Impact of Web-Based Lifestyle Interventions on Prostate Cancer Prognosis

基于网络的生活方式干预对前列腺癌预后的影响

• 批准号: 9982038
• 负责人: Stacey Kenfield
• 金额: --
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9982038
• 关键词: Address; Adjuvant Therapy; Affect; Biological; Biology; Biopsy; California; Cancer Biology; Cancer Etiology; Cancer Patient; Cancer Prognosis; Cessation of life; Clinical; Contralateral; DNA Repair; Data; Diagnosis; Diet; Dietary Factors; Disease; Enrollment; Evidence based intervention; Exercise; FDA approved; Goals; Growth Factor; Indolent; Inflammation; Internet; Intervention; Life Style; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Messenger RNA; Morbidity - disease rate; Neoplasm Metastasis; Nonmetastatic; Normal tissue morphology; Online Systems; Operative Surgical Procedures; Outcome; Oxidative Stress; Pathway interactions; Patients; Pattern; Physical activity; Probability; Prognostic Marker; Prostate; Prostate Cancer therapy; Prostate-Specific Antigen; Prostatectomy; Prostatic Neoplasms; Radical Prostatectomy; Randomized; Randomized Controlled Trials; Recurrence; Reporting; Risk; San Francisco; Signal Pathway; Signal Transduction; Testing; Text Messaging; Time; Tissues; Tumor Biology; Tumor Tissue; United States; Universities; adipokines; angiogenesis; arm; base; cancer diagnosis; cancer recurrence; design; diet and exercise; evidence base; exercise intervention; experience; fitbit; follow up assessment; improved; innovation; insulin signaling; lifestyle factors; lifestyle intervention; mRNA Expression; men; mortality; multidisciplinary; novel; overtreatment; post intervention; pre-clinical; prevent; primary outcome; prognostic; programs; prostate cancer progression; prostate cancer risk; prostate surgery; public health priorities; surgical risk; tailored messaging; treatment arm; treatment as usual; tumor; tumor progression; urinary; usual care arm

PROJECT SUMMARY Prostate cancer is the most commonly diagnosed cancer among men in the United States (US), with more than 220,800 new diagnoses expected in 2015. While a large proportion of new cases appear to have clinically indolent tumors, prostate cancer remains the second-leading cause of cancer death among men in the US. Preventing progression of initially localized prostate cancers to lethal disease is a key priority. Evidence from our group and others suggests that lifestyle factors after prostate cancer diagnosis may prevent non-metastatic prostate cancer from becoming lethal disease. We recently developed an 11-factor score based on lifestyle practices after diagnosis that is strongly associated with reduced risk of prostate cancer death (unpublished). Men with 4-7 and 8-11 points (vs. 0-3) had a 48% (HR= 0.52, 95%CI=0.32, 0.84) and 75% (HR=0.25; 95% CI=0.09, 0.69) lower risk of prostate cancer death, respectively. Based on these compelling data, we developed a lifestyle program delivered via the Internet for prostate cancer patients, with the ultimate goal of improving clinical outcomes in men with prostate cancer by incorporating a lifestyle intervention as adjuvant therapy to standard prostate cancer management. In this proposal, we aim to address the critical question – does access to an Internet-based lifestyle program (designed to increase exercise +/- improve diet quality) impact prostate biology and reduce risk of prostate cancer progression? We propose to conduct a 2-year 3-arm (web-based intervention targeting exercise vs. web-based intervention targeting exercise + diet vs. usual care) randomized controlled trial among 150 prostate cancer patients opting for surgery at the University of California, San Francisco. Men will be enrolled eight weeks before radical prostatectomy and complete follow-up assessments 6 months, 1 year, and 2 years post-surgery. Men assigned to the intervention arms will receive a two-year web- based lifestyle program post-surgery and text messaging tailored to the intervention (i.e., exercise or exercise + diet) and Fitbits. We will examine the effect of exercise vs. exercise + diet vs. usual care on: 1) a validated, FDA- approved prognostic score, Decipher, measured in biopsy (pre-intervention) and prostatectomy (post-initial 8- week intervention period) tissue; 2) mRNA expression of cancer-related pathways in tumor and normal tissue from biopsy and prostatectomy; 3) detectable PSA post-surgery and risk of prostate cancer recurrence at 2- years after radical prostatectomy; and 4) sexual and urinary function at 6 months, 1 year, and 2 years post- surgery. This study will provide critical translational data on the effect of a sustainable Internet-based intervention on prostate tumor biology and clinical outcomes in men with prostate cancer. These data will support the use of lifestyle interventions as adjuvant therapy for prostate cancer. Strengths of this proposal include our novel, evidence-based, intervention; highly relevant preliminary data; innovative prognostic biomarker outcome; and experienced multi-disciplinary team with outstanding track record.

项目摘要 前列腺癌是美国（US）男性中最常诊断的癌症， 预计2015年将有220，800例新诊断。虽然很大一部分新病例似乎在临床上 虽然前列腺癌是惰性肿瘤，但它仍然是美国男性癌症死亡的第二大原因。 预防最初局限性前列腺癌发展为致命疾病是一个关键的优先事项。证据 我们的研究小组和其他研究人员认为，前列腺癌诊断后的生活方式因素可能会阻止非转移性前列腺癌的发生。 防止前列腺癌成为致命疾病我们最近开发了一个基于生活方式的11因素评分 诊断后的实践与前列腺癌死亡风险降低密切相关（未发表）。 4-7分和8-11分（与0-3分相比）的男性有48%（HR= 0.52，95%CI=0.32，0.84）和75%（HR=0.25; 95%CI =0.09， 0.69）降低前列腺癌死亡风险。基于这些令人信服的数据，我们开发了一种生活方式 通过互联网为前列腺癌患者提供的计划，最终目标是改善临床 通过将生活方式干预作为标准治疗的辅助治疗， 前列腺癌的治疗在本提案中，我们的目标是解决关键问题-是否能够获得 基于互联网的生活方式计划（旨在增加运动+/-改善饮食质量）影响前列腺 生物学和降低前列腺癌进展的风险？我们建议进行一项为期两年的三组（网上 针对运动的干预与针对运动+饮食的基于网络的干预与常规护理） 一项在加州大学旧金山分校选择手术的150名前列腺癌患者中进行的对照试验， 弗朗西斯科。男性将在根治性乳房切除术前8周入组，并完成随访评估。 术后6个月、1年和2年。分配到干预武器的人将获得两年的网络- 基于术后生活方式计划和针对干预定制的文本消息（即，锻炼或锻炼+ 饮食）和Fitbit。我们将检查运动与运动+饮食与常规护理对以下方面的影响：1）经验证的FDA- 经批准的预后评分，Decipher，在活检（干预前）和子宫切除术（初始8- 2）肿瘤和正常组织中癌症相关通路的mRNA表达 活检和前列腺切除术; 3）术后可检测的PSA和2- 4岁时前列腺癌复发的风险 根治性尿道切除术后6年; 4）术后6个月、1年和2年的性功能和泌尿功能 手术这项研究将提供关键的翻译数据的影响，可持续的互联网为基础的 干预对前列腺癌患者前列腺肿瘤生物学和临床结局的影响。这些数据将 支持使用生活方式干预作为前列腺癌的辅助治疗。本提案的优点 包括我们新的、基于证据的干预;高度相关的初步数据;创新的预后 生物标志物结果;以及经验丰富的多学科团队，具有出色的跟踪记录。