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Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

This study has been completed.
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Johns Hopkins University
University of Washington
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Daniel Lin, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00946309
First received: July 23, 2009
Last updated: September 24, 2016
Last verified: June 2016
Results First Received: August 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Prostate Cancer
Interventions: Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
Drug: Microcrystalline Cellulose NF (placebo)

  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
Recruitment occurred from July 2010 to April 2014 at the VA Puget Sound Health Care System.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no pre-assignment events. Group assignment occurred at the time of participant enrollment.

Reporting Groups
  Description
Sulforaphane High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Placebo Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks

Participant Flow:   Overall Study
    Sulforaphane   Placebo
STARTED   22   23 
COMPLETED   21   19 
NOT COMPLETED   1   4 
Protocol Violation                1                0 
Lost to Follow-up                0                1 
Procedure cancelled/discontinued                0                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.
One participant enrolled to the placebo arm was determined to be ineligible, and was withdrawn from the study Two additional participants enrolled to the placebo arm became ineligible after enrollment, and were withdrawn from the study

Reporting Groups
  Description
Sulforaphane High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
Placebo Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
Total Total of all reporting groups

Baseline Measures
   Sulforaphane   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   23   45 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   17   29 
>=65 years   10   6   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.6  (5.4)   62.8  (4.3)   62.7  (4.8) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   22   23   45 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   0   1   1 
Not Hispanic or Latino   22   22   44 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   4   3   7 
White   16   20   36 
More than one race   1   0   1 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   22   23   45 


  Outcome Measures
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1.  Primary:   Gene Expression of Phase II Enzymes   [ Time Frame: Baseline and 5 weeks ]

2.  Primary:   Lipid Oxidation   [ Time Frame: Baseline and 5 weeks ]

3.  Primary:   DNA Oxidation   [ Time Frame: Five weeks ]

4.  Primary:   DHT Levels   [ Time Frame: Baseline and 5 weeks ]

5.  Primary:   Testosterone Levels   [ Time Frame: Baseline and 5 weeks ]

6.  Primary:   3-alpha-diol Gluconate Levels   [ Time Frame: Baseline and 5 weeks ]


  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. Daniel Lin
Organization: Fred Hutchinson Cancer Research Center
phone: 206-221-0797
e-mail: dwlin@uw.edu



Responsible Party: Daniel Lin, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00946309     History of Changes
Other Study ID Numbers: PHS 2333.00
6969 ( Other Identifier: FHCRC )
Study First Received: July 23, 2009
Results First Received: August 20, 2015
Last Updated: September 24, 2016
Health Authority: United States: Food and Drug Administration