Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia - Full Text View

Sponsors and Collaborators:	University of Illinois National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00416390

Purpose

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.

Condition	Intervention
Precancerous/Nonmalignant Condition Prostate Cancer	Dietary Supplement: lycopene Other: laboratory biomarker analysis Procedure: biopsy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	The Effect of Lycopene on DNA Damage in Human Prostate

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diets Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Ability of prostatic tissue to accumulate doses of lycopene [ Designated as safety issue: No ]
Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing [ Designated as safety issue: No ]
Effect of lycopene on lipid peroxidation marker malondialdehyde in serum [ Designated as safety issue: No ]
Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention [ Designated as safety issue: No ]
Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate [ Designated as safety issue: No ]
Prostate and blood uptake of the chemoprevention agent lycopene [ Designated as safety issue: No ]

Estimated Enrollment:

120

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416390

Sponsors and Collaborators

University of Illinois

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Richard B. van Breemen, PhD

University of Illinois

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000492778, UIC-1999-0489
Study First Received:	December 27, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00416390 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

benign prostatic hyperplasia
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Precancerous Conditions
Genital Neoplasms, Male
Prostatic Diseases
DNA Damage

Lycopene
Urogenital Neoplasms
Genital Diseases, Male
Hyperplasia
Prostatic Hyperplasia
Prostatic Neoplasms

Additional relevant MeSH terms:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Precancerous Conditions
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lycopene
Physiological Effects of Drugs

Urogenital Neoplasms
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Prostatic Hyperplasia
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009