Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: A low-fat, high-fiber diet may slow the growth of prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of a low-fat, high-fiber diet with that of a standard diet in treating patients who have prostate cancer.

Detailed Description
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OBJECTIVES: Compare the inhibition of growth of human prostate cancer cell lines by serum from patients with prostate cancer before and after being fed a low fat, high fiber diet. Determine the underlying mechanism through which a low fat, high fiber diet affects the growth of prostate cancer cell lines. Determine whether a low fat, high fiber diet inhibits the growth of prostate cancer cell lines through androgen-dependent and/or androgen- independent mechanisms in these patients. Determine the growth factors, hormones, and/or binding proteins that may be responsible for affecting the growth of prostate cancer cell lines in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 arms. Arm I: Patients receive a low fat, high fiber diet daily for 3 weeks. Arm II: Patients receive a control diet containing the standard amounts of fat and fiber. PROJECTED ACCRUAL: A total of 40 patients (20 per arm) will be accrued for this study within 6 months.

Official Title
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Effects of a Low Fat Diet on Serum Factors and Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: therapeutic dietary intervention


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the prostate Previously untreated and on watchful waiting Medically able to receive dietary intervention PATIENT CHARACTERISTICS: Age: 40 to 80 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be willing to travel to UCLA 3 days a week for 4 weeks to obtain specially prepared foods PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent luteinizing hormone-releasing hormone agonists (leuprolide or goserelin) No concurrent androgen-receptor blocking agents (flutamide or bicalutamide) No concurrent testosterone No concurrent insulin No concurrent finasteride Radiotherapy: Not specified Surgery: No prior orchiectomy Other: No concurrent saw palmetto supplement

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: therapeutic dietary intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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