Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

University of Illinois

Status: Completed

Conditions: Nonmalignant Neoplasm; Prostate Cancer

Treatments: Other: laboratory biomarker analysis; Dietary Supplement: lycopene; Procedure: biopsy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00416390

CDR0000492778

UIC-1999-0489

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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