The Effects of Lycopene on High Risk Prostatic Tissue

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Gann, University of Illinois
ClinicalTrials.gov Identifier:
NCT01443026
First received: September 27, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

September 27, 2011
September 27, 2011
February 2006
April 2009   (final data collection date for primary outcome measure)
Tissue Biomarkers [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
  • Changes in nuclear morphometry [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Lycopene on High Risk Prostatic Tissue
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Intraepithelial Prostatic Neoplasia
  • Prostatic Neoplasms
Drug: Lycopene 30 mg or Placebo
Taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Other Name: Lyc-O-Mato
  • Experimental: Lycopene
    Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
    Intervention: Drug: Lycopene 30 mg or Placebo
  • Placebo Comparator: Placebo
    Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
    Intervention: Drug: Lycopene 30 mg or Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01443026
2005-0828, R01CA090759
No
Peter Gann, University of Illinois
University of Illinois at Chicago
National Cancer Institute (NCI)
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
University of Illinois at Chicago
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP