Spots Global Cancer Trial Database for Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery

Study Description

Brief Summary: This randomized pilot clinical trial compares tangerine and red tomato juice in treating patients with prostate cancer undergoing surgery. A diet high in lycopene, a substance found in tomatoes, may help prevent normal cells from transforming into cancer cells in patients with prostate cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To conduct a randomized, three-arm pilot clinical trial to determine compliance and safety of daily consumption of tangerine tomato juice or red tomato juice. SECONDARY OBJECTIVES: I. To quantify total carotenoids, total lycopene (LYC), cis-LYC, trans-LYC, phytoene, phytofluene, and lycopene metabolites in plasma and prostate tissue in the three groups of men. II. To evaluate serum biomarkers related to prostate carcinogenesis, including those previously impacted by tomato phytochemicals (testosterone, sex hormone-binding protein \[SHBP\], insulin-like growth factor \[IGF\]-I, IGF-binding protein \[BP\]3, vascular endothelial growth factor \[VEGF\], and a panel of anti-inflammatory cytokines) by validated assays. III. To evaluate molecular signatures using the 200 gene quantitative Nano-string nCounter code set (selected genes known to be impacted by dietary components, genes impacted by common prostate genetic and epigenetic damage, and those regulated by testosterone) and micro-ribonucleic acid (RNA) nCounter code set. IV. To plot the distribution of carotenoid metabolites across the matrix versus the epithelium and cancer versus non-cancer areas of the prostate using matrix-assisted laser desorption ionization (MALDI) imaging of a limited number of samples. OUTLINE: Patients are randomized to 1 of 3 treatment groups. GROUP I: Patients consume no tomato juice. GROUP II: Patients consume two cans of tangerine tomato juice daily until their scheduled surgery (approximately 4 weeks). GROUP III: Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).

Keywords

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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