Phase 2
N=45
Effects of Sulforaphane on Normal Prostate Tissue
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00946309 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Gene Expression of Phase II Enzymes — -0.36; 0.26; 0.15; -0.59 -fold change in expression
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- High Sulforaphane Extract (Broccoli Sprout Extract) (Drug); Microcrystalline Cellulose NF (placebo) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gene Expression of Phase II Enzymes |
-0.36; 0.26; 0.15; -0.59; -0.02; 0.42 | — |
| PRIMARY Lipid Oxidation |
— | — |
| PRIMARY DNA Oxidation |
— | — |
| PRIMARY DHT Levels |
2.09; 19.33 | — |
| PRIMARY Testosterone Levels |
-36.79; 5.75 | — |
| PRIMARY 3-alpha-diol Gluconate Levels |
-0.69; 0.39 | — |
Summary
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00946309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.