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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01009736
First received: November 6, 2009
Last updated: February 18, 2011
Last verified: November 2009
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Primary Completion Date: June 2009 (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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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 study
  • 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

PRIOR CONCURRENT THERAPY:

  • 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)
  Contacts and Locations
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 Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven K. Clinton, MD, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Steven K. Clinton, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01009736     History of Changes
Other Study ID Numbers: CDR0000642377, OSU-2007C0026
Study First Received: November 6, 2009
Last Updated: February 18, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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 May 16, 2013