Effects of Sulforaphane on Normal Prostate Tissue (PHASE)

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: High Sulforaphane Extract (Broccoli Sprout Extract)

Drug: Microcrystalline Cellulose NF (placebo)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00946309

6969 (Other Identifier)

PHS 2333.00

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No 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