Status:
COMPLETED
Chemoprevention of Prostate Cancer, HDAC Inhibition and DNA Methylation
Lead Sponsor:
Portland VA Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Oregon State University
Conditions:
Prostate Cancer Prevention
Eligibility:
MALE
21+ years
Phase:
NA
Brief 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 ...
Detailed Description
Prostate cancer is the most frequently diagnosed non-cutaneous cancer and is the second leading cause of cancer death in American men. The precise etiologic factors that initiate and enhance the progr...
Eligibility Criteria
Inclusion
- Men scheduled for a prostate biopsy
- Age 21 years or older
- Signed informed subject consent
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01265953
Start Date
July 1 2011
End Date
December 1 2015
Last Update
May 1 2019
Active Locations (2)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
2
Portland VA Medical Center
Portland, Oregon, United States, 97239