The Effect of Lycopene on DNA Damage in Human Prostate
- 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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Ability of prostatic tissue to accumulate doses of lycopene
Richard B. van Breemen, PhD
University of Illinois
United States: Federal Government