Effects of Sulforaphane on Normal Prostate Tissue

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: High Sulforaphane Extract (Broccoli Sprout Extract); Drug: Microcrystalline Cellulose NF (placebo)

• Registration Number: NCT00946309
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Study Start: 2010-07
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Results First Submitted: 2015-08-20
• Status Verified: 2016-06
• Results First Submitted QC: 2016-09-24
• Last Update Submitted: 2016-09-24
• Results First Posted: 2016-11-15
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Sulforaphane Extract	High Sulforaphane Extract (Broccoli Sprout Extract)	-
Placebo	Microcrystalline Cellulose NF (placebo)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

VA Puget Sound; 🇺🇸 Seattle, Washington, United States