Effects of Sulforaphane on Normal Prostate Tissue

Study 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.

Official Title
-----------------
In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
* Drug: Microcrystalline Cellulose NF (placebo)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Sulforaphane Extract<br> | Drug: High Sulforaphane Extract (Broccoli Sprout Extract)<br>* 100 umol sulforaphane, every other day for 5 weeks<br>* Other names: Broccoli Sprout Extract;|
| Placebo Comparator: Placebo<br> | Drug: Microcrystalline Cellulose NF (placebo)<br>* 250 mg every other day for 6 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene Expression of Phase II Enzymes | Change in Phase II enzyme expression | Baseline and 5 weeks | 
| Lipid Oxidation | Blood F2 Isoprostane levels | Baseline and 5 weeks | 
| DNA Oxidation | Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels | Five weeks | 
| DHT Levels | Change in serum dihydrotestosterone (DHT) levels | Baseline and 5 weeks | 
| Testosterone Levels | Change in testosterone (T) levels | Baseline and 5 weeks | 
| 3-alpha-diol Gluconate Levels | Change in serum 3-alpha-diol gluconate(3α-DG) levels | Baseline and 5 weeks |