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Lycopene for Preventing Prostate Cancer

Waitlist Available
Led By Richard B. van Breemen, PhD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to supply blood and urine samples
No existing prostate disease
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying whether the supplement lycopene can prevent prostate cancer.

Who is the study for?
This trial is for healthy men who don't abuse alcohol or drugs, have no prostate disease or cancer, and aren't allergic to tomatoes. They must not be in the hospital, able to give blood and urine samples, and willing to answer health and diet questionnaires. Men already taking lycopene supplements or in another trial can't join.Check my eligibility
What is being tested?
The study is testing if lycopene (a substance from tomatoes) can prevent prostate cancer when compared with a placebo (a harmless pill). Participants will be randomly assigned to receive either lycopene or the placebo without knowing which one they are getting.See study design
What are the potential side effects?
Lycopene is generally considered safe but may cause digestive issues like bloating, indigestion, nausea, diarrhea; skin discoloration; and allergies in those sensitive to tomatoes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I can provide blood and urine samples for testing.
I do not have any prostate disease.
I do not have any gastrointestinal diseases or cancer.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene

Side effects data

From 2014 Phase 4 trial • 28 Patients • NCT02587117
Increased appetite
Abdominal distension
Study treatment Arm
Lycopene Group
Prednisolone Group

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IIExperimental Treatment1 Intervention
Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
Group II: Arm IExperimental Treatment1 Intervention
Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
Group III: Arm IIIPlacebo Group1 Intervention
Participants receive oral placebo twice daily for 3 weeks.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
595 Previous Clinical Trials
1,557,284 Total Patients Enrolled
9 Trials studying Prostate Cancer
858 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,565 Previous Clinical Trials
41,223,650 Total Patients Enrolled
558 Trials studying Prostate Cancer
506,128 Patients Enrolled for Prostate Cancer
Richard B. van Breemen, PhDPrincipal InvestigatorUniversity of Illinois at Chicago
1 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Prostate Cancer
120 Patients Enrolled for Prostate Cancer

Media Library

Lycopene (Carotenoid) Clinical Trial Eligibility Overview. Trial Name: NCT00322114 — N/A
Prostate Cancer Research Study Groups: Arm I, Arm II, Arm III
Prostate Cancer Clinical Trial 2023: Lycopene Highlights & Side Effects. Trial Name: NCT00322114 — N/A
Lycopene (Carotenoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00322114 — N/A
Prostate Cancer Patient Testimony for trial: Trial Name: NCT00322114 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial still open?

"As per clinicaltrials.gov, this medical study is not presently accepting new participants; the trial having been initiated on February 1st 2006 and modified lastly on September 19th 2013. However, 1322 other trials are actively recruiting patients right now."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
University of Illinois Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I have recurrent prostate cancer. The current plan is to continue with bicalutamide (50 mg/day), aerobic and resistance training and watch the PSA. I am interested in other treatment which may slow or prevent the spread of my condition. My oncologist is on board with investigating the possibility of being included in this study.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Are travel related expenses covered?
PatientReceived 1 prior treatment
~8 spots leftby Feb 2025