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

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ClinicalTrials.gov Identifier: NCT01265953
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : July 14, 2017
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Oregon State University
OHSU Knight Cancer Institute
Information provided by (Responsible Party):
Jackilen Shannon, Portland VA Medical Center

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: SFN-rich broccoli sprout extract capsules
Dietary Supplement: Gelatin capsule containing microcrystalline cellulose.
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Supplement Placebo
Hide Arm/Group Description Subjects in this group were administered with broccoli sprout extract. Subjects in this group were administered with placebo.
Period Title: Overall Study
Started 50 48
Completed 45 45
Not Completed 5 3
Reason Not Completed
Non compliance             5             3
Arm/Group Title Broccoli Sprout Extract Capsules Placebo Capsules Total
Hide Arm/Group Description Four weeks broccoli sprout extract (BSE) capsules: 200µmol of sulforaphane (SFN) daily, 2 capsules (1 capsule B.I.D.) daily

Four weeks placebo capsules: 2 capsules (1 capsule B.I.D.) daily

Dietary Supplement: Gelatin capsule containing microcrystalline cellulose

Total of all reporting groups
Overall Number of Baseline Participants 50 48 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 98 participants
65.7  (5.4) 64.9  (5.0) 65.3  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
50
 100.0%
48
 100.0%
98
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 98 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants 48 participants 98 participants
50
 100.0%
48
 100.0%
98
 100.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 50 participants 48 participants 98 participants
28.9  (7.6) 31.1  (6.4) 30.0  (7.1)
1.Primary Outcome
Title Change of Total Urine SFN (Sulforaphane) Metabolites
Hide Description Collection of blood and urine specimens occurred at pre-intervention and post-intervention. Change = post-intervention level minus pre-intervention level
Time Frame Baseline and 4-8 weeks following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects had urine samples for analysis, therefore, the total number of subjects in this urine analysis is different from total number of enrolled subjects.
Arm/Group Title Supplement Placebo
Hide Arm/Group Description:
Subjects in this group were administered with broccoli sprout extract.
Subjects in this group were administered with placebo.
Overall Number of Participants Analyzed 42 44
Mean (Standard Error)
Unit of Measure: micromolar (µM) concentrations of urina
4.75  (0.64) -0.02  (0.01)
2.Primary Outcome
Title Change of Total Plasma SFN (Sulforaphane) Metabolites Level
Hide Description In subjects at risk for prostate cancer, presence of SFN was analyzed in plasma. Collection of blood specimens occurred at pre-intervention and post-intervention. The Change = post-intervention level minus pre-intervention level
Time Frame Baseline and 4-8 weeks following intervention
Hide Outcome Measure Data
Hide Analysis Population Description
We missed blood samples from some subjects, therefore, total number of subjects analyzed for the plasma-based analysis is different from the number of total enrolled subjects.
Arm/Group Title Supplement Placebo
Hide Arm/Group Description:
Subjects in this group were administered with broccoli sprout extract.
Subjects in this group were administered with placebo.
Overall Number of Participants Analyzed 42 44
Mean (Standard Error)
Unit of Measure: micromolar (µM)
0.12  (0.03) -0.0003  (0.0002)
3.Primary Outcome
Title Percentage of Ki67 Positive Cells up to 8 Weeks Post-randomization
Hide Description Ki67 is a biomarker of disease progression. Immunohistochemical (IHC) analysis of Ki67 was performed using research only prostate biopsy specimens collected post-intervention at the time of the clinically-indicated prostate biopsy.
Time Frame Baseline and 4-8 weeks following intervention; prostate biopsy were collected post-intervention when clinically-indicated
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects did not have post-intervention prostate tissue that can be used for IHC analysis, therefore, the overall number of participants analyzed for IHC analysis is different from the total enrolled subjects.
Arm/Group Title Supplement Placebo
Hide Arm/Group Description:
Subjects in this group were administered with broccoli sprout extract.
Subjects in this group were administered with placebo.
Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: percent positive
1.8  (0.2) 1.9  (0.3)
4.Primary Outcome
Title Expression of Histone Deacetylase 6 (HDAC6)
Hide Description Immunohistochemical (IHC) analysis of HDAC6 expression using research-only prostate biopsy tissue collected post-intervention at the time of the clinically-indicated prostate biopsy. A modified Histo-score (H-score) was calculated, which involved semiquantitative assessment of both staining intensity (graded as 1-3 with 1 representing weak staining, 2 moderate, and 3 strong) and percentage of positive cells. H-score ranged from 0 to 300 with 300 the strongest expression.
Time Frame Baseline and 4-8 weeks following intervention; prostate biopsy were collected post-intervention when clinically-indicated
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects did not have post-intervention prostate tissue that can be used for IHC analysis, therefore, the overall number of participants analyzed for IHC analysis is different from the total enrolled subjects.
Arm/Group Title Supplement Placebo
Hide Arm/Group Description:
Subjects in this group were administered with broccoli sprout extract.
Subjects in this group were administered with placebo.
Overall Number of Participants Analyzed 41 42
Mean (Standard Error)
Unit of Measure: H-score
187  (13) 183  (12.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Supplement Placebo
Hide Arm/Group Description Subjects in this group were administered with broccoli sprout extract. Subjects in this group were administered with placebo.
All-Cause Mortality
Supplement Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/48 (0.00%)    
Hide Serious Adverse Events
Supplement Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/48 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Supplement Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      1/48 (2.08%)    
Gastrointestinal disorders     
Bloating *  1/50 (2.00%)  1 0/48 (0.00%)  0
Nervous system disorders     
Headache *  1/50 (2.00%)  1 0/48 (0.00%)  0
Taste Alteration *  0/50 (0.00%)  0 1/48 (2.08%)  1
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr.Jackilen Shannon
Organization: Oregon Health & Science University
Phone: 503-418-9860
EMail: shannoja@ohsu.edu
Layout table for additonal information
Responsible Party: Jackilen Shannon, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT01265953    
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: May 1, 2019