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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Incidence and severity of toxicity associated with tomato-soy juice

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Prostate Cancer

Clinical Trials on pharmacological study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings