Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 232
- 试验地点
- 4
- 主要终点
- Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
研究概览
简要总结
RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of prostate cancer.
PURPOSE: This randomized clinical trial is studying polyunsaturated fatty acids in treating patients with prostate cancer undergoing prostate biopsy and/or surgery.
详细描述
OBJECTIVES:
- Compare fatty acid analysis of red blood cells, levels of eIF2α phosphorylation, and tumor differentiation grade, as measured by Gleason score, in patients undergoing prostate biopsy. (Part 1)
- Determine if neoadjuvant n-3 polyunsaturated fatty acids (PUFAs) induce phosphorylation of eIF2α in these patients. (Part 2)
- Compare eIF2α phosphorylation, Gleason score, and the time to prostate-specific antigen failure in prostate tumor samples obtained from the Gelb Center of the Dana-Farber Cancer Institute prostate tissue repository. (Part 3)
OUTLINE: This is a prospective study, followed by a randomized, double-blind, placebo-controlled study, followed by a retrospective study.
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Part 1: Patients undergo tumor biopsy and blood sample collection at baseline. Samples are analyzed by gas-liquid chromatography for determination of n-3 and n-6 polyunsaturated fatty acid (PUFA) red cell membrane concentrations. Biopsy samples are analyzed for eIF2α phosphorylation by immunohistochemistry. Some patients proceed to part 2.
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Part 2: Patients undergo blood sampling as in part 1 with additional tumor and blood collection on day 28. Patients are randomized to 1 of 2 treatment arms.
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Arm I: Patients receive oral n-3 PUFAs (fish oil) once daily for 28 days prior to tumor resection.
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Arm II (control): Patients receive oral n-6 PUFAs (corn oil) once daily for 28 days prior to tumor resection.
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Part 3: Tumor samples and associated pathology data (Gleason score) and clinical data (PSA values and patient's outcome) are obtained from a prostate tissue repository at the Gelb Center of the Dana-Farber Cancer Institute. Samples are analyzed to correlate eIF2α phosphorylation, Gleason scores, and time to PSA failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men undergoing an outpatient prostate biopsy independently indicated by a physician.
- •Patients will be selected from the population initially studied with a prostate biopsy for possible prostate cancer
- •sub-group without evidence of cancer
- •sub-group with advanced prostate cancer beyond the currently accepted criteria for surgical treatment,
- •sub-group with indication of radical prostatectomy
- •Patients will be recruited from the population of patients from Brigham and Women's Hospital for surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made. These patients are not eligible for Aim 1 but will enter the randomized trial (Aim 2 with baseline)
排除标准
- •Prostate biopsy patients who do not accept and sign an informed consent form to
- •donate ten ml of blood for fatty acid analysis in red blood cells
- •allow their prostate biopsy to be analyzed as discarded pathological material
- •authorize access to their hospital clinical information for follow up studies
- •Patients with a current diagnosis of a condition that might interfere with the measurements of fatty acids in red blood cell membranes such as severe anemia (less than 9g/100m1% hemoglobin
- •Diseases of lipid metabolism such as familial dyslipoproteinemia, liver cirrhosis, advanced renal failure, and malabsorption syndrome.
- •Exclude from this study patients from (indication of radical prostatectomy) who refuse the surgical recommendation or schedule surgery at a location other than Brigham and Women's Hospital.
- •Patients who are not able to complete the full program will not be taken into consideration in the final data analysis.
研究组 & 干预措施
omega-3 fatty acids
omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
干预措施: omega-3 fatty acids (Dietary Supplement)
omega-3 fatty acids
omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
干预措施: biopsy (Procedure)
Corn Oil
Oral 8g once a day for 21 days prior to (biopsy) surgery
干预措施: biopsy (Procedure)
结局指标
主要结局
Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
时间窗: 21 Days
Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2)
时间窗: 21 Days
次要结局
- Relapse-free survival (Part 2)(Time between surgery and the time of PSA failure 6 months and 9 months)
研究者
Jose A. Halperin
Principal Investigator
Dana-Farber Cancer Institute