Impact of Exercise on Prognostic Biomarkers Related to Prostate Cancer

Study Overview
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Brief Summary
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The goal of this study is to demonstrate the impact of a home based exercise program versus wait-list control to modulate circulating prognostic biomarkers in men with prostate cancer under active surveillance.

Detailed Description
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Prostate cancer (PCa) is the most common non-skin cancer effecting American males. Several reports suggest that physical activity after cancer diagnosis is associated with better cancer- specific and overall survival in individuals diagnosed with PCa. There is a growing body of evidence for lifestyle interventions that aim to promote physical activity as having the potential to counter some of the adverse effects of cancer treatments, disease progression and other health outcomes. Exercise performed 2-3 times a week has been shown to improve physical fitness, functional performance, and quality of life in men with PCa; however, few men with PCa exercise regularly and do not meet national physical activity guidelines. A potential explanation on the lack of exercise in men with PCa is the absence of a structured, home-based, exercise program. While studies have shown positive effects of exercise in men with PCa, little is known about how physical activity effects tumor physiology in men with PCa. The primary objective of this pilot study is to gather preliminary data regarding the impact of a novel, home-based exercise program on PCa biomarkers associated with recurrence and metastasis of PCa in men under active surveillance.

Official Title
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Impact of a Home-based Exercise Program on Prognostic Biomarkers in Men With Prostate Cancer

Conditions
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Prostatic Neoplasm

Intervention / Treatment
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* Other: Home-Based Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 40 or older Ambulating male Diagnosed with low grade prostate cancer Subjects willing and able to provide consent to participating in the study Exclusion Criteria prostatectomy severe cardiac disease (New York Heart Association class III or greater) angina severe osteoporosis uncontrolled hypertension (blood pressure > 160/95mm Hg) uncontrolled sinus tachycardia (> 120 beats per minute) uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is designed randomized controlled, 2 arm parallel group pilot study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-Based Exercise Program<br>Participants will complete a prescribed home-based exercise program and will follow up with research staff at the UT Health San Antonio School of Nursing. | Other: Home-Based Exercise Program<br>* The intervention will include a combination of both aerobic and body-weight based exercises. The aerobic portion of the intervention will include 5 days of light to moderate intensity walking for 30 mins. Intensity will be set at 40-60% of the individual's heart rate reserve. The body-weight based exercises will be done 3 times a week and will consist of 3 sets of 15 reps of bodyweight squats, incline push-ups, and hip thrusts. If these exercises cannot be performed, lower intensity exercises such as sit-to-stand, wall push up and pelvic tilt can be replaced. Individuals in this group will be given a pocket guide with instructions on how to safely perform the exercises and document their completion.<br>* Other names: Exercise Group;|
| No Intervention: Waitlist-Control Group<br>Participants assigned to this group will be asked to maintain normal activity and visit the UT Health San Antonio School of Nursing for research appointments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in concentration of circulating Prognostic Biomarkers | Analyze concentrations of Prostate-specific antigen (PSA), Prostate-specific membrane antigen (PSMA), Early prostate cancer antigen (EPCA), Urokinase plasminogen activator (uPA), and Urokinase plasminogen activator receptor (uPAR) in serum collected at each visit with research staff. | Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Biomarker Index | Analyze a novel salivary biomarker for fatigue: Measurement of the salivary biomarker, the Fatigue Biomarker Index, will be measuring the concentration of each of two peptides, GGHPPPP (SEQ ID NO:1) and ESPSLIA (SEQ ID NO:2), in a saliva sample taken from the subject then calculating the ratio of the concentration of GGHPPPP (SEQ ID NO:1) to the concentration of ESPSLIA (SEQ ID NO:2) measured according to the equation: Fatigue biomarker index (FBI)=[GGHPPPP]/[ESPSLIA] | Baseline Visit, Week 12 visit, Week 18 visit and Week 24 visit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Biomarkers, Exercise