Trial Information

The Effect of Lycopene on DNA Damage in Human Prostate

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.