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Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416390
First Posted: December 28, 2006
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.


Condition Intervention
Nonmalignant Neoplasm Prostate Cancer Dietary Supplement: lycopene Other: laboratory biomarker analysis Procedure: biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Lycopene on DNA Damage in Human Prostate

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Ability of prostatic tissue to accumulate doses of lycopene
  • Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing
  • Effect of lycopene on lipid peroxidation marker malondialdehyde in serum
  • Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
  • Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate
  • Prostate and blood uptake of the chemoprevention agent lycopene

Estimated Enrollment: 120
Study Completion Date: March 2011
Detailed Description:

OBJECTIVES:

  • Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
  • Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
  • Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
  • Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
  • Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
  • Measure prostate and blood uptake of the chemoprevention agent lycopene.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral lycopene once daily for 3 weeks.
  • Arm II: Patients receive oral placebo once daily for 3 weeks. In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy.

Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Prostate cancer
    • Benign prostate hyperplasia
  • High blood levels of prostate-specific antigen
  • Enlarged prostate

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416390


Sponsors and Collaborators
University of Illinois at Chicago
National Cancer Institute (NCI)
Investigators
Principal Investigator: Richard B. van Breemen, PhD University of Illinois at Chicago
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00416390     History of Changes
Other Study ID Numbers: CDR0000492778
UIC-1999-0489
First Submitted: December 27, 2006
First Posted: December 28, 2006
Last Update Posted: September 20, 2013
Last Verified: October 2007

Keywords provided by National Cancer Institute (NCI):
benign prostatic hyperplasia
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
Hyperplasia
Prostatic Hyperplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pathologic Processes
Lycopene
Carotenoids
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents