Randomized Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer:

运动疗法对局限性前列腺癌进展标志物的随机试验：

基本信息

批准号：
10705201
负责人：
Paul Christopher Boutros
金额：
$ 67.97万
依托单位：
SLOAN-KETTERING INST CAN RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-15 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10705201
关键词：
2 arm randomized control trial Acute Architecture Behavioral Biopsy Biopsy Specimen Cessation of life Clinic Clinical Confidence Intervals Data Diagnosis Diagnostic Exercise Exercise Therapy Freezing Future Genomic Instability Grant Histology Home Hypoxia Image Incidence Intervention Investigation Local Therapy Localized Disease Magnetic Resonance Imaging Malignant neoplasm of prostate Molecular Monitor Nature Neoplasm Metastasis Noninfiltrating Intraductal Carcinoma Observational Study Operative Surgical Procedures Outcome PSA screening Pathologic Pathologist Patient Care Patient Self-Report Patients Phase II/III Trial Physical activity Quality of life Radiology Specialty Random Allocation Randomized Randomized, Controlled Trials Research Safety Sample Size Sampling Screening Result Structure Symptoms Telemedicine Testing Therapeutic Intervention Time Toxic effect Translating Untranslated RNA Walking Width arm clinical risk conventional therapy cost exercise capacity genome sequencing genome-wide health related quality of life high risk improved men mouse model novel overtreatment post intervention preclinical study prevent primary endpoint programs progression marker prospective prostate biopsy prostate cancer model prostate cancer progression prostate cancer risk randomized trial response serum PSA standard of care transcriptome sequencing treadmill treatment as usual trial design tumor progression whole genome

项目摘要

Abstract Widespread use of serum prostate-specific antigen (PSA) screening results in 50% of new cases of prostate cancer being diagnosed with low-grade localized disease. Standard of care for these cases is to defer immediate treatment in favor of active surveillance (AS), a low-toxicity management which entails close monitoring with PSA tests, repeat prostate biopsies and multi-parametric MRI (mpMRI). Around 30% of men on AS progress or electively undergo definitive treatment within two years of diagnosis. Efficacious low-cost, low-toxicity strategies to limit exit from AS are needed to reduce over-treatment and improve health-related quality of life (QOL). Accordingly, in this proposal we will test whether and how exercise alters prostate cancer molecular landscape. Using a two-arm RCT design, 122 men initiating AS (e.g., inactive, diagnostic biopsy <6 months) will be randomly allocated (1:1 ratio) to exercise therapy intervention (n=61) or usual care (plus general physical activity advice; n=61) for 12 months. Exercise therapy will consist of home-based, treadmill walking five days each week at 65-75% of their personal baseline exercise capacity. All sessions will be implemented using TeleMed-X, a novel telemedicine platform pioneered in our program. Our central hypothesis is that exercise therapy will reduce the number of nimbosus features to collectively inhibit clinical progression. This central hypothesis is tested in three distinct, but complementary aims: Aim 1. Determine effects of exercise therapy on molecular nimbosus hallmarks; Aim 2. Determine effects on the radiologic and pathologic nimbosus hallmarks; and Aim 3. Delineate the precision of estimating rates of clinical progression at 18 months.

抽象的血清前列腺特异性抗原 (PSA) 筛查的广泛使用导致 50% 的新前列腺病例癌症被诊断为低度局部疾病。这些病例的护理标准是推迟立即有利于主动监测（AS）的治疗，这是一种低毒性管理，需要密切监测 PSA 测试、重复前列腺活检和多参数 MRI (mpMRI)。大约 30% 的男性 AS 进展或诊断后两年内选择性接受明确治疗。有效的低成本、低毒性策略需要限制退出 AS，以减少过度治疗并改善与健康相关的生活质量 (QOL)。因此，在本提案中，我们将测试运动是否以及如何改变前列腺癌分子景观。使用双臂 RCT 设计，122 名开始 AS 的男性（例如，不活动、诊断性活检 <6 个月）将被随机分配（1:1 比例）至运动治疗干预（n=61）或常规护理（加上一般身体保健）活动建议； n=61) 12 个月。运动疗法包括在家跑步机上行走五天每周进行个人基线运动能力的 65-75%。所有会话将使用 TeleMed-X，我们项目中首创的新型远程医疗平台。我们的中心假设是锻炼治疗将减少雨云特征的数量，从而共同抑制临床进展。这个中央假设通过三个不同但互补的目标进行检验：目标 1. 确定运动疗法对分子雨云特征；目标 2. 确定对放射学和病理学 Nimbosus 标志的影响；目标 3. 描述 18 个月时临床进展率估计的精确度。