Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

September 24, 2016 updated by: Daniel Lin, Fred Hutchinson Cancer Center

In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Microcrystalline Cellulose NF (placebo)
250 mg every other day for 6 weeks
Experimental: High Sulforaphane Extract
Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
100 umol sulforaphane, every other day for 5 weeks
Other Names:
  • Broccoli Sprout Extract

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Johns Hopkins University
University of Washington
Cedars-Sinai Medical Center
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research

Investigators

  • Principal Investigator: Daniel W Lin, MD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

September 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHS 2333.00
  • 6969 (Other Identifier: FHCRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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