Lycopene in Preventing Prostate Cancer in Healthy Participants

Prostate Cancer Clinical Trial

Official title: Mechanism of Prostate Cancer Prevention by Lycopene

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00322114
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: N/A
• Start date: February 2006