PALS: Prostate Cancer Active Lifestyle Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
研究概览
简要总结
This randomized phase III trial studies a diet and exercise program based on the Diabetes Prevention Program to promote weight loss and improve health in men with low-risk or low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that promotes weight loss may influence prostate health. A combined diet and exercise program that is based on the Diabetes Prevention Program may affect markers (or "biomarkers") of prostate cancer progression. Gathering this information may help doctors understand how obesity affects prostate cancer progression and may help lead to a program that can reduce the risk of prostate cancer progression.
详细描述
PRIMARY OBJECTIVES:
I. To test whether the Diabetes Prevention Program (DPP) lifestyle intervention (versus [vs.] control) improves serum fasting glucose.
II. To test whether the DPP lifestyle intervention (vs. control) improves serum biomarkers of glucose regulation (insulin, C-peptide, insulin-like growth factor-1 [IGF-1], IGF binding protein 3 [IGF-BP3] and adiponectin).
III. To test whether the DPP lifestyle intervention decreases the levels of insulin receptor or insulin-like growth factor-1 receptor (IGF-1R) in prostate cancer (PCa) tissue epithelium on follow-up prostate biopsy.
IV. To test whether PCa patients randomized to the DPP lifestyle intervention sustain the lifestyle changes for at least 6 months after the end of the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate, clinically localized, low or low-intermediate risk disease (T1C/T2a, Gleason =< 7 [3+4], prostate-specific antigen [PSA] < 20)
- •Primary treatment is active surveillance (AS) with planned annual surveillance biopsies
- •Body mass index (BMI) >= 25 kg/m^2; and
- •Physically able to undertake a diet and exercise program
排除标准
- •Current, recent (< 1 year), or planning to join a weight loss program or take appetite suppressants
- •Steroid hormone use (antiandrogen therapy [ADT]) within the past 12 months
- •Significant cardiovascular disease precluding an exercise program, including recent (within 6 months) myocardial infarction or stroke, pulmonary edema, myocarditis, pericarditis, unstable angina, pulmonary embolism/deep venous thrombosis (PE/DVT), uncontrolled hypertension (systolic blood pressure [SBP] > 200; diastolic blood pressure [DBP] > 110), uncontrolled arrhythmia, heart failure; or
- •Insulin dependent diabetes mellitus (DM) and/or metformin use
- •Doctor of medicine (MD) confirmed cognitive impairment
- •Current alcohol or narcotic abuse
结局指标
主要结局
Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
时间窗: Baseline to 6 months
Mean and standard deviation of change from baseline.
Change From Baseline in Fasting Glucose at 6 Months
时间窗: Baseline to 6 months
Mean and standard deviation of change from baseline.
Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells
时间窗: Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization)
Mean and standard deviation of change from baseline.
Weight at 12 Months
时间窗: 12 months (6 months after active intervention)
Mean and standard deviation of weight at 12 months
Change From Baseline in Fasting Insulin at 6 Months
时间窗: Baseline to 6 months
Mean and standard deviation of change from baseline.
次要结局
- Health Related Quality of Life (HRQOL) at 6 Months(6 months)
研究者
Jonathan Wright
Professor
Fred Hutchinson Cancer Center