Lycopene in Preventing Prostate Cancer in Healthy Participants

Mechanism of Prostate Cancer Prevention by Lycopene

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00322114

Enrollment

150

Registered

2006-05-04

Start date

2006-02-28

Completion date

Unknown

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer

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.

Interventions

DIETARY_SUPPLEMENTlycopene

Given orally

OTHERplacebo

Given orally

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

DISEASE CHARACTERISTICS: * Healthy participants * No existing prostate disease PATIENT CHARACTERISTICS: * Able to supply blood and urine samples * Able to answer demographic and dietary recall questionnaires * No hospital inpatients * Not allergic to tomatoes or tomato products * Not abusing alcohol or non-prescribed drugs * No existing gastrointestinal disease or cancer PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior lycopene (in supplement form) * No concurrent participation in another clinical trial

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026