Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Nonmalignant Neoplasm Prostate Cancer

Keywords

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benign prostatic hyperplasia stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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lycopene

Intervention Type DIETARY_SUPPLEMENT

laboratory biomarker analysis

Intervention Type OTHER

biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Richard B. van Breemen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

References

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van Breemen RB, Sharifi R, Viana M, Pajkovic N, Zhu D, Yuan L, Yang Y, Bowen PE, Stacewicz-Sapuntzakis M. Antioxidant effects of lycopene in African American men with prostate cancer or benign prostate hyperplasia: a randomized, controlled trial. Cancer Prev Res (Phila). 2011 May;4(5):711-8. doi: 10.1158/1940-6207.CAPR-10-0288. Epub 2011 Mar 23.

Reference Type DERIVED

PMID: 21430075 (View on PubMed)

Other Identifiers

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UIC-1999-0489

Identifier Type: -

Identifier Source: secondary_id

CDR0000492778