A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

Prostatic Intraepithelial Neoplasia Clinical Trial

Official title:

Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178113
• Other study ID #: R01CA084950-05S1
• Secondary ID: P200202-134PRC02
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: May 26, 2015
• Start date: July 2003
• Est. completion date: July 2004

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Neoplasms
• Prostatic Intraepithelial Neoplasia

Intervention

Drug:
• - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)

• - Certagen (multivitamins with minerals)

Locations

Country	Name	City	State
Trinidad and Tobago	Tobago Prostate Survey Office	Scarborough	Tobago

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

Trinidad and Tobago, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum PSA at randomization, one month, four months
Secondary	Serum lycopene at randomization, one month, four months