Status:
COMPLETED
A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostatic Intraepithelial Neoplasia
Eligibility:
MALE
40-79 years
Phase:
PHASE1
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 me...
Eligibility Criteria
Inclusion
- biopsy reported high grade prostatic intraepithelial neoplasia
- and/or biopsy reported atypia
- and/or persistently elevated serum prostate specific antigen with normal biopsy
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00178113
Start Date
July 1 2003
End Date
July 1 2004
Last Update
May 27 2015
Active Locations (1)
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1
Tobago Prostate Survey Office
Scarborough, Tobago, Trinidad and Tobago