Effects of Sulforaphane on Normal Prostate Tissue

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00946309
• Date of registration: 23/07/2009
• Primary sponsor: Fred Hutchinson Cancer Research Center
• Public title: Effects of Sulforaphane on Normal Prostate Tissue PHASE
• Scientific title: In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
• Date of first enrolment: July 2010
• Target sample size: 100
• Recruitment status: Enrolling by invitation
• URL: http://clinicaltrials.gov/show/NCT00946309
• 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

Countries of recruitment

United States

Contacts

• Name: Daniel W Lin, MD
• Affiliation: Fred Hutchinson Cancer Research Center

Key inclusion & exclusion 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 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



Age minimum: 40 Years
Age maximum: 75 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: High Sulforaphane Extract (Broccoli Sprout Extract)

Drug: Microcrystalline Cellulose NF (placebo)

Primary Outcome(s)

DHT levels [Time Frame: Baseline and 5 weeks]

DNA oxidation [Time Frame: Five weeks]

Gene expression of Phase II enzymes [Time Frame: Baseline and 5 weeks]

Lipid oxidation [Time Frame: Baseline and 5 weeks]

Secondary ID(s)

6969

PHS 2333.00

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cedars-Sinai Medical Center

Johns Hopkins University

Seattle Institute for Biomedical and Clinical Research

University of Washington

VA Puget Sound Health Care System