A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

Phase 1

Completed

• Conditions: Prostatic Intraepithelial Neoplasia

• Registration Number: NCT00178113
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2003-07
• Study Completion: 2004-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum PSA at randomization, one month, four months

Secondary Outcome Measures

Name	Time	Method
Serum lycopene at randomization, one month, four months

Trial Locations

Locations (1)

Tobago Prostate Survey Office; 🇹🇹 Scarborough, Tobago, Trinidad and Tobago