Spots Global Cancer Trial Database for Lycopene or Omega-3 Fatty Acid Nutritional Supplements in Treating Patients With Stage I or Stage II Prostate Cancer

Study Description

Brief Summary: RATIONALE: The use of lycopene, a substance found in tomatoes, or omega-3 fatty acid nutritional supplements may keep cancer from growing in patients with prostate cancer. PURPOSE: This randomized clinical trial is studying lycopene to see how well it works compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II prostate cancer.

Detailed Description: OBJECTIVES: Primary * Compare gene expression in normal prostate tissue (at baseline and after treatment) of patients with stage I or II adenocarcinoma of the prostate treated with lycopene vs omega-3 fatty acid nutritional supplements vs placebo. Secondary * Determine new candidate molecular targets for lycopene and omega-3 response pathways. * Correlate baseline gene expression patterns, determined by cDNA array analysis, with self-reported dietary intake. * Correlate gene expression patterns with progression or lack of progression at 12 months after study entry. * Determine if lycopene or omega-3 supplements affect the incidence of tumor progression. OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified according to dietary intake of tomato and fish (low tomato \[\< 4 servings/week\], low fish \[\< 2 servings/week\] vs low tomato, high fish \[≥ 2 servings/week\] vs high tomato \[≥ 4 servings/week\], low fish vs high tomato, high fish). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients maintain normal diet and receive oral omega-3 fatty acids placebo 3 times daily and lycopene placebo twice daily. * Arm II: Patients receive oral lycopene twice daily and oral omega-3 fatty acids placebo 3 times daily. * Arm III: Patients receive oral lycopene placebo twice daily and oral omega-3 fatty acids 3 times daily. In all arms, treatment continues for up to 90 days or until post-treatment biopsy is scheduled (a maximum of 104 days) in the absence of disease progression. Patients complete a dietary questionnaire at baseline and then for 3 days each month during study therapy. Quality of life is assessed at baseline and at 3 months. Prostate tissue needle biopsies and blood samples are collected at baseline and at 3 months. Tissue and blood samples are examined for lycopene and omega-3 fatty acids (treatment compliance), omega-6 fatty acids, insulin-like growth factor (IGF)-1, IGF binding protein-5, and cyclooxygenase-2 gene by polymerase chain reaction, cDNA microarray hybridization, and other gene expression assays. After completion of study treatment, patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 114 patients will be enrolled in this study.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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