Abstract
BackgroundAndrogen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer. Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted. The ‘Football Club (FC) Prostate’ study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition, cardiovascular function, physical function parameters, glucose tolerance, bone health, and patient-reported outcomes in men undergoing ADT for prostate cancer.Methods/DesignUsing a single-center randomized controlled design, 80 men with histologically confirmed locally advanced or disseminated prostate cancer undergoing ADT for 6 months or more at The Copenhagen University Hospital will be enrolled on this trial. After baseline assessments eligible participants will be randomly assigned to a soccer training group or a control group receiving usual care. The soccer intervention will consist of 12 weeks of training 2–3 times/week for 45–60 min after which the assessment protocol will be repeated. Soccer training will then continue bi-weekly for an additional 20 weeks at the end of which all measures will be repeated to allow for additional analyses of long-term effects. The primary endpoint is changes in lean body mass from baseline to 12 weeks assessed by dual X-ray absorptiometry scan. Secondary endpoints include changes of cardiovascular, metabolic, and physical function parameters, as well as markers of bone metabolism and patient-reported outcomes.DiscussionThe FC Prostate trial will assess the safety and efficacy of a novel soccer-training approach to cancer rehabilitation on a number of clinically important health outcomes in men with advanced prostate cancer during ADT. The results may pave the way for innovative, community-based interventions in the approach to treating prostate cancer.Trial registrationClinicalTrials.gov: NCT01711892
Highlights
Androgen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer
While ADT contributes to improved life expectancy, it is associated with significant adverse effects, including loss of lean body mass (LBM), decreased bone mineral density (BMD), poor functional performance, increased fat percentage, insulin resistance, and increased risk of fractures [6,7,8,9,10]
The purpose of the present study is to investigate 1) the effects of 12 weeks of recreational soccer on body composition, fitness, cardiac structure and function, peripheral vascular function, blood pressure, physical function parameters, postural balance, muscle strength, glucose tolerance, insulin sensitivity, and markers of inflammation and bone metabolism and 2) whether potential physiological and patient-reported effects of the 12 week soccer training intervention can be maintained or improved further with an additional 20 weeks training at a reduced training volume
Summary
Androgen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer. The ‘Football Club (FC) Prostate’ study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition, cardiovascular function, physical function parameters, glucose tolerance, bone health, and patient-reported outcomes in men undergoing ADT for prostate cancer. The 15 year relative survival rate exceeds 90% for all PCa stages combined and there has been a steady increase in the number of PCa survivors [5], partly attributable to the greater anti-neoplastic efficacy of ADT and radiotherapy in combination. The combination of ADT-induced adverse effects and subsequent changes in health behavior, i.e., physical inactivity and deconditioning, may predispose PCa patients to serious morbidity, including elevated risk of cardiovascular and metabolic disorders, leading to increased mortality [11,12].
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