Lycopene in Preventing Prostate Cancer in Healthy Participants

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT00322114
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.

PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.

Detailed Description

OBJECTIVES:

Primary

* Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.

Secondary

* Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.

* Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.

OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.

* Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.

* Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.

* Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.

PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-05-03
• Study First Submitted QC: 2006-05-03
• Study First Posted: 2006-05-04
• Primary Completion: 2009-02
• Status Verified: 2009-07
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene

Trial Locations

Locations (1)

University of Illinois Cancer Center; 🇺🇸 Chicago, Illinois, United States