search
Back to results

The Effects of Lycopene on High Risk Prostatic Tissue

Primary Purpose

Intraepithelial Prostatic Neoplasia, Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lycopene 30mg
Placebo
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraepithelial Prostatic Neoplasia focused on measuring Intraepithelial Prostatic Neoplasia, Prostatic neoplasms, Male urogenital disease, Prostate

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Memorial Hospital
  • Jesse Brown VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lycopene

Placebo

Arm Description

Lycopene 30 mg/day

Placebo

Outcomes

Primary Outcome Measures

Tissue Biomarkers
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
Change in serum lycopene, umol/L

Secondary Outcome Measures

Changes in Nuclear Morphometry
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.

Full Information

First Posted
September 27, 2011
Last Updated
November 15, 2019
Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01443026
Brief Title
The Effects of Lycopene on High Risk Prostatic Tissue
Official Title
R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraepithelial Prostatic Neoplasia, Prostatic Neoplasms
Keywords
Intraepithelial Prostatic Neoplasia, Prostatic neoplasms, Male urogenital disease, Prostate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lycopene
Arm Type
Experimental
Arm Description
Lycopene 30 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Lycopene 30mg
Other Intervention Name(s)
Lyco-Mato
Intervention Description
Lycopene 30 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Tissue Biomarkers
Description
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.
Time Frame
baseline and 6 months
Title
Changes in Serum Biomarkers
Description
Change in serum lycopene, umol/L
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Changes in Nuclear Morphometry
Description
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.
Time Frame
baseline and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Gann, MD, ScD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Jesse Brown VA Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8896894
Citation
Clinton SK, Emenhiser C, Schwartz SJ, Bostwick DG, Williams AW, Moore BJ, Erdman JW Jr. cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol Biomarkers Prev. 1996 Oct;5(10):823-33.
Results Reference
background
PubMed Identifier
9784387
Citation
Pastori M, Pfander H, Boscoboinik D, Azzi A. Lycopene in association with alpha-tocopherol inhibits at physiological concentrations proliferation of prostate carcinoma cells. Biochem Biophys Res Commun. 1998 Sep 29;250(3):582-5. doi: 10.1006/bbrc.1998.9351.
Results Reference
background
PubMed Identifier
10050865
Citation
Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. doi: 10.1093/jnci/91.4.317.
Results Reference
background
PubMed Identifier
10578485
Citation
Jain MG, Hislop GT, Howe GR, Ghadirian P. Plant foods, antioxidants, and prostate cancer risk: findings from case-control studies in Canada. Nutr Cancer. 1999;34(2):173-84. doi: 10.1207/S15327914NC3402_8.
Results Reference
background
PubMed Identifier
7473833
Citation
Giovannucci E, Ascherio A, Rimm EB, Stampfer MJ, Colditz GA, Willett WC. Intake of carotenoids and retinol in relation to risk of prostate cancer. J Natl Cancer Inst. 1995 Dec 6;87(23):1767-76. doi: 10.1093/jnci/87.23.1767.
Results Reference
background
PubMed Identifier
9806659
Citation
Bostwick DG, Shan A, Qian J, Darson M, Maihle NJ, Jenkins RB, Cheng L. Independent origin of multiple foci of prostatic intraepithelial neoplasia: comparison with matched foci of prostate carcinoma. Cancer. 1998 Nov 1;83(9):1995-2002. doi: 10.1002/(sici)1097-0142(19981101)83:93.0.co;2-2.
Results Reference
background
PubMed Identifier
632120
Citation
Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. No abstract available. German.
Results Reference
background

Learn more about this trial

The Effects of Lycopene on High Risk Prostatic Tissue

We'll reach out to this number within 24 hrs