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Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

This study is enrolling participants by invitation only.
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):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00946309
First received: July 23, 2009
Last updated: March 28, 2014
Last verified: March 2014

July 23, 2009
March 28, 2014
July 2010
September 2016   (final data collection date for primary outcome measure)
  • Gene expression of Phase II enzymes [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Change in Phase II enzyme expression
  • Lipid oxidation [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Blood F2 Isoprostane levels
  • DNA oxidation [ Time Frame: Five weeks ] [ Designated as safety issue: No ]
    Prostate tissue 8OHdG levels
  • DHT levels [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Change in prostate tissue DHT levels
tissue F2isoprostanes [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00946309 on ClinicalTrials.gov Archive Site
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Effects of Sulforaphane on Normal Prostate Tissue
In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Prostate Cancer
  • 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
  • Experimental: High Sulforaphane Extract
    Intervention: Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
  • Placebo Comparator: Placebo
    Intervention: Drug: Microcrystalline Cellulose NF (placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
September 2016
September 2016   (final data collection date for primary outcome measure)

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 PSA 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
Male
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00946309
PHS 2333.00, 6969
Yes
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
  • VA Puget Sound Health Care System
  • Seattle Institute for Biomedical and Clinical Research
  • Johns Hopkins University
  • University of Washington
  • Cedars-Sinai Medical Center
Principal Investigator: Daniel W Lin, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
March 2014

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