The University Hospitals Centre for Health Care Research (UCSF), Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, Copenhagen 2100, Denmark.
BMC Cancer. 2013 Dec 13;13:595. doi: 10.1186/1471-2407-13-595.
Androgen 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/DESIGN: Using 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.
The 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.
ClinicalTrials.gov: NCT01711892.
雄激素剥夺疗法（ADT）是治疗晚期前列腺癌的基石。ADT 会产生广泛报道的肌肉骨骼和心血管不良影响，有必要研究运动是否可能改善治疗效果。“足球俱乐部（FC）前列腺”研究是一项随机试验，比较了足球训练与标准治疗方法对接受 ADT 治疗的前列腺癌男性的身体成分、心血管功能、身体功能参数、葡萄糖耐量、骨健康和患者报告结果的影响。
方法/设计：采用单中心随机对照设计，在哥本哈根大学医院接受 ADT 治疗 6 个月或以上的 80 名经组织学证实的局部晚期或转移性前列腺癌男性将参加这项试验。在基线评估后，符合条件的参与者将被随机分配到足球训练组或接受常规护理的对照组。足球干预将包括 12 周的训练，每周 2-3 次，每次 45-60 分钟，之后将重复评估方案。然后，足球训练将每两周进行一次，持续 20 周，在结束时将重复所有测量，以允许对长期效果进行额外分析。主要终点是通过双能 X 线吸收法扫描评估从基线到 12 周的瘦体重变化。次要终点包括心血管、代谢和身体功能参数的变化，以及骨代谢标志物和患者报告结果的变化。
FC 前列腺试验将评估一种新的足球训练方法对接受 ADT 的晚期前列腺癌男性的一些重要临床健康结果的安全性和有效性。结果可能为治疗前列腺癌的创新社区干预方法铺平道路。
ClinicalTrials.gov：NCT01711892。
