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Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

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.
 
ClinicalTrials.gov Identifier: NCT00946309
Recruitment Status : Completed
First Posted : July 27, 2009
Results First Posted : November 15, 2016
Last Update Posted : November 15, 2016
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

Tracking Information
First Submitted Date  ICMJE July 23, 2009
First Posted Date  ICMJE July 27, 2009
Results First Submitted Date  ICMJE August 20, 2015
Results First Posted Date  ICMJE November 15, 2016
Last Update Posted Date November 15, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2016)
  • Gene Expression of Phase II Enzymes [ Time Frame: Baseline and 5 weeks ]
    Change in Phase II enzyme expression
  • Lipid Oxidation [ Time Frame: Baseline and 5 weeks ]
    Blood F2 Isoprostane levels
  • DNA Oxidation [ Time Frame: Five weeks ]
    Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
  • DHT Levels [ Time Frame: Baseline and 5 weeks ]
    Change in serum dihydrotestosterone (DHT) levels
  • Testosterone Levels [ Time Frame: Baseline and 5 weeks ]
    Change in testosterone (T) levels
  • 3-alpha-diol Gluconate Levels [ Time Frame: Baseline and 5 weeks ]
    Change in serum 3-alpha-diol gluconate(3α-DG) levels
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2009)
tissue F2isoprostanes [ Time Frame: baseline and 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Sulforaphane on Normal Prostate Tissue
Official Title  ICMJE In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
Brief Summary

The investigators proposed to identify the biological effects of a high-sulforaphane broccoli sprout extract in normal prostate tissue.

The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
    100 umol sulforaphane, every other day for 5 weeks
    Other Name: Broccoli Sprout Extract
  • Drug: Microcrystalline Cellulose NF (placebo)
    250 mg every other day for 6 weeks
Study Arms  ICMJE
  • Experimental: High Sulforaphane Extract
    Intervention: Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
  • Placebo Comparator: Placebo
    Intervention: Drug: Microcrystalline Cellulose NF (placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2016)
45
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2009)
100
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men aged 40-75 years
  • Low or intermediate grade prostate cancer (as defined by Gleason sum less than or equal to 7) and clinical stage T1 or T2
  • Serum Prostate specific antigen less than 20 ng/ml
  • Have elected radical prostatectomy, Brachytherapy or active surveillance as their primary treatment

Exclusion Criteria:

  • No current physician diagnosed disease (including but not limited to): kidney disease requiring dialysis, cognitive deficits, substance abuse
  • BMI < 18.5 kg/m2 or > 40 kg/m2
  • Use of any hormonal treatments, including but not limited to testosterone
  • Any previous cancer diagnosis or treatment within the previous five years, excluding non-melanoma skin cancer
  • Inability or unwillingness to eat a diet that is free of Brassica vegetables for the duration of the study
  • Use of any dietary supplements other than a multivitamin (including herbal preparations)
  • Allergy to cruciferous vegetables or any of the specific fillers used in the placebo
  • Usual consumption of > 5 servings per week of Brassica vegetables
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00946309
Other Study ID Numbers  ICMJE PHS 2333.00
6969 ( Other Identifier: FHCRC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Lin, Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • VA Puget Sound Health Care System
  • Seattle Institute for Biomedical and Clinical Research
  • Johns Hopkins University
  • University of Washington
  • Cedars-Sinai Medical Center
Investigators  ICMJE
Principal Investigator: Daniel W Lin, MD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP