Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416390
First received: December 27, 2006
Last updated: September 19, 2013
Last verified: October 2007
  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
Nonmalignant Neoplasm
Prostate Cancer
Dietary Supplement: lycopene
Other: laboratory biomarker analysis
Procedure: biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Lycopene on DNA Damage in Human Prostate

Resource links provided by NLM:


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
Study Completion Date: March 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Richard B. van Breemen, PhD University of Illinois at Chicago
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00416390     History of Changes
Other Study ID Numbers: CDR0000492778, UIC-1999-0489
Study First Received: December 27, 2006
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
benign prostatic hyperplasia
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Hyperplasia
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Lycopene
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014