Exercise During Active Surveillance for Prostate Cancer

NCT03203460 | Completed

• 1 other identifier: HREBA.CC-17-0248
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Active Surveillance; Exercise; High-Intensity Interval Training; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts

  At baseline and 12-week (postintervention)

• Changes of Immune-Related Phenotype

  At baseline and 12-week (postintervention)

• Changes of Prostate-Specific Antigen (PSA)

  At baseline, 12-week (postintervention)

• Changes of Complete Blood Count with Differential (CBCD)

  At baseline and 12-week (postintervention)

• Changes of Insulin

  At baseline and 12-week (postintervention)

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

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.

Interventions

High-intensity aerobic interval training (HIIT) BEHAVIORAL

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

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2H9, Canada

Location

Related Publications (4)

• 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.

  PMID: 34410322 RESULT

• 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.

  PMID: 35179044 RESULT

• 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.

  PMID: 36175907 DERIVED

• 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.

  PMID: 31278095 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Officials

• Kerry S Courneya, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 29, 2017
• Study Start: July 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2021
• Last Updated: April 18, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)