Status:
COMPLETED
Effects of Sulforaphane on Normal Prostate Tissue
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Conditions:
Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
PHASE1
PHASE2
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-sulforap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00946309
Start Date
July 1 2010
End Date
May 1 2015
Last Update
November 15 2016
Active Locations (1)
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1
VA Puget Sound
Seattle, Washington, United States, 98108