Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2010-07-31
2015-05-31
Brief Summary
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The investigators hypothesize that consumption of high-sulforaphane broccoli sprout extract every other day will inhibit growth of prostate cancer cells.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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High Sulforaphane Extract
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 6 weeks
Interventions
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High Sulforaphane Extract (Broccoli Sprout Extract)
100 umol sulforaphane, every other day for 5 weeks
Microcrystalline Cellulose NF (placebo)
250 mg every other day for 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
MALE
No
Sponsors
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VA Puget Sound Health Care System
FED
Seattle Institute for Biomedical and Clinical Research
OTHER
Johns Hopkins University
OTHER
University of Washington
OTHER
Cedars-Sinai Medical Center
OTHER
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Daniel Lin
Principal Investigator
Principal Investigators
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Daniel W Lin, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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VA Puget Sound
Seattle, Washington, United States
Countries
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Other Identifiers
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6969
Identifier Type: OTHER
Identifier Source: secondary_id
PHS 2333.00
Identifier Type: -
Identifier Source: org_study_id