Back to resultsA Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
Primary Purpose
Prostatic Intraepithelial Neoplasia
Status
Completed
Phase
Phase 1
Locations
Trinidad and Tobago
Study Type
Interventional
Intervention
- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)
- Certagen (multivitamins with minerals)
Sponsored by
About this trial
This is an interventional prevention trial for Prostatic Intraepithelial Neoplasia focused on measuring Prostatic Intraepithelial Neoplasia, Prostate-Specific Antigen, lycopene
Eligibility Criteria
Inclusion Criteria: biopsy reported high grade prostatic intraepithelial neoplasia and/or biopsy reported atypia and/or persistently elevated serum prostate specific antigen with normal biopsy Exclusion Criteria: biopsy diagnosed prostate cancer serum prostate specific antigen > 40 ng/ml hospitalization in past six months history of allergy to tomatoes history of allergic dermatitis serious concurrent illness inability to provide informed consent
Sites / Locations
- Tobago Prostate Survey Office
Outcomes
Primary Outcome Measures
Serum PSA at randomization, one month, four months
Secondary Outcome Measures
Serum lycopene at randomization, one month, four months
Full Information
NCT ID
NCT00178113
First Posted
September 13, 2005
Last Updated
May 26, 2015
Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00178113
Brief Title
A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
Official Title
Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).
Detailed Description
Observational studies suggest higher lycopene intake or higher lycopene blood levels are associated with a lower risk for prostate cancer. Two recent trials of lycopene supplementation conducted in men with prostate cancer, during the three weeks prior to radical prostatectomy, found a reduction in serum PSA suggesting a regression of prostate cancer.
High grade intraepithelial neoplasia (HGPIN)is thought to be a precancerous lesion, and men with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy. The objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA)over four months of supplementation. Serum PSA is compared in men randomized to 30 mg/day lycopene plus a standard multivitamin versus standard multivitamin alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Intraepithelial Neoplasia
Keywords
Prostatic Intraepithelial Neoplasia, Prostate-Specific Antigen, lycopene
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)
Intervention Type
Drug
Intervention Name(s)
- Certagen (multivitamins with minerals)
Primary Outcome Measure Information:
Title
Serum PSA at randomization, one month, four months
Secondary Outcome Measure Information:
Title
Serum lycopene at randomization, one month, four months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
biopsy reported high grade prostatic intraepithelial neoplasia
and/or biopsy reported atypia
and/or persistently elevated serum prostate specific antigen with normal biopsy
Exclusion Criteria:
biopsy diagnosed prostate cancer
serum prostate specific antigen > 40 ng/ml
hospitalization in past six months
history of allergy to tomatoes
history of allergic dermatitis
serious concurrent illness
inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clareann H Bunker, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lewis H Kuller, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
Tobago Prostate Survey Office
City
Scarborough
State/Province
Tobago
Country
Trinidad and Tobago
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
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