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In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

Phase 1/Phase 2
40 Years
75 Years
Open (Enrolling by invite only)
Prostate Cancer

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Trial Information

In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate

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

- Allergy to cruciferous vegetables or any of the specific fillers used in the placebo

- Usual consumption of > 5 servings per week of Brassica vegetables

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Gene expression of Phase II enzymes

Outcome Description:

Change in Phase II enzyme expression

Outcome Time Frame:

Baseline and 5 weeks

Safety Issue:


Principal Investigator

Daniel W Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Food and Drug Administration

Study ID:

PHS 2333.00



Start Date:

July 2010

Completion Date:

September 2016

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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