Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months.
研究概览
简要总结
This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI >25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed prostate adenocarcinoma
- •Most recent biopsy positive for prostate cancer
- •Currently on or starting active surveillance
- •Ability to read, write, and understand English
- •BMI >24 kg/m2
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- •Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer
- •Age > 18 years
排除标准
- •Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet
- •Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
- •Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)
- •Loss of >10% of body weight within the previous 6 months
- •Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)
- •If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)
- •Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)
- •Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
研究组 & 干预措施
Arm A
Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.
干预措施: Carbohydrate restricted diet (Other)
Arm A
Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.
干预措施: Non-restricted diet (Other)
Arm A
Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.
干预措施: Phone counseling with dietitian (Other)
Arm B
Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian
干预措施: Carbohydrate restricted diet (Other)
Arm B
Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian
干预措施: Non-restricted diet (Other)
Arm B
Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian
干预措施: Phone counseling with dietitian (Other)
结局指标
主要结局
Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months.
时间窗: 6 months
Proliferative index is measured by Ki67/apoptosis rate
次要结局
- Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.(6 months)
- Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months.(6 months)
- Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.(6 months)
- Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.(6 months)
- Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.(6 months)
- Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog.(6 months)
- Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue.(6 months)
- Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5.(6 months)
研究者
Stephen Freedland
Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surgery
Cedars-Sinai Medical Center