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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 Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: High Sulforaphane Extract (Broccoli Sprout Extract) Drug: Microcrystalline Cellulose NF (placebo) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
Study Start Date : July 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High Sulforaphane Extract Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
100 umol sulforaphane, every other day for 5 weeks
Other Name: Broccoli Sprout Extract
Placebo Comparator: Placebo Drug: Microcrystalline Cellulose NF (placebo)
250 mg every other day for 6 weeks


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

  2. Lipid Oxidation [ Time Frame: Baseline and 5 weeks ]
    Blood F2 Isoprostane levels

  3. DNA Oxidation [ Time Frame: Five weeks ]
    Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels

  4. DHT Levels [ Time Frame: Baseline and 5 weeks ]
    Change in serum dihydrotestosterone (DHT) levels

  5. Testosterone Levels [ Time Frame: Baseline and 5 weeks ]
    Change in testosterone (T) levels

  6. 3-alpha-diol Gluconate Levels [ Time Frame: Baseline and 5 weeks ]
    Change in serum 3-alpha-diol gluconate(3α-DG) levels


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946309


Locations
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United States, Washington
VA Puget Sound
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Fred Hutchinson Cancer Center
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Johns Hopkins University
University of Washington
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Daniel W Lin, MD Fred Hutchinson Cancer Center
More Information
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Responsible Party: Daniel Lin, Principal Investigator, Fred Hutchinson Cancer Center
ClinicalTrials.gov Identifier: NCT00946309    
Other Study ID Numbers: PHS 2333.00
6969 ( Other Identifier: FHCRC )
First Posted: July 27, 2009    Key Record Dates
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Sulforaphane
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents