Your session is about to expire
← Back to Search
Carotenoid
Lycopene for Preventing Prostate Cancer
N/A
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
No existing gastrointestinal disease or cancer
No existing prostate disease
Timeline
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 belowSelect...
I do not have any gastrointestinal diseases or cancer.
Select...
I do not have any prostate disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 • NCT0258711769%
Flatulency
31%
Nausea
23%
Increased appetite
15%
Abdominal distension
15%
Diarrhea
8%
Headache
8%
Dizziness
100%
80%
60%
40%
20%
0%
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lycopene
2008
Completed Phase 4
~260
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,206 Total Patients Enrolled
9 Trials studying Prostate Cancer
858 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,003 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,023 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide blood and urine samples for testing.I do not have any gastrointestinal diseases or cancer.I haven't taken lycopene supplements in the last 2 weeks.I do not have any prostate disease.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II
- Group 3: Arm III
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
1
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
Recent research and studies
Share this study with friends
Copy Link
Messenger