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Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation (PBroC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265953
First Posted: December 23, 2010
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Oregon State University
OHSU Knight Cancer Institute
Information provided by (Responsible Party):
Jackilen Shannon, Portland VA Medical Center
Results First Submitted: May 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: Prostate Cancer Prevention
Interventions: Drug: sulforaphane glucosinolate capsules
Dietary Supplement: Gelatin capsule containing cellulose and magnesium stearate

  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
Supplement Subjects in this group were administered with broccoli sprout extract.
Placebo Subjects in this group were administered with placebo.

Participant Flow:   Overall Study
    Supplement   Placebo
STARTED   50   48 
COMPLETED   45   45 
NOT COMPLETED   5   3 
Non compliance                5                3 



  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.
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Reporting Groups
  Description
Sulforaphane Glucosinolate Capsules

Four weeks sulforaphane (SFN) glucosinolate capsules: 250 mg of broccoli seed extract (30 mg sulforaphane glucosinolate), 8 capsules (4 capsules B.I.D.) daily

sulforaphane glucosinolate capsules: Four weeks sulforaphane (SFN) glucosinolate capsules: 250 mg of broccoli seed extract (30 mg sulforaphane glucosinolate), 8 capsules (4 capsules B.I.D.) daily

Placebo Capsules

Four weeks placebo capsules: 8 capsules (4 capsules B.I.D.) daily

Gelatin capsule containing cellulose and magnesium stearate: Four weeks placebo: 8 capsules (4 capsules B.I.D.) daily

Total Total of all reporting groups

Baseline Measures
   Sulforaphane Glucosinolate Capsules   Placebo Capsules   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   48   98 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.7  (5.4)   64.9  (5.0)   65.3  (5.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      50 100.0%      48 100.0%      98 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   2.0%      1   2.1%      2   2.0% 
White      48  96.0%      46  95.8%      94  95.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   2.0%      1   2.1%      2   2.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   50   48   98 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.9  (7.6)   31.1  (6.4)   30.0  (7.1) 


  Outcome Measures
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1.  Primary:   Change of Total Urine SFN (Sulforaphane) Metabolites   [ Time Frame: minimum 4 to maximum 8 weeks ]

2.  Primary:   Change of Total Plasma SFN (Sulforaphane) Metabolites Level   [ Time Frame: minimum 4 to maximum 8 weeks ]

3.  Primary:   Expression of Ki67   [ Time Frame: minimum 4 to maximum 8 weeks; prostate biopsy were collected post-intervention when clinically-indicated ]

4.  Primary:   Expression of Histone Deacetylase 6 (HDAC6)   [ Time Frame: minimum 4 to maximum 8 weeks; prostate biopsy were collected post-intervention when clinically-indicated ]


  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.Jackilen Shannon
Organization: Oregon Health & Science University
phone: 503-418-9860
e-mail: shannoja@ohsu.edu



Responsible Party: Jackilen Shannon, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT01265953     History of Changes
Other Study ID Numbers: Portland VA-09-0607
2096 ( Other Identifier: PVAMC IRB )
6232 ( Other Identifier: OHSU IRB )
2P01CA090890-06A2 ( U.S. NIH Grant/Contract )
First Submitted: December 16, 2010
First Posted: December 23, 2010
Results First Submitted: May 12, 2017
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017