Neoadjuvant Dietary Intervention in Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
研究概览
简要总结
This clinical trial studies the effects of a dietary intervention prior to surgery (neoadjuvant) in patients with intermediate risk prostate cancer. Changing your diet before surgery may help to improve overall health. Information from this study may help researchers better understand the influence of diet on the outcomes of patients with intermediate prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of a neoadjuvant feeding study prior to radical prostatectomy in a racially diverse group of men diagnosed with intermediate risk prostate cancer, defined as the percentage of patients who enter the pre-intervention equilibration period and begin the dietary intervention.
SECONDARY OBJECTIVES:
I. Determine the tolerance of Mediterranean diet as defined by compliance with diet of 70% or greater total calories consumed during study period from the Mediterranean diet.
II. Determine the effects of controlled dietary interventions on metabolic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate that is localized based on prostate magnetic resonance imaging (MRI) and meets National Comprehensive Cancer Network (NCCN) intermediate risk criteria (as follows):
- •Clinical T2b-T2c or lower disease
- •Gleason Grade group 2 or 3 on biopsy
- •Prostate specific antigen (PSA) =< 20 ng/mL
- •Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist
- •Adult men > 30 and < 75 years old (African American or non-Hispanic white)
- •Meet one of the following criteria for overweight or obesity:
- •Body Mass Index (BMI) between 26 and 39
- •Waist circumference >= 40 inches
- •Willingness to exclusively consume all the provided meals
- •Willingness to comply with all study procedures and scheduled visits
- •Reside in the greater Houston/outlying areas and/or willing to travel for study-related visits at MD Anderson
排除标准
- •Major dietary restrictions or food allergies
- •Food aversions or preferences that preclude following a Mediterranean diet, such as unwillingness to eat vegetables, grains, animal products or fish
- •Medical contraindications to the intervention diet as determined by the treating physician
- •Current self-reported smoker or heavy drinker (defined as >14 drinks per week) or current self-reported illicit drug use
- •Prostate cancer that meets NCCN high and very high risk criteria (as follows):
- •pT3a or higher disease
- •Grade group 4 or 5 adenocarcinoma of prostate
- •PSA > 20ng/mL
研究组 & 干预措施
Treatment (dietary intervention, radical prostatectomy)
Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
干预措施: Dietary Intervention (Other)
Treatment (dietary intervention, radical prostatectomy)
Patients participate in the Mediterranean diet for 6 days per week for 4 weeks before undergoing standard of care radical prostatectomy.
干预措施: Radical Prostatectomy (Procedure)
结局指标
主要结局
Feasibility of conducting a controlled feeding study in prostate cancer patients with intermediate risk disease
时间窗: Up to 1 year from site initiation
Feasibility is defined as \>= 25% of patients who enter the equilibration period initiating the dietary intervention.
次要结局
- The effects of controlled dietary interventions on the fecal microbiome(Up to 1 year)
- Examine the safety of controlled dietary interventions in patients with a diagnosis of prostate cancer percentage of severe adverse reactions in patients completing the diet.(Up to 1 year)
- Tolerance of Mediterranean diet(Up to 1 year)
- Determine changes in Cav-1-sphingolipid signature following Mediterranean diet consumption(Up to 1 year)
- Determine changes in Cav-1-sphingolipid signature following dietary intervention compared to a separate cohort with no intervention(Up to 1 year)
- Create a well annotated bank of clinical data and samples, including peri-prostatic fat, for use in future research and analysis(Up to 1 year)
- The effects of controlled dietary interventions on metabolic parameters(Up to 1 year)