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

Not Applicable

Completed

• Conditions: Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IV Prostate Cancer; Stage III Prostate Cancer; Stage IIB Prostate Cancer
• Interventions: Dietary Supplement: dietary intervention (tangerine tomato juice); Dietary Supplement: dietary intervention (red tomato juice); Other: questionnaire administration; Other: Correlative studies

• Registration Number: NCT02144649
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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).

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-22
• Study Start: 2015-06
• Primary Completion: 2016-09-22
• Study Completion: 2016-09-22
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

Inclusion Criteria

• Have biopsy proven carcinoma of the prostate
• Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
• Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Not currently be taking tomato carotenoid dietary supplements or "alternative" products (e.g., lycopene supplements, Lyc-O-Mato, saw palmetto); vitamin A and beta-carotene supplements are allowed
• Not be allergic to tomatoes or tomato products
• Have plasma total cholesterol < 200 mg/dL
• Plasma triglycerides < 200 mg/dL
• Have blood urea nitrogen and serum creatinine (BUN/Cr) without clinically significant abnormalities after review by the study physicians
• Liver enzymes without clinically significant abnormalities after review by the study physicians
• Complete blood count (CBC) without clinically significant abnormalities after review by the study physicians
• Prothrombin time (PT) without clinically significant abnormalities after review by the study physicians
• Partial thromboplastin time (PTT) without clinically significant abnormalities after review by the study physicians
• International normalized ratio (INR) without clinically significant abnormalities after review by the study physicians
• Voluntarily agree to participate and sign an informed consent document
• Agree to have prostate biopsy blocks provided to the study for evaluation
• Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
• Agree to follow a low lycopene and phytoene diet

Exclusion Criteria

• Have an active malignancy other than prostate cancer that requires therapy
• Have a prostate biopsy with less than 5% cancer involvement
• Have a history of traumatic or surgical castration
• Have plasma total cholesterol > 200 mg/dL
• Have plasma triglycerides > 200 mg/dL
• Have a history of uncontrolled pituitary hormone diseases that currently require varying doses of supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring varying doses of hormone administration with the exception of diabetes and osteoporosis
• Are planning to start certain medications after the trial enrollment; no new finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing new prescription medications for urinary outlet obstructive symptoms will result in discontinuing participation in this study; the use of new non-prescription substances to improve urinary tract symptoms will also result in discontinuing participation (i.e. saw palmetto, other herbal, alternative products); men who are currently taking finasteride or medications (meds) for urinary outlet obstructive symptoms may enroll in the study as long as there is no plan to change the dose in the weeks prior to surgery
• Have a known allergy to tomatoes or have never consumed tomatoes
• Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
• Have significant loss of gastrointestinal organs, except for appendix, due to surgery
• Have altered immunity such as autoimmune disorders, clinically significant anemia, hemophilia, and blood dyscrasias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (tangerine tomato juice)	dietary intervention (tangerine tomato juice)	Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
Group III (red tomato juice)	questionnaire administration	Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
Group II (tangerine tomato juice)	questionnaire administration	Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)
Group III (red tomato juice)	dietary intervention (red tomato juice)	Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
Group III (red tomato juice)	Correlative studies	Patients consume two cans of red tomato juice daily until their scheduled surgery (approximately 4 weeks).
Group II (tangerine tomato juice)	Correlative studies	Patients will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks)

Primary Outcome Measures

Name	Time	Method
Compliance of daily consumption of tangerine tomato juice or red tomato juice	Up to time of surgery
Incidence of toxicity	Up to time of surgery
Differences in carotenoid levels of biological samples between groups	Up to time of surgery	Linear regression analysis will be used to examine differences in carotenoid levels of biological samples between groups.

Secondary Outcome Measures

Name	Time	Method
Change in histopathologic markers between the treatment groups	Baseline to time of surgery	Compared via 3 way analysis of variance (ANOVA) with pairwise comparisons or nonparametric Kruskal-Wallis tests where appropriate.
Change in immunohistochemical markers between the treatment groups	Baseline to time of surgery	Compared via 3 way ANOVA with pairwise comparisons, or nonparametric Kruskal-Wallis tests where appropriate.

Trial Locations

Locations (2)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

OhioHealth Dublin Methodist Hospital; 🇺🇸 Dublin, Ohio, United States