Effects of Tomato-Soy Juice on Biomarkers in Patients With Prostate Cancer Undergoing Prostatectomy

October 15, 2014 updated by: Steven Clinton, Ohio State University Comprehensive Cancer Center

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

RATIONALE: Tomato-soy juice may slow the growth of tumor cells. Studying samples of blood and tissue from patients with prostate cancer in the laboratory may help doctors identify biomarkers related to cancer. It may also help doctors understand the effect of tomato-soy juice on biomarkers.

PURPOSE: This phase I/II trial is studying the side effects of tomato-soy juice and its effect on biomarkers in patients with prostate cancer undergoing prostatectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

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

Secondary

  • 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 metabolites.
  • 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 prostatectomy.

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

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Biopsy proven carcinoma of the prostate.
  • Have chosen radical prostatectomy (or cystoprostatectomy) for treatment of their disease after presented all possible options by medical team.
  • Not receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  • Not currently taking lycopene, soy dietary supplements, or "alternative" products (i.e. PC-SPES, Saw Palmetto).
  • BUN/Cr (Blood urea nitrogen and serum creatinine), liver enzymes, CBC (complete blood count), and PT/PTT/INR (prothrombin time/partial thromboblastin time) within normal limits.
  • Voluntarily agree to participate and a 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.

Exclusion:

  • Active malignancy other than prostate cancer that requires therapy.
  • History of traumatic or surgical castration.
  • History of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
  • Are taking certain medications. No concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of BPH (benign prostate hyperplasia). Utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted. The use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products).
  • Have certain medical conditions including: malabsorptive disorders or other metabolic disorders requiring special diet recommendations, severe constipation (may be accentuated by soy), a recent history of anemia or iron deficiency (possible accentuation by soy), or hypertension that requires a strict low sodium diet (tomato juice is high in sodium). The severity of these conditions and eligibility will be defined after careful review of the medical records by Dr. Clinton.
  • Have a known allergy to soy or tomato components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence and severity of toxicity associated with tomato-soy juice

Secondary Outcome Measures

Outcome Measure
Changes in the content and distribution of soy isoflavones and tomato phytochemicals (carotenoids and polyphenols) to the prostate and correlation of tissue content and patterns with blood and urinary concentrations of these compounds and their metab ...
Blood hormonal patterns and biomarkers of oxidative stress that favor prostate cancer prevention
Histopathologic and molecular biomarkers associated with prostate carcinogenesis that may serve as surrogate endpoint biomarkers and their ability to be modulated by the tomato-soy juice
Systemic hormones, cell/matrix interactions in the tumor microenvironment, and molecular processes within the tumor cells, including tumor grade and nuclear morphometry, tumor stage, proliferation index, apoptotic index, and angiogenesis/vascularity
Alteration of 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 ( ...

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Steven K. Clinton, MD, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-07041
  • NCI-2012-01373 (Registry Identifier: Clinical Trials Reporting Program (CTRP))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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