A Phase II Randomized, Open-Label, Two-Arm Study of a Low Omega-6, High Omega-3 Fat Diet Combined With Fish Oil vs. a Control Group in Men on Active Surveillance for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Ki-67 index
研究概览
简要总结
This randomized phase II trial will evaluate if a low omega-6, high omega-3 fat diet combined with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.
详细描述
PRIMARY OBJECTIVES:
I. Determine if a 1-year low omega-6, high omega-3 fat diet combined with fish oil results in decreased prostate cancer Ki-67 index as compared to a control group in men on active surveillance.
SECONDARY OBJECTIVES:
I. Evaluate the effect of a low-fat (LF)/fish oil (FO) intervention on prostate biopsy tissue markers of progression, prostate biopsy pathologic features (Gleason grade, tumor volume ), prostate-specific antigen (PSA), and long-term clinical outcomes (clinical progression, prostate cancer therapies).
II. Evaluate potential surrogate biomarkers of proliferation (red blood cell [RBC] membrane fatty acid analyses, ex-vivo bioassay).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients sign the informed consent
- •Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate
- •Patient elects to undergo active surveillance
- •Clinical stage T2c or less
- •Gleason grade 3+4 or less
- •PSA < 25
- •Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
- •Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study
- •If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study
排除标准
- •Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer
- •Patient has taken finasteride or dutasteride during the prior year
- •Patient has taken fish oil during the prior 3 months
- •Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
- •Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year
- •Patient has allergy to fish
研究组 & 干预措施
Arm II (fish oil)
Patients receive dietary counseling with research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low omega-6, high omega-3 fat diet combined with fish oil. Patients also receive 4 fish oil capsules per day PO for 1 year.
干预措施: omega-3 fatty acid (Dietary Supplement)
Arm II (fish oil)
Patients receive dietary counseling with research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low omega-6, high omega-3 fat diet combined with fish oil. Patients also receive 4 fish oil capsules per day PO for 1 year.
干预措施: behavioral dietary intervention (Behavioral)
Arm II (fish oil)
Patients receive dietary counseling with research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low omega-6, high omega-3 fat diet combined with fish oil. Patients also receive 4 fish oil capsules per day PO for 1 year.
干预措施: laboratory biomarker analysis (Other)
Arm I (control)
Patients receive no intervention.
结局指标
主要结局
Ki-67 index
时间窗: 1 year
The primary statistical analysis will be to compare the Ki67 index between the two intervention arms using a negative binomial mixed effects model
次要结局
- Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer)(1 year)
- Serum PSA(Up to 1 year)
- Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)(Up to 15 years)
- Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)(Up to 1 year)
- Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score(Up to 1 year)
- Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count(Up to 1 year)
- Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0(Up to 1 year)
- Sample storage for future research(Up to 1 year)