The Effects of Lycopene on High Risk Prostatic Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01443026
Recruitment Status : Completed
First Posted : September 29, 2011
Results First Posted : June 4, 2015
Last Update Posted : November 6, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Intraepithelial Prostatic Neoplasia Prostatic Neoplasms Drug: Lycopene 30mg Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue
Study Start Date : February 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

Arm Intervention/treatment
Experimental: Lycopene
Lycopene 30 mg/day
Drug: Lycopene 30mg
Lycopene 30 mg.
Other Name: Lyco-Mato

Placebo Comparator: Placebo
Drug: Placebo
Other Name: Sugar Pill

Primary Outcome Measures :
  1. 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.

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

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01443026

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Cancer Institute (NCI)
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago

Responsible Party: Peter Gann, Professor and Director, Division of Pathology Research, University of Illinois at Chicago Identifier: NCT01443026     History of Changes
Other Study ID Numbers: 2005-0828
R01CA090759 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2011    Key Record Dates
Results First Posted: June 4, 2015
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Peter Gann, University of Illinois at Chicago:
Intraepithelial Prostatic Neoplasia
Prostatic neoplasms
Male urogenital disease

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Intraepithelial Neoplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents