Prostate Cancer Clinical Trial
Official title:
Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
or coming back. The use of fish oil and/or green tea may prevent prostate cancer.
PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea
supplement works in preventing prostate cancer in patients with prostatic intraepithelial
neoplasia or who are at risk for developing prostate cancer.
OBJECTIVES:
- Determine the cancer preventing effects of fish oil supplementation and green tea
extract use on markers of alteration in lipid metabolism in prostate tissue samples.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4
treatment arms.
- Arm I: Patients receive oral fish oil three times daily and oral green tea extract
twice daily.
- Arm II: Patients receive an oil placebo three times daily and oral green tea extract
twice daily.
- Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.
- Arm IV: Patients receive an oil placebo three times daily and another placebo twice
daily.
Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of
disease progression or unacceptable toxicity.
All patients undergo a prostate biopsy on the last day of study treatment.
After completion of study treatment, patients receive a follow-up phone call at/around 30
days later.
PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.
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