Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Other Dietary Supplements

Lycopene

Tomato

Tangerine

Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)

Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).

Group II will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks).

dietary intervention (tangerine tomato juice)

Group III will consume two 5.5 oz. cans of red tomato juice every day until their scheduled surgery (approximately 4 weeks).red tomato juice

dietary intervention (red tomato juice)

Men enrolled in the study will be asked to complete a 3-Day Food Record and a series of additional questionnaires (urologic symptom and quality of life questionnaire) at home.

questionnaire administration

Blood and urine samples at enrollment and blood, urine, and prostate tissue at the time of surgery to determine compliance with the intervention product and tomato phytochemical biodistribution. Additionally, we will correlate each type of tomato juice with lycopene presence in plasma, urine, and tissue provided by subjects on the day of surgery.

Correlative studies

Steven Schwartz, Ph.D.

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.

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).

Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery

A Comparison of Tangerine and Red Tomato Juice in Men With Prostate Cancer: A Pilot Study

Linear regression analysis will be used to examine differences in carotenoid levels of biological samples between groups.

Compared via 3 way analysis of variance (ANOVA) with pairwise comparisons or nonparametric Kruskal-Wallis tests where appropriate.

Compared via 3 way ANOVA with pairwise comparisons, or nonparametric Kruskal-Wallis tests where appropriate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery	NCT02144649	Stage I Prostat... Stage IIA Prost... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	dietary interve... dietary interve... questionnaire a... Correlative stu...	21 Years -	Ohio State University Comprehensive Cancer Center
Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery	NCT02144649	Stage I Prostat... Stage IIA Prost... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	dietary interve... dietary interve... questionnaire a... Correlative stu...	21 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for dietary intervention (red tomato juice)