The Effects of Lycopene on High Risk Prostatic Tissue

November 15, 2019 updated by: Peter Gann, University of Illinois at Chicago

R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue

The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

Study Overview

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
  • Have an AUA symptom score <=25 at time of registration.
  • Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
  • Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
  • Be willing to limit intake of lycopene-containing foods while on study
  • Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
  • Be ambulatory, capable of self-care and able to carry out light or sedentary work
  • Have a dietary fat intake of 23-48% of calories
  • Participant's physician recommends repeat biopsy 4-6 months after randomization

Exclusion Criteria:

  • No repeat biopsy planned
  • Not willing to change diet
  • Have a diagnosis of prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo
Other Names:
  • Sugar Pill
Experimental: Lycopene
Lycopene 30 mg/day
Lycopene 30 mg.
Other Names:
  • Lyco-Mato

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Biomarkers
Time Frame: baseline and 6 months
We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.
baseline and 6 months
Changes in Serum Biomarkers
Time Frame: baseline and 6 months
Change in serum lycopene, umol/L
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Nuclear Morphometry
Time Frame: baseline and 6 months
We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Peter H Gann, MD, ScD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Actual)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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