Abstract
BackgroundProstate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may thus experience significant morbidity due to disease progression and treatment toxicity. In order to address some of these problems exercise has been suggested and previously studies have shown improvements of disease specific quality of life and a reduction in treatment-related toxicity. Cohort studies with long term follow up have suggested that physical activity is associated with improved survival in prostate cancer patients. Previously one randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of community-based football for men diagnosed with prostate cancer.MethodsUsing a randomised controlled parallel group, multicenter, superiority trial design, two hundred prostate cancer patients will be recruited and randomised (1:1) to either community-based football one hour twice weekly or to a control group. The intervention period will be six months. The primary outcome is quality of life assessed after 12 weeks based on the change from baseline in the Functional Assessment of Cancer Therapy–Prostate questionnaire. Secondary outcomes are change from baseline to six months in quality of life, lean body mass, fat mass, whole body and regional bone markers, as well as physical activity and functional capacity at 12 weeks and six months. Safety outcome variables will be falls resulting in seeking medical assessment and fractures during the six-month period.DiscussionFootball is viewed as a case for non-professional, supervised community-based team sport for promoting long-term physical activity in men diagnosed with prostate cancer. This randomised trial will provide data on effectiveness and safety for men with prostate cancer when football training is delivered in local football clubs.Trial registrationClinicaltrials.gov identifier: NCT02430792
Highlights
Prostate cancer is the most common non-cutaneous malignancy in men
Treatment of Prostate cancer (PCa) is often associated with side effects and as the patients are likely to survive many years following diagnosis and primary treatment, quality of life (QoL) is of growing interest
A twosided significance level of 5 % and power of 80 % were chosen; The standard deviation is based on a previous exercise trial [30] but increased slightly as FC Prostate Community Trial (FCPC) participants will be more heterogeneous than the participants in that trial
Summary
Prostate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may experience significant morbidity due to disease progression and treatment toxicity. One randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of communitybased football for men diagnosed with prostate cancer. PCa patients managed with hormonal therapy face an elevated risk of becoming overweight and for developing metabolic syndrome, type 2 diabetes and cardiovascular disease [2], which regular physical activity may counteract Despite this fewer than half of men living with PCa follow the official physical activity guidelines [3]. Cohort studies examining the relationship between physical activity and disease progression and survival in men with PCa have shown that vigorous activity is associated with better outcomes [5,6,7]
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