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.
Masking: Open Label, Primary Purpose: Treatment
Incidence and severity of toxicity associated with tomato-soy juice
Steven K. Clinton, MD, PhD
Ohio State University Comprehensive Cancer Center
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|