The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 360
- 主要终点
- Time to Progression
研究概览
简要总结
RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.
详细描述
CALGB 70807 is a randomized, phase III clinical trial designed to test this practical, diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS will be randomized either to an intervention of centralized, telephone-based dietary counseling and structured dietary education or to a comparison control condition in which they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease progression, incidence of treatment, and health-related quality of life.
OBJECTIVES:
Primary
- To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.
Secondary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to Progression
时间窗: Up to 2 years
Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).
次要结局
- Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed(Up to 2 years)
- Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24(Up to 2 years)
- Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall(Up to 2 years)