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The Effects of Lycopene on High Risk Prostatic Tissue

NCT01443026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-11-19

Study results available
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Summary

The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

Conditions

  • Intraepithelial Prostatic Neoplasia
  • Prostatic Neoplasms

Interventions

DRUG

Lycopene 30mg

Lycopene 30 mg.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Peter H Gann, MD, ScD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443026 on ClinicalTrials.gov