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Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

This study has been completed.
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Johns Hopkins University
University of Washington
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Daniel Lin, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00946309
First received: July 23, 2009
Last updated: September 24, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
Drug: Microcrystalline Cellulose NF (placebo)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Gene Expression of Phase II Enzymes [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Change in Phase II enzyme expression

  • Lipid Oxidation [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Blood F2 Isoprostane levels

  • DNA Oxidation [ Time Frame: Five weeks ] [ Designated as safety issue: No ]
    Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels

  • DHT Levels [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Change in serum dihydrotestosterone (DHT) levels

  • Testosterone Levels [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Change in testosterone (T) levels

  • 3-alpha-diol Gluconate Levels [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
    Change in serum 3-alpha-diol gluconate(3α-DG) levels


Enrollment: 45
Study Start Date: July 2010
Study Completion Date: May 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Sulforaphane Extract Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
100 umol sulforaphane, every other day for 5 weeks
Other Name: Broccoli Sprout Extract
Placebo Comparator: Placebo Drug: Microcrystalline Cellulose NF (placebo)
250 mg every other day for 6 weeks

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946309

Locations
United States, Washington
VA Puget Sound
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Johns Hopkins University
University of Washington
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Daniel W Lin, MD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Daniel Lin, Principal Investigator, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00946309     History of Changes
Other Study ID Numbers: PHS 2333.00  6969 
Study First Received: July 23, 2009
Results First Received: August 20, 2015
Last Updated: September 24, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 06, 2016