Effects of Sulforaphane on Normal Prostate Tissue

Prostate Cancer Clinical Trial

— PHASE  

Official title:

In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00946309
• Other study ID #: PHS 2333.00
• Secondary ID: 6969
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: July 23, 2009
• Last updated: March 28, 2014
• Start date: July 2010
• Est. completion date: September 2016

Study information

• Verified date: March 2014
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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 PSA 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	VA Puget Sound	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Cedars-Sinai Medical Center, Johns Hopkins University, Seattle Institute for Biomedical and Clinical Research, University of Washington, VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression of Phase II enzymes	Change in Phase II enzyme expression	Baseline and 5 weeks	No
Primary	Lipid oxidation	Blood F2 Isoprostane levels	Baseline and 5 weeks	No
Primary	DNA oxidation	Prostate tissue 8OHdG levels	Five weeks	No
Primary	DHT levels	Change in prostate tissue DHT levels	Baseline and 5 weeks	No