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Completed

NCT Number: NCT00416390

Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

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.

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Key information

Conditions

Nonmalignant Neoplasm Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Hyperplasia Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lycopene

Dietary Supplement

laboratory biomarker analysis

Other

Biopsy

Procedure

Primary outcomes

  1. Ability of prostatic tissue to accumulate doses of lycopene

  2. Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing

  3. Effect of lycopene on lipid peroxidation marker malondialdehyde in serum

  4. Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention

  5. Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate

  6. Prostate and blood uptake of the chemoprevention agent lycopene

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Effect of Lycopene on DNA Damage in Human Prostate

Important dates

Study completion
2011
First posted
Dec 28, 2006
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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