Clinical trial · Interventional
Effects of Sulforaphane on Normal Prostate Tissue
In Vivo Effects of Sulforaphane Supplementation on Normal Human Prostate
NCT00946309CI-TRIAL-00024784PHASEcompletedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Sulforaphane Extract (Broccoli Sprout Extract) | Drug | — | UNRESOLVED |
| Microcrystalline Cellulose NF (placebo) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High Sulforaphane Extract
- interventionNames
- Drug: High Sulforaphane Extract (Broccoli Sprout Extract)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Microcrystalline Cellulose NF (placebo)
Primary outcomes (6)
- measure
- Gene Expression of Phase II Enzymes
- timeFrame
- Baseline and 5 weeks
- description
- Change in Phase II enzyme expression
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.