The Effects of Lycopene on High Risk Prostatic Tissue

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01443026
First received: September 27, 2011
Last updated: June 2, 2015
Last verified: June 2015
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Intraepithelial Prostatic Neoplasia
Prostatic Neoplasms
Intervention: Drug: Lycopene 30 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lycopene

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

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)


Participant Flow:   Overall Study
    Lycopene     Placebo  
STARTED     29     37  
COMPLETED     26     32  
NOT COMPLETED     3     5  
Physician Decision                 1                 0  
Death                 0                 1  
Withdrawal by Subject                 0                 3  
Lost to Follow-up                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lycopene Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
Placebo Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
Total Total of all reporting groups

Baseline Measures
    Lycopene     Placebo     Total  
Number of Participants  
[units: participants]
  26     32     58  
Age  
[units: years]
Mean (Standard Deviation)
  62.9  (8.3)     67.1  (8.1)     65.2  (8.4)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     26     32     58  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     9     15  
White     19     23     42  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     26     32     58  



  Outcome Measures

1.  Primary:   Changes in Serum Biomarkers   [ Time Frame: baseline and 6 months ]

2.  Primary:   Tissue Biomarkers   [ Time Frame: baseline and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Changes in Nuclear Morphometry   [ Time Frame: baseline and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: pgann@uic.edu


Publications:

Responsible Party: Peter Gann, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01443026     History of Changes
Other Study ID Numbers: 2005-0828, R01CA090759
Study First Received: September 27, 2011
Results First Received: April 17, 2014
Last Updated: June 2, 2015
Health Authority: United States: Food and Drug Administration