Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease progression of prostate cancer. PURPOSE: Randomized phase II trial to study the effectiveness of a diet that is low in fat and/or high in flaxseed in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.

Detailed Description
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OBJECTIVES: Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat- and/or flaxseed-modified diets. Compare differences in histopathological markers associated with prostate cancer (rates of apoptosis, extent of high-grade prostatic intraepithelial neoplasia) among patients in these diet groups. Compare changes in serum prostate specific antigen among patients in these diet groups. Compare changes in hormone-related factors (total serum testosterone and free androgen index, insulin-like growth factor [IGF], and IGF-binding protein-3) among patients in these diet groups. Compare the effects of diet on nutritional biomarkers (levels of lignans in the urine and ejaculate, fatty acid profiles of erythrocytes and prostatic tissue) in these patients. Determine associations between dietary modification and changes in dietary biomarkers, hormonal intermediates, and study endpoints in these patients. OUTLINE: This is a randomized study. Patients are stratified according to Gleason score (less than 7 vs at least 7) and race (black vs non-black). Patients are randomized to 1 of 4 diet groups. Arm I (Flaxseed-supplemented diet): Patients are instructed to incorporate ground flaxseed into their daily diets. Arm II (Low-fat diet): Patients are instructed on ways to achieve a diet with no greater than 20% of total energy from dietary fat. Arm III (Flaxseed-supplemented, low-fat diet): Patients are instructed as in arm I and arm II. Arm IV (Control diet): Patients are contacted weekly, but do not receive dietary counseling until after surgery. All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery. After surgery, all patients receive dietary counseling. PROJECTED ACCRUAL: A total of 160 patients (40 per treatment arm) will be accrued for this study.

Official Title
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Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: dietary intervention
* Dietary Supplement: flaxseed


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer At least 3 weeks until planned prostatectomy (24 days between day 1 visit and surgery) Current diet that provides more than 30% of calories from fat PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Mentally competent Able to speak and write English Must have telephone access PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No concurrent hormonal therapy Radiotherapy Not specified Surgery At least 2 weeks since prior prostate biopsy Other At least 7 days since prior antibiotics No prior therapy for prostate cancer No concurrent dietary supplements initiated within the past 3 months or anticipated to begin during study except standard multivitamin/mineral preparations (e.g., One-A-Day, Theragran, or Centrum) that do not supply > 100% of the recommended daily allowance of any vitamin or mineral No other concurrent neoadjuvant therapies No other concurrent flaxseed consumption

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual diet | |
| Experimental: Flaxseed diet<br>30 gram flaxseed dietary modification | Dietary Supplement: flaxseed<br> <br> |
| Experimental: Low fat diet<br>Low fat dietary modification | Dietary Supplement: dietary intervention<br> <br> |
| Experimental: Low fat + Flaxseed diet<br>Low fat and 30 gram flaxseed dietary modification | Dietary Supplement: dietary intervention<br> <br> Dietary Supplement: flaxseed<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy |  |  | 
| Prostate-specific antigen by Hybritech assay at baseline and follow-up |  |  | 
| Total testosterone, sex hormone binding globulin, insulin-like growth factor (IGF), and IGF-binding protein-3, total cholesterol, and low-density lipoprotein cholesterol by ELISA assays at baseline and follow-up |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer