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

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).

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