A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00178113

Enrollment

Registered

2005-09-15

Start date

2003-07-31

Completion date

2004-07-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Intraepithelial Neoplasia

Keywords

Prostatic Intraepithelial Neoplasia, Prostate-Specific Antigen, lycopene

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.

Interventions

DRUG- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)

DRUG- Certagen (multivitamins with minerals)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Serum PSA at randomization, one month, four months	—

Secondary

Measure	Time frame
Serum lycopene at randomization, one month, four months	—

Countries

Trinidad and Tobago

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026