Clinical trial · Interventional
Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation
NCT01265953CI-TRIAL-00038400PBroCcompletedN/AResults 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 objective of the study is to identify mechanisms by which compounds found in cruciferous vegetables alter gene expression via epigenetic modifications (changes in gene expression) and may prevent prostate cancer development. The investigators have found that sulforaphane (SFN), an isothiocyanate found in cruciferous vegetables, inhibits histone deacetylase (HDAC) activity in human colorectal and 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 Prevention | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gelatin capsule containing microcrystalline cellulose. | Dietary Supplement | — | UNRESOLVED |
| SFN-rich broccoli sprout extract capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SFN-rich broccoli sprout extract capsules
- description
- Four weeks SFN-rich broccoli sprout extract (BSE) capsules: 200µmol of sulforaphane (SFN) daily, 2 capsules (1 capsule B.I.D.) daily
- interventionNames
- Drug: SFN-rich broccoli sprout extract capsules
- type
- PLACEBO_COMPARATOR
- label
- Placebo capsules
- description
- Four weeks placebo capsules: 2 capsules (1 capsule B.I.D.) daily
- interventionNames
- Dietary Supplement: Gelatin capsule containing microcrystalline cellulose.
Primary outcomes (4)
- measure
- Change of Total Urine SFN (Sulforaphane) Metabolites
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Men scheduled for a prostate biopsy * Age 21 years or older * Signed informed subject consent Exclusion Criteria: * Definitive diagnosis with prostate cancer * Significant active medical illness which in the opinion of the investigator or clinician would preclude protocol treatment * Diagnosis of liver disease as noted on the patient problem list or baseline total bilirubin greater than institutional upper limit of normal * Subject reported allergy or sensitivity to cruciferous vegetables * Use of oral antibiotics, with the exception of doxycycline, within three months prior to randomization * Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial. * Current oral steroid therapy * Current therapy with valproate or other pharmacological drugs associated with HDAC inhibition * Diagnosed dementia as noted on the patient problem list or other significant mental illness that may impact the subjects' ability to follow instructions or comply with the study protocol * Patient may not be a part of another flagged study * Patients already taking SFN dietary supplements
References
Publications (1)
- DERIVEDZhang Z, Garzotto M, Davis EW 2nd, Mori M, Stoller WA, Farris PE, Wong CP, Beaver LM, Thomas GV, Williams DE, Dashwood RH, Hendrix DA, Ho E, Shannon J. Sulforaphane Bioavailability and Chemopreventive Activity in Men Presenting for Biopsy of the Prostate Gland: A Randomized Controlled Trial. Nutr Cancer. 2020;72(1):74-87. doi: 10.1080/01635581.2019.1619783. Epub 2019 Jun 1. PMID 31155953