Clinical Trial: The Effects of Lycopene on High Risk Prostatic Tissue

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: University of Illinois at Chicago

Current Primary Outcome:

  • 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.
  • Changes in Serum Biomarkers [ Time Frame: baseline and 6 months ]
    Change in serum lycopene, umol/L


Original Primary Outcome: 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.


Current Secondary Outcome: 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.


Original Secondary Outcome:

  • 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.
  • Changes in serum biomarkers [ Time Frame: baseline and 6 months ]


Information By: University of Illinois at Chicago

Dates:
Date Received: September 27, 2011
Date Started: February 2006
Date Completion:
Last Updated: December 1, 2015
Last Verified: December 2015