随机试验评估超重和肥胖的早期前列腺癌男性进行主动监测时减肥的作用:前列腺癌积极生活方式研究(PALS)的原理和设计。

Randomized trial evaluating the role of weight loss in overweight and obese men with early stage prostate Cancer on active surveillance: Rationale and design of the Prostate Cancer Active Lifestyle Study (PALS).

机构信息

Fred Hutchinson Cancer Research Center, United States.

Fred Hutchinson Cancer Research Center, United States.

出版信息

Contemp Clin Trials. 2019 Jun;81:34-39. doi: 10.1016/j.cct.2019.04.004. Epub 2019 Apr 16.

Abstract

Active surveillance (AS) is increasingly used to monitor patients with low-risk prostate cancer; however, approximately 50% of AS patients experience disease reclassification requiring definitive treatment and little is known about patient characteristics that modify the risk of reclassification. Obesity may be one of the major contributing factors. The Prostate Cancer Active Lifestyle Study (PALS) is a clinical trial evaluating the impact of weight loss among overweight/obese (Body Mass Index (BMI) ≥ 25 kg/m) men with clinically localized prostate cancer on AS. Two hundred participants will be randomized to either the PALS intervention, a 6-month structured diet and exercise program adapted from the Diabetes Prevention Program followed by 6 months of maintenance, or control (general diet and physical activity guidelines delivered in a single session). The PALS intervention involves one-on-one instruction with a registered dietitian and exercise physiologist to achieve the study goal of loss of 7% of baseline weight. Participation is coordinated so that the 6-month time point coincides with the participants' standard-of-care AS prostate biopsy. Primary outcomes will evaluate the intervention effects on circulating and tissue markers of glucose and insulin regulation, health-related quality of life and pathologic upgrading on follow-up prostate biopsies. Additional analyses will determine whether changes in weight and glucose regulation can be sustained for 6 months after the end of instruction. Findings from this trial may have wide reaching implications for men diagnosed with clinically-localized prostate cancer by providing an active lifestyle-based approach to improve prostate cancer patient outcomes.

摘要

主动监测(AS)越来越多地用于监测低危前列腺癌患者;然而,大约 50%的 AS 患者需要重新分类以进行确定性治疗,而对于改变重新分类风险的患者特征知之甚少。肥胖可能是主要的促成因素之一。前列腺癌积极生活方式研究(PALS)是一项临床试验,评估超重/肥胖(体重指数(BMI)≥25kg/m)男性中体重减轻对主动监测中局限性前列腺癌的影响。200 名参与者将被随机分配到 PALS 干预组或对照组。PALS 干预组为 6 个月的结构化饮食和运动计划,改编自糖尿病预防计划,随后进行 6 个月的维持治疗,对照组为一般饮食和体育活动指南,仅在一次就诊中提供。PALS 干预包括与注册营养师和运动生理学家的一对一指导,以实现研究目标,即基线体重减轻 7%。参与者的参与是协调的,以便 6 个月的时间点与参与者的标准护理 AS 前列腺活检相吻合。主要结局将评估干预对血糖和胰岛素调节的循环和组织标志物、健康相关生活质量以及后续前列腺活检的病理升级的影响。额外的分析将确定体重和葡萄糖调节的变化是否可以在指导结束后持续 6 个月。这项试验的结果可能对通过提供积极的生活方式方法来改善前列腺癌患者结局而诊断为局限性前列腺癌的男性产生广泛的影响。

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