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Biomarkers of Prostate and Cardiovascular Health of Men Undergoing Prostatectomy Consuming Different Amounts of Soy-Tomato Juice

Phase 1/Phase 2
Open (Enrolling)
Prostate Cancer

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Trial Information

Biomarkers of Prostate and Cardiovascular Health of Men Undergoing Prostatectomy Consuming Different Amounts of Soy-Tomato Juice



- Determine the incidence and severity of toxicity associated with tomato-soy juice in
patients undergoing prostatectomy.


- Quantify changes in the content and distribution of soy isoflavones and tomato
phytochemicals (carotenoids and polyphenols) to the prostate and correlate tissue
content and patterns with blood and urinary concentrations of these compounds and their

- Determine blood hormonal patterns and biomarkers of oxidative stress that favor
prostate cancer prevention.

- Investigate histopathologic and molecular biomarkers associated with prostate
carcinogenesis that may serve as surrogate endpoint biomarkers and provide information
regarding their ability to be modulated by the tomato-soy juice.

- Examine several critical histopathologic endpoints, including systemic hormones,
cell/matrix interactions in the tumor microenvironment, and molecular processes within
the tumor cells (tumor grade and nuclear morphometry, tumor stage, proliferation index,
apoptotic index, and angiogenesis/vascularity).

- Determine if consumption of tomato-soy juice alters molecular markers in the human
prostate, including neuroendocrine markers such as IGF-I and IGF-BP3, signal
transduction markers such as PTEN (phosphatase and tensin homologue) and phospho-AKT,
and angiogenesis regulators such as VEGF (vascular epithelial growth factor).

OUTLINE: Patients receive tomato-soy juice daily for 4 weeks. Patients then undergo

Patients complete urologic symptom and quality-of-life questionnaires.

Blood, urine, and tissue samples are collected for biomarker and pharmacokinetic analysis.

Inclusion Criteria


- Biopsy-proven carcinoma of the prostate

- Has chosen to undergo a radical prostatectomy (or cystoprostatectomy) for treatment
of disease after the medical team has presented all possible treatment options


- ECOG performance status 0-1

- BUN/creatinine, liver enzymes, complete blood count, and PT/PTT/INR normal

- Agrees to have prostate biopsy blocks provided to the study for evaluation

- Agrees to consume a standardized vitamin and mineral supplement and avoid other
nutritional, dietary, or alternative medications/supplements for the duration of the

- No other active malignancy that requires therapy

- No history of pituitary hormone diseases that currently require supplemental hormonal
administration (thyroid hormones, ACTH, growth hormone) or other endocrine disorders
requiring hormone administration (except for diabetes or osteoporosis)

- No medical conditions, including malabsorptive disorders or other metabolic disorders
requiring special dietary recommendations, severe constipation, recent history of
anemia or iron deficiency, or hypertension that requires a strict low-sodium diet

- No known allergy to soy or tomato components


- No prior traumatic or surgical castration

- No concurrent neoadjuvant hormonal therapy or chemotherapy (other clinical trials)

- No other concurrent lycopene, soy dietary supplements, or "alternative" products
(i.e., PC-SPES, or Saw Palmetto)

- No concurrent finasteride (Proscar) or other hormonal agents for
chemoprevention/treatment of benign prostate hyperplasia

- No concurrent prescription medications for urinary outlet obstructive symptoms

- No concurrent non-prescription substances to improve urinary tract symptoms (i.e.,
Saw Palmetto or other herbal or alternative products)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of toxicity associated with tomato-soy juice

Safety Issue:


Principal Investigator

Steven K. Clinton, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center



Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240