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Completed

NCT Number: NCT00178113

A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

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).

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Key information

Conditions

Prostatic Intraepithelial Neoplasia Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

40 year–79 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tobago Prostate Survey Office

Scarborough, Tobago, Trinidad and Tobago

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

- Certagen (multivitamins with minerals)

Drug

Primary outcomes

  1. Serum PSA at randomization, one month, four months

Secondary outcomes

  1. Serum lycopene at randomization, one month, four months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Sep 15, 2005
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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