Nonmalignant Neoplasm, Prostate Cancer
Conditions
Keywords
benign prostatic hyperplasia, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTlycopene
OTHERlaboratory biomarker analysis
PROCEDUREbiopsy
Sponsors
National Cancer Institute (NCI)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed