Prostate Cancer Clinical Trial
Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Los Angeles California, 90095, United States
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