composition
timeFrame: At baseline and 12-week (postintervention)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Kerry S Courneya, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.