Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416390
First received: December 27, 2006
Last updated: September 19, 2013
Last verified: October 2007

December 27, 2006
September 19, 2013
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  • Ability of prostatic tissue to accumulate doses of lycopene [ Designated as safety issue: No ]
  • Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing [ Designated as safety issue: No ]
  • Effect of lycopene on lipid peroxidation marker malondialdehyde in serum [ Designated as safety issue: No ]
  • Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention [ Designated as safety issue: No ]
  • Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate [ Designated as safety issue: No ]
  • Prostate and blood uptake of the chemoprevention agent lycopene [ Designated as safety issue: No ]
  • 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
Complete list of historical versions of study NCT00416390 on ClinicalTrials.gov Archive Site
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Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia
The Effect of Lycopene on DNA Damage in Human Prostate

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.

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.

Interventional
Not Provided
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
  • Nonmalignant Neoplasm
  • Prostate Cancer
  • Dietary Supplement: lycopene
  • Other: laboratory biomarker analysis
  • Procedure: biopsy
Not Provided
van Breemen RB, Sharifi R, Viana M, Pajkovic N, Zhu D, Yuan L, Yang Y, Bowen PE, Stacewicz-Sapuntzakis M. Antioxidant effects of lycopene in African American men with prostate cancer or benign prostate hyperplasia: a randomized, controlled trial. Cancer Prev Res (Phila). 2011 May;4(5):711-8. doi: 10.1158/1940-6207.CAPR-10-0288. Epub 2011 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2011
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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
Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00416390
CDR0000492778, UIC-1999-0489
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Not Provided
University of Illinois at Chicago
National Cancer Institute (NCI)
Principal Investigator: Richard B. van Breemen, PhD University of Illinois at Chicago
National Cancer Institute (NCI)
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP