Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jul 4;9(7):e026438.
doi: 10.1136/bmjopen-2018-026438.

Exercise duRing Active Surveillance for prostatE cancer-the ERASE trial: a study protocol of a phase II randomised controlled trial

Dong-Woo Kang  1 , Adrian S Fairey  2 , Normand G Boulé  1 , Catherine J Field  3 , Kerry S Courneya  1
Affiliations

Exercise duRing Active Surveillance for prostatE cancer-the ERASE trial: a study protocol of a phase II randomised controlled trial

Dong-Woo Kang et al. BMJ Open. .

Abstract

Introduction: Active surveillance (AS) is the preferred primary treatment strategy for men with low-risk clinically localised prostate cancer (PCa); however, the majority of these men still receive radical treatment within 10 years due to disease progression and/or fear of cancer progression. Interventions designed to suppress tumour growth, mitigate fear of cancer progression and precondition men for impending radical treatments are an unmet clinical need. Exercise has been shown to delay the progression of prostate tumours in animal models, improve physical and functional health and manage psychological outcomes in cancer patients; however, these outcomes have not been demonstrated in PCa patients undergoing AS.

Methods and analysis: This phase II randomised controlled trial will randomise 66 men undergoing AS to either an exercise group or a usual care group. The exercise group will perform a 12-week, supervised, high-intensity interval training programme, consisting of 3 sessions/week for 28-40 min/session. The primary outcome will be cardiorespiratory fitness. Secondary outcomes will include immunosurveillance and cancer-related biomarkers, psychosocial outcomes including fear of cancer progression and quality of life and physical function. Exploratory outcomes will include clinical indicators of disease progression. The trial has 80% power to detect a significant between-group difference in VO2peak of 3.5 mL/kg/min with a two-tailed alpha level <0.05 and a 10% dropout rate.

Ethics and dissemination: The study has received full ethical approval from the Health Research Ethics Board of Alberta - Cancer Committee (Protocol Number: HREBA.CC-17-0248). The findings of the study will be disseminated through public and scientific channels.

Trial registration number: NCT03203460; Pre-results.

Keywords: active surveillance; exercise; high-intensity interval training; prostate cancer.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Proposed effects of exercise during active surveillance in prostate cancer patients.
Figure 2
Figure 2
Proposed patient flow diagram of the ERASE Trial.
Figure 3
Figure 3
High-intensity interval training programme in the ERASE Trial.
See this image and copyright information in PMC

References

    1. Heidenreich A, Bellmunt J, Bolla M, et al. . EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol 2011;59:61–71. 10.1016/j.eururo.2010.10.039 - DOI - PubMed
    1. Talcott JA, Rieker P, Clark JA, et al. . Patient-reported symptoms after primary therapy for early prostate cancer: results of a prospective cohort study. J Clin Oncol 1998;16:275–83. 10.1200/JCO.1998.16.1.275 - DOI - PubMed
    1. Donovan JL, Hamdy FC, Lane JA, et al. . Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med Overseas Ed 2016;375:1425–37. 10.1056/NEJMoa1606221 - DOI - PMC - PubMed
    1. Chen RC, Basak R, Meyer AM, et al. . Association between choice of radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance and patient-reported quality of life among men with localized prostate cancer. JAMA 2017;317:1141–50. 10.1001/jama.2017.1652 - DOI - PMC - PubMed
    1. Cooperberg MR, Carroll PR, Klotz L. Active surveillance for prostate cancer: progress and promise. J Clin Oncol 2011;29:3669–76. 10.1200/JCO.2011.34.9738 - DOI - PubMed

Publication types

Associated data