Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation
Completed · Not applicable · Has a placebo group
Conditions studied: Prostate Cancer Prevention
In brief
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.
Key facts
- Study ID
- NCT01265953
- Run by
- Portland VA Medical Center
- People needed
- 98
- Starts
- 2011-07-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2019-05-01
Who can join
Age: 21 and older. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Men scheduled for a prostate biopsy
- Age 21 years or older
- Signed informed subject consent
You may not qualify if…
- 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
Where it is running
- OHSU Knight Cancer Institute — Portland, Oregon, United States
- Portland VA Medical Center — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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