Prostate Cancer Clinical Trial
Official title:
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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