In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- DHT Levels
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
High Sulforaphane Extract
Intervention: High Sulforaphane Extract (Broccoli Sprout Extract) (Drug)
Placebo
Intervention: Microcrystalline Cellulose NF (placebo) (Drug)
Outcomes
Primary Outcomes
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
Gene Expression of Phase II Enzymes
Time Frame: Baseline and 5 weeks
Change in Phase II enzyme expression
DNA Oxidation
Time Frame: Five weeks
Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
Lipid Oxidation
Time Frame: Baseline and 5 weeks
Blood F2 Isoprostane levels
3-alpha-diol Gluconate Levels
Time Frame: Baseline and 5 weeks
Change in serum 3-alpha-diol gluconate(3α-DG) levels
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Lin
Principal Investigator
Fred Hutchinson Cancer Center