N/A
Completed N=98
Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation
Prostate Cancer Prevention
Source: ClinicalTrials.gov NCT01265953 ↗
Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Change of Total Urine SFN (Sulforaphane) Metabolites — 4.75; -0.02 micromolar (µM) concentrations of urina
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Total Urine SFN (Sulforaphane) Metabolites |
4.75; -0.02 | — |
| PRIMARY Change of Total Plasma SFN (Sulforaphane) Metabolites Level |
0.12; -0.0003 | — |
| PRIMARY Percentage of Ki67 Positive Cells up to 8 Weeks Post-randomization |
1.8; 1.9 | — |
| PRIMARY Expression of Histone Deacetylase 6 (HDAC6) |
187; 183 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01265953). 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. Informational only — not medical advice.