NCT00322114

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

September 20, 2013

Status Verified

July 1, 2009

Enrollment Period

3 years

First QC Date

May 3, 2006

Last Update Submit

September 19, 2013

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

Arm I

EXPERIMENTAL

Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.

Dietary Supplement: lycopene

Arm II

EXPERIMENTAL

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

Dietary Supplement: lycopene

Arm III

PLACEBO COMPARATOR

Participants receive oral placebo twice daily for 3 weeks.

Other: placebo

Interventions

lycopeneDIETARY_SUPPLEMENT

Given orally

Arm IArm II
placeboOTHER

Given orally

Arm III

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Richard B. van Breemen, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2006

First Posted

May 4, 2006

Study Start

February 1, 2006

Primary Completion

February 1, 2009

Last Updated

September 20, 2013

Record last verified: 2009-07

Locations

US(1)