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.

项目概要前列腺癌是美国 (US) 男性中最常诊断出的癌症，超过 2015 年预计将有 220,800 例新诊断。虽然大部分新病例似乎有临床症状作为惰性肿瘤，前列腺癌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进展为致命疾病是一个关键优先事项。我们的小组和其他人认为前列腺癌诊断后的生活方式因素可能会预防非转移性癌症我们最近根据生活方式制定了 11 因素评分。诊断后的实践与降低前列腺癌死亡风险密切相关（未发表）。 4-7 分和 8-11 分（相对于 0-3 分）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，分别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辅助治疗达到标准，男性前列腺癌的结果在这项提案中，我们旨在解决一个关键问题——是否能够获得治疗。基于互联网的生活方式计划（旨在增加运动+/-改善饮食质量）影响前列腺生物学并降低前列腺癌进展的风险？我们建议进行为期 2 年的 3 组（基于网络）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）随机加州大学圣何塞分校对 150 名选择手术的前列腺癌患者进行了对照试验弗朗西斯科将在根治性前列腺切除术前八周入组并完成后续评估。手术后 6 个月、1 年和 2 年，分配到干预组的男性将接受为期两年的网络治疗。基于生活方式的术后计划和针对干预措施量身定制的短信（即锻炼或锻炼+ 饮食）和 Fitbits，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）经过验证的 FDA- 批准的预后评分，Decipher，在活检（干预前）和前列腺切除术（初始后 8- 2）肿瘤和正常组织中癌症相关通路的mRNA表达来自活检和前列腺切除术；3) 可检测的术后 PSA 和前列腺癌复发的风险 2- 根治性前列腺切除术后数年；4) 术后 6 个月、1 年和 2 年的性功能和泌尿功能这项研究将为可持续的基于互联网的效果提供关键的转化数据。这些数据将影响前列腺癌男性的肿瘤生物学和临床结果。支持使用生活方式干预作为前列腺癌的辅助治疗。包括我们新颖的、基于证据的干预措施；生物标志物结果；经验丰富的多学科团队，拥有出色的业绩记录。