Lycopene in Preventing Prostate Cancer in Healthy Participants - Full Text View

Sponsors and Collaborators:	University of Illinois National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00322114

Purpose

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.

Condition	Intervention
Prostate Cancer	Drug: lycopene Drug: placebo

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Placebo Control
Official Title:	Mechanism of Prostate Cancer Prevention by Lycopene

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	February 2006
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.	Drug: lycopene Given orally
Arm II: Experimental Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.	Drug: lycopene Given orally
Arm III: Placebo Comparator Participants receive oral placebo twice daily for 3 weeks.	Drug: placebo Given orally

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322114

Locations

United States, Illinois
University of Illinois Cancer Center	Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046

Sponsors and Collaborators

University of Illinois

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Richard B. van Breemen, PhD

University of Illinois

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000468031, UIC-2004-0217
Study First Received:	May 3, 2006
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00322114
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Lycopene
Urogenital Neoplasms

Healthy
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anticarcinogenic Agents
Radiation-Protective Agents
Neoplasms
Antioxidants
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009