A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178113
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 27, 2015
National Cancer Institute (NCI)
Information provided by:
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).

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

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 Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
Study Start Date : July 2003
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178113

Trinidad and Tobago
Tobago Prostate Survey Office
Scarborough, Tobago, Trinidad and Tobago
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
Principal Investigator: Clareann H Bunker, PhD University of Pittsburgh
Study Director: Lewis H Kuller, MD University of Pittsburgh Identifier: NCT00178113     History of Changes
Other Study ID Numbers: R01CA084950-05S1 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

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

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