A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carotenoids; Lycopene

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