A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00178113
First received: September 13, 2005
Last updated: January 3, 2008
Last verified: January 2008
  Purpose

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).


Condition Intervention Phase
Prostatic Intraepithelial Neoplasia
Drug: - Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)
Drug: - Certagen (multivitamins with minerals)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Serum PSA at randomization, one month, four months

Secondary Outcome Measures:
  • Serum lycopene at randomization, one month, four months

Estimated Enrollment: 80
Study Start Date: July 2003
Estimated Study Completion Date: July 2004
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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178113

Locations
Trinidad and Tobago
Tobago Prostate Survey Office
Scarborough, Tobago, Trinidad and Tobago
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Clareann H Bunker, PhD University of Pittsburgh
Study Director: Lewis H Kuller, MD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00178113     History of Changes
Other Study ID Numbers: R01CA084950-05S1, P200202-134PRC02-134
Study First Received: September 13, 2005
Last Updated: January 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Prostatic Intraepithelial Neoplasia
Prostate-Specific Antigen
lycopene

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Prostatic Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014