NCT00322114

Lycopene in Preventing Prostate Cancer in Healthy Participants

Mechanism of Prostate Cancer Prevention by Lycopene

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	lycopene	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-02-01
• First posted: 2006-05-04
• Last updated: 2013-09-20

Locations

1 site across 1 country: United States