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OpenTrials
Completed

NCT Number: NCT00946309

Effects of Sulforaphane on Normal Prostate Tissue

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

VA Puget Sound

Seattle, Washington, 98108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Sulforaphane Extract (Broccoli Sprout Extract)

Drug

100 umol sulforaphane, every other day for 5 weeks

Other names: Broccoli Sprout Extract

Microcrystalline Cellulose NF (placebo)

Drug

250 mg every other day for 6 weeks

Primary outcomes

  1. Gene Expression of Phase II Enzymes

    Time frame: Baseline and 5 weeks

    Change in Phase II enzyme expression

  2. Lipid Oxidation

    Time frame: Baseline and 5 weeks

    Blood F2 Isoprostane levels

  3. DNA Oxidation

    Time frame: Five weeks

    Prostate tissue 8-hydroxy-2'-deoxyguanosine (8OHdG) levels

  4. DHT Levels

    Time frame: Baseline and 5 weeks

    Change in serum dihydrotestosterone (DHT) levels

  5. Testosterone Levels

    Time frame: Baseline and 5 weeks

    Change in testosterone (T) levels

  6. 3-alpha-diol Gluconate Levels

    Time frame: Baseline and 5 weeks

    Change in serum 3-alpha-diol gluconate(3α-DG) levels

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

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

Registry information

Official study title

In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

Acronym: PHASE

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jul 27, 2009
Registry last updated
Nov 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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