Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

Prostate Cancer Clinical Trial

Official title:

The Effect of Lycopene on DNA Damage in Human Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416390
• Other study ID #: CDR0000492778
• Secondary ID: UIC-1999-0489
• Status: Completed
• Phase: N/A
• First received: December 27, 2006
• Last updated: September 19, 2013
• Est. completion date: March 2011

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nonmalignant Neoplasm
• Prostate Cancer
• Prostatic Hyperplasia
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• lycopene

Other:
• laboratory biomarker analysis

Procedure:
• biopsy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of prostatic tissue to accumulate doses of lycopene			No
Primary	Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing			No
Primary	Effect of lycopene on lipid peroxidation marker malondialdehyde in serum			No
Primary	Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention			No
Primary	Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate			No
Primary	Prostate and blood uptake of the chemoprevention agent lycopene			No