A randomized controlled trial of a home-based exercise program on prognostic biomarkers in men with prostate cancer: A study protocol.

BACKGROUND: Herein, we propose a novel RCT study to collect preliminary data on the impact of a 24-week home-based exercise program that can improve prognosis, physical function, and quality of life (QoL) in men with prostate cancer (PCa). This study will provide data on the feasibility of conducting a home-based exercise study and pilot data on the impact of exercise on circulating concentrations of biomarkers reported in the literature to be beneficial for the prognostication of PCa.

METHODS/DESIGN: Thirty male patients, clinically-diagnosed with prostate cancer under active surveillance, will be recruited to participate in a 2-arm, 24-week home-based program . Random allocation to each arm - intervention, and control - will be performed in a 1:1 ratio. Participants assigned to the intervention group will perform 30 min of light-to-moderate intensity walking five days a week (40-60% heart rate reserve) and three sets of 15 repetitions of light callisthenic exercises (bodyweight squats, incline push-ups, and hip thrusts) 3 days a week. Participants randomized to the control group will maintain normal activity throughout the 24 weeks. Four visits occurring at baseline, 12-, 18-, and 24-weeks will be used to assess QoL, body composition, prognostic biomarker concentrations, and overall physical function. Primary endpoints include significant changes in prognostic biomarkers. Secondary endpoints include changes in quality of life, physical function and body composition.

DISCUSSION: This study should demonstrate preliminary evidence that a home-based exercise intervention can impact biomarkers of progression while improving quality of life, physical function and body composition. Results from this study have the potential to promote health and wellness while minimizing cancer progression in men with PCa.