Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia
|ClinicalTrials.gov Identifier: NCT00416390|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : September 20, 2013
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 or disease||Intervention/treatment||Phase|
|Nonmalignant Neoplasm Prostate Cancer||Dietary Supplement: lycopene Other: laboratory biomarker analysis Procedure: biopsy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Official Title:||The Effect of Lycopene on DNA Damage in Human Prostate|
|Actual Study Completion Date :||March 2011|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416390
|Principal Investigator:||Richard B. van Breemen, PhD||University of Illinois at Chicago|