Men with metastatic castrate-resistant prostate cancer can experience an array of treatment-related side effects. Accumulating evidence suggests exercise may alleviate some of these adversities and assist in disease management. However, empirical evidence in advanced prostate cancer patients remains limited. The purpose of this study is to determine whether men with metastatic prostate cancer, who are ineligible for high-intensity exercise, can partake in a home-based, moderate-intensity exercise program and the impact of doing so on quality of life and physical fitness parameters. Thirty men with adenocarcinoma of the prostate and progressive systemic, metastatic disease will be recruited. Clinicians will screen patients against inclusion criteria to determine eligibility. All men enrolled will be prescribed a tailored, home-based, moderate-intensity exercise intervention consisting of aerobic and strengthening components for 12 weeks. Patients will receive supplementary education materials and weekly behavioural change consultations throughout the intervention. The primary outcome will be the feasibility of delivering such an intervention in men with metastatic disease. Secondary endpoints including skeletal events will be monitored for safety, as will the feasibility of patient-reported outcome measures and the sampling time points, generating data pertaining to completion rates and potential effect in future trials. General physical fitness will be assessed during these visits, using timed sit-to-stand testing and a 6-min walking test. Prior to each visit, objective physical activity levels will be captured for 7 days using an accelerometer, to determine the feasibility of this technology and the quality of data obtained. In parallel with the feasibility aspects of the trial, changes compared to baseline will be reported. Direct regular contact will also serve as a feedback loop, should any issues arise. This study has received ethical approval from the Office for Research Ethics Committees Northern Ireland. This study aims to determine the potential utility of a home-based exercise intervention in managing side effects associated with advanced prostate cancer and its treatment. This feasibility trial will inform the design and implementation of a larger randomised control trial to determine the efficacy of moderate aerobic and strengthening exercise as an adjuvant therapy in men with metastatic prostate cancer. Collecting such evidence provides further support for exercise in this paradigm and potential for its inclusion as a low-toxicity therapy in standard cancer care, in the longer term. ClinicalTrials.gov, NCT03658486 Trial sponsor: Queen’s University Belfast (Reference: B18/15). Contact: Dr. Paula Tighe, Research and Enterprise, Queen’s University Belfast. Telephone: 02890 973,296. Email: p.tighe@qub.ac.uk . The sponsor reviewed the protocol and ethical application prior to submission. Protocol issue: Version 1 (18th May 2018). Authors: MB, MM, SJ and GP.

中文翻译：

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晚期前列腺癌的运动：针对患有转移性去势抵抗性前列腺癌的男性的多成分、可行性试验方案 (EXACT)

患有转移性去势抵抗性前列腺癌的男性可能会经历一系列与治疗相关的副作用。越来越多的证据表明，运动可以缓解其中一些逆境并有助于疾病管理。然而，晚期前列腺癌患者的经验证据仍然有限。本研究的目的是确定不适合进行高强度运动的转移性前列腺癌男性是否可以参加家庭中等强度运动计划，以及这样做对生活质量和身体健康的影响参数。将招募 30 名患有前列腺腺癌和进行性全身转移性疾病的男性。临床医生将根据纳入标准对患者进行筛选以确定资格。所有参加的男性都将接受为期 12 周的量身定制的、以家庭为基础的中等强度运动干预，其中包括有氧运动和力量训练。在整个干预过程中，患者将收到补充教育材料和每周的行为改变咨询。主要结果将是对患有转移性疾病的男性进行这种干预的可行性。将监测包括骨骼事件在内的次要终点的安全性，以及患者报告的结果测量和采样时间点的可行性，生成有关完成率和未来试验的潜在影响的数据。在这些访问期间，将使用定时坐站测试和 6 分钟步行测试来评估一般身体健康状况。每次访问之前，将使用加速度计捕获 7 天的客观身体活动水平，以确定该技术的可行性和所获得数据的质量。在试验可行性方面的同时，将报告与基线相比的变化。如果出现任何问题，直接定期联系也将作为反馈循环。这项研究已获得北爱尔兰研究伦理委员会办公室的伦理批准。本研究旨在确定家庭运动干预在管理与晚期前列腺癌及其治疗相关的副作用方面的潜在效用。这项可行性试验将为更大规模的随机对照试验的设计和实施提供信息，以确定适度有氧运动和强化运动作为辅助治疗对转移性前列腺癌男性的疗效。收集此类证据为这种范例中的锻炼提供了进一步的支持，并从长远来看将其作为一种低毒性疗法纳入标准癌症护理中。ClinicalTrials.gov，NCT03658486 试验赞助商：贝尔法斯特女王大学（参考号：B18/15）。联系人：贝尔法斯特女王大学研究与企业部的 Paula Tighe 博士。电话：02890 973,296。电子邮件：p.tighe@qub.ac.uk。申办者在提交前审查了方案和道德应用。协议问题：版本 1（2018 年 5 月 18 日）。作者：MB、MM、SJ 和 GP。