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The Effects of Lycopene on High Risk Prostatic Tissue

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ClinicalTrials.gov Identifier: NCT01443026
Recruitment Status : Completed
First Posted : September 29, 2011
Results First Posted : June 4, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Intraepithelial Prostatic Neoplasia
Prostatic Neoplasms
Interventions Drug: Lycopene 30mg
Drug: Placebo
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lycopene Placebo
Hide Arm/Group Description

Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)

Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)

Period Title: Overall Study
Started 29 37
Completed 26 32
Not Completed 3 5
Reason Not Completed
Physician Decision             1             0
Death             0             1
Withdrawal by Subject             0             3
Lost to Follow-up             2             1
Arm/Group Title Lycopene Placebo Total
Hide Arm/Group Description Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) Total of all reporting groups
Overall Number of Baseline Participants 26 32 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 32 participants 58 participants
62.9  (8.3) 67.1  (8.1) 65.2  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 32 participants 58 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
26
 100.0%
32
 100.0%
58
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 32 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.8%
0
   0.0%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  23.1%
9
  28.1%
15
  25.9%
White
19
  73.1%
23
  71.9%
42
  72.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 32 participants 58 participants
26 32 58
1.Primary Outcome
Title Tissue Biomarkers
Hide Description We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.
Time Frame baseline and 6 months
Outcome Measure Data Not Reported
2.Primary Outcome
Title Changes in Serum Biomarkers
Hide Description Change in serum lycopene, umol/L
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lycopene Placebo
Hide Arm/Group Description:
Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Overall Number of Participants Analyzed 26 32
Mean (Full Range)
Unit of Measure: umol/L
.55
(-0.7 to 1.6)
-0.29
(-1.1 to 0.6)
3.Secondary Outcome
Title Changes in Nuclear Morphometry
Hide Description We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.
Time Frame baseline and 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lycopene Placebo
Hide Arm/Group Description Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
All-Cause Mortality
Lycopene Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lycopene Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      1/32 (3.13%)    
Cardiac disorders     
death [1]  0/26 (0.00%)  0 1/32 (3.13%)  1
[1]
Patient died four days after randomization from CAD. Patient was on placebo. Event was unrelated to study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lycopene Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      1/32 (3.13%)    
Gastrointestinal disorders     
constipation  0/26 (0.00%)  0 1/32 (3.13%)  1
Renal and urinary disorders     
increased urinary frequency  0/26 (0.00%)  0 1/32 (3.13%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Peter Gann
Organization: University of Illinois at Chicago
Phone: 312-355-3723
EMail: pgann@uic.edu
Responsible Party: Peter Gann, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01443026     History of Changes
Other Study ID Numbers: 2005-0828
R01CA090759 ( U.S. NIH Grant/Contract )
First Submitted: September 27, 2011
First Posted: September 29, 2011
Results First Submitted: April 17, 2014
Results First Posted: June 4, 2015
Last Update Posted: November 6, 2017