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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01009736
First received: November 6, 2009
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: tomato-soy juice
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: therapeutic conventional surgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biomarkers of Prostate and Cardiovascular Health of Men Undergoing Prostatectomy Consuming Different Amounts of Soy-Tomato Juice

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Incidence and severity of toxicity associated with tomato-soy juice [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ... [ Designated as safety issue: No ]
  • Blood hormonal patterns and biomarkers of oxidative stress that favor prostate cancer prevention [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • 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 ( ... [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2008
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009736

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Steven K. Clinton, MD, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01009736     History of Changes
Other Study ID Numbers: OSU-07041, NCI-2012-01373
Study First Received: November 6, 2009
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014