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Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High Sulforaphane Extract (Broccoli Sprout Extract)
Microcrystalline Cellulose NF (placebo)
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • VA Puget Sound

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High Sulforaphane Extract

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 23, 2009
Last Updated
September 24, 2016
Sponsor
Fred Hutchinson Cancer Center
Collaborators
VA Puget Sound Health Care System, Seattle Institute for Biomedical and Clinical Research, Johns Hopkins University, University of Washington, Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00946309
Brief Title
Effects of Sulforaphane on Normal Prostate Tissue
Acronym
PHASE
Official Title
In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
VA Puget Sound Health Care System, Seattle Institute for Biomedical and Clinical Research, Johns Hopkins University, University of Washington, Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Sulforaphane Extract
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
High Sulforaphane Extract (Broccoli Sprout Extract)
Other Intervention Name(s)
Broccoli Sprout Extract
Intervention Description
100 umol sulforaphane, every other day for 5 weeks
Intervention Type
Drug
Intervention Name(s)
Microcrystalline Cellulose NF (placebo)
Intervention Description
250 mg every other day for 6 weeks
Primary Outcome Measure Information:
Title
Gene Expression of Phase II Enzymes
Description
Change in Phase II enzyme expression
Time Frame
Baseline and 5 weeks
Title
Lipid Oxidation
Description
Blood F2 Isoprostane levels
Time Frame
Baseline and 5 weeks
Title
DNA Oxidation
Description
Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels
Time Frame
Five weeks
Title
DHT Levels
Description
Change in serum dihydrotestosterone (DHT) levels
Time Frame
Baseline and 5 weeks
Title
Testosterone Levels
Description
Change in testosterone (T) levels
Time Frame
Baseline and 5 weeks
Title
3-alpha-diol Gluconate Levels
Description
Change in serum 3-alpha-diol gluconate(3α-DG) levels
Time Frame
Baseline and 5 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel W Lin, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Effects of Sulforaphane on Normal Prostate Tissue

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