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
- 180
- 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
- •Preregistration Eligibility:
- •Histologic Documentation:
- •The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility.
- •However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study.
- •Eligible patients must meet all of the following criteria:
- •Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration
- •< 25% of biopsy tissue cores positive for cancer
- •≤ 50% of any one biopsy tissue core positive for cancer
- •Clinical stage ≤ T2a
- •Patients who have prostate cancer with distant metastases are not eligible
- •NOTE: If a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen. However, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study. If prostate cancer is not detected in the biopsy specimen, the patient is not eligible.
- •Prior Treatment: Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e. cryosurgery or high-intensity focused ultrasound) or androgen deprivation therapy are not eligible.
- •Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible.
- •Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone.
- •Life expectancy of at least 3 years
- •Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible.
- •Patients receiving treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) within 90 days prior to preregistration are not eligible. Treatment with these agents during the protocol intervention is not permitted.
- •Patients who are currently taking coumadin are not eligible.
- •Participants will be men aged 50 to 80 years.
- •For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) =
- •Required Initial Laboratory Values:
- •Serum PSA < 10 ng/mL
- •NOTE: Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors.
- •Registration Eligibility:
- •Successful completion of three 24-hour dietary recalls during the run-in period.
- •Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.
排除标准
- 未提供
研究组 & 干预措施
Arm A - MEAL Program Intervention
Patients will receive dietary education and telephone counseling sessions over 24 months.
干预措施: dietary education and counseling (Other)
Arm B - Prostate Cancer Foundation Booklet
Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.
干预措施: prostate cancer foundation booklet (Other)
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)