NCT00178113

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

First QC Date

September 13, 2005

Last Update Submit

May 26, 2015

Conditions

Prostatic Intraepithelial Neoplasia

Keywords

Prostatic Intraepithelial NeoplasiaProstate-Specific Antigenlycopene

Outcome Measures

Primary Outcomes (1)

  • Serum PSA at randomization, one month, four months

Secondary Outcomes (1)

  • Serum lycopene at randomization, one month, four months

Interventions

- Lyc-O-Mato (dietary supplement, 30 mg lycopene/day)DRUG
- Certagen (multivitamins with minerals)DRUG

Eligibility Criteria

Age40 Years - 79 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • biopsy reported high grade prostatic intraepithelial neoplasia
  • and/or biopsy reported atypia
  • and/or persistently elevated serum prostate specific antigen with normal biopsy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tobago Prostate Survey Office

Scarborough, Tobago, Trinidad and Tobago

Location

MeSH Terms

Conditions

Prostatic Intraepithelial Neoplasia

Interventions

LycopeneDietary SupplementsGeritolMinerals

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological FactorsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesInorganic Chemicals

Study Officials

  • Clareann H Bunker, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Lewis H Kuller, MD

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

July 1, 2003

Study Completion

July 1, 2004

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

TR(1)