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

基本信息

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
项目类别：
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

项目摘要

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男性（美国）中最常见的癌症，多于 2015年预计有220,800个新诊断。尽管很大一部分新病例似乎在临床上有在美国男性中，前列腺癌的懒惰肿瘤仍然是癌症死亡的第二个领先原因。防止最初局部的前列腺癌发展为致命疾病是重中之重。来自我们的小组和其他人认为，前列腺癌后的生活方式因素诊断可能会阻止非转移性前列腺癌因成为致命疾病。我们最近根据生活方式开发了11个因子分数诊断后的做法与前列腺癌死亡的风险降低密切相关（未发表）。 4-7和8-11分（vs. 0-3）的男性为48％（HR = 0.52，95％CI = 0.32，0.84）和75％（HR = 0.25; 95％CI = 0.09， 0.69）分别降低前列腺癌死亡的风险。基于这些引人入胜的数据，我们开发了一种生活方式通过互联网提供的前列腺癌患者的计划，其最终目的是改善临床通过将生活方式干预纳入标准的调整疗法，将前列腺癌男性的结果纳入前列腺癌管理。在此提案中，我们旨在解决一个关键问题 - 可以访问基于互联网的生活方式计划（旨在增加运动+/-提高饮食质量）影响前列腺生物学并降低前列腺癌进展的风险？我们建议进行2年的3臂（基于网络）干预针对运动与基于Web的干预措施针对锻炼 +饮食与通常的护理） 150名前列腺癌患者在加利福尼亚大学SAN上接受手术的对照试验弗朗西斯科。男性将在根治性前列腺切除术和完整的随访评估前八周入学手术后6个月，1年和2年。分配给干预武器的男人将获得两年的网络 - 根据干预措施量身定制的手术后的生活方式计划和文本消息（即运动或锻炼 + 饮食）和搭配。我们将研究运动与运动 +饮食与常规护理的效果：1）经过验证的FDA-- 批准的预后评分，破译，在活检（干预前）和前列腺切除术中测量（初始后8-- 每周干预期）组织； 2）肿瘤和正常组织中癌症相关途径的mRNA表达进行活检和前列腺切除术； 3）可检测的PSA手术后和前列腺癌复发的风险在2- 根治性前列腺切除术几年； 4）在6个月，1年和2年之后的性和泌尿功能 - 外科手术。这项研究将提供有关可持续基于Internet的效果的关键翻译数据前列腺癌男性的前列腺肿瘤生物学和临床结局的干预。这些数据将支持使用生活方式干预措施作为前列腺癌的调整疗法。该提议的优势包括我们的小说，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；并经验丰富的多学科团队，具有出色的往绩。