Ignite Creation Date:
2024-05-05 @ 11:10 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01265953
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2010-12-16
Brief Title:
Chemoprevention of Prostate Cancer HDAC Inhibition and DNA Methylation
Sponsor:
Portland VA Medical Center
Organization:
Portland VA Medical Center
Study Overview
Official Title:
Chemoprevention of Prostate Cancer HDAC Inhibition and DNA Methylation
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PBroC
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 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
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
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 progression of prostate cancer remain unknown but epigenetic alterations and dietlifestyle factors have come forth as significant contributing factors Epidemiologic studies suggest that cruciferous vegetable intake decreases the risk for prostate cancer The long-term goal of this proposal is to identify mechanisms by which dietary compounds such as those found in cruciferous vegetables decrease prostate cancer risk The objective of the study is to identify mechanisms by which compounds found in cruciferous vegetables alter gene expression via epigenetic modifications and may prevent prostate cancer development
The investigators have found that SFN an isothiocyanate found in cruciferous vegetables inhibits HDAC activity in human colorectal and prostate cancer cells
Targeting the epigenome including the use of HDAC and DNA methyltransferase DNMT inhibitors is an evolving strategy for cancer chemoprevention and both have shown promise in cancer clinical trials
This Randomized Double Blind Clinical Trial will address the following objectives
1 Identify distribution of SFN and its metabolites and HDAC inhibition following supplementation with an SFN-rich broccoli sprout extract in subjects at risk for prostate cancer Primary Endpoints
2 Investigate the effects of supplementation with an SFN-rich broccoli sprout extract on DNA methylation status and proliferation markers in a pre-biopsy setting secondary analysis
The effects of short-term supplementation with an SFN-rich broccoli sprout extract on benign epithelial tissue will be studied in men characterized as being at risk for prostate cancer in a randomized placebo-controlled trial Men scheduled for prostate biopsy will be recruited into the trial
Following successful completion of the consent two 10 mL blood specimens for study analyses a 4 mL specimen for total bilirubin assessment will be drawn and the subject will provide a urine sample The study coordinator will explain the Diet History questionnaires DHQ and administer the risk factor and adverse event AE questionnaires in order to obtain data on potential confounding dietary variables and gain subjects baseline symptoms
The study coordinator will provide the subject with a month supply of either an SFN-rich broccoli sprout extract BSE capsule which consist of 200µmol of sulforaphane SFN or matching placebo as dispensed by the Research Pharmacy The matching placebo for the BSE consists of a gelatin capsule containing microcrystalline cellulose
Around every 2 weeks study coordinator will call to complete AE reporting and any changes in medications or supplements and complete brief cruciferous vegetable intake checklist Subjects will return any unused study drug to the study coordinator at the time of biopsy or at the 4 week visit if subjects prostate biopsy is delayed
The investigators have found that SFN an isothiocyanate found in cruciferous vegetables inhibits HDAC activity in human colorectal and prostate cancer cells
Targeting the epigenome including the use of HDAC and DNA methyltransferase DNMT inhibitors is an evolving strategy for cancer chemoprevention and both have shown promise in cancer clinical trials
This Randomized Double Blind Clinical Trial will address the following objectives
1 Identify distribution of SFN and its metabolites and HDAC inhibition following supplementation with an SFN-rich broccoli sprout extract in subjects at risk for prostate cancer Primary Endpoints
2 Investigate the effects of supplementation with an SFN-rich broccoli sprout extract on DNA methylation status and proliferation markers in a pre-biopsy setting secondary analysis
The effects of short-term supplementation with an SFN-rich broccoli sprout extract on benign epithelial tissue will be studied in men characterized as being at risk for prostate cancer in a randomized placebo-controlled trial Men scheduled for prostate biopsy will be recruited into the trial
Following successful completion of the consent two 10 mL blood specimens for study analyses a 4 mL specimen for total bilirubin assessment will be drawn and the subject will provide a urine sample The study coordinator will explain the Diet History questionnaires DHQ and administer the risk factor and adverse event AE questionnaires in order to obtain data on potential confounding dietary variables and gain subjects baseline symptoms
The study coordinator will provide the subject with a month supply of either an SFN-rich broccoli sprout extract BSE capsule which consist of 200µmol of sulforaphane SFN or matching placebo as dispensed by the Research Pharmacy The matching placebo for the BSE consists of a gelatin capsule containing microcrystalline cellulose
Around every 2 weeks study coordinator will call to complete AE reporting and any changes in medications or supplements and complete brief cruciferous vegetable intake checklist Subjects will return any unused study drug to the study coordinator at the time of biopsy or at the 4 week visit if subjects prostate biopsy is delayed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2096 | OTHER | None | None |
| 6232 | OTHER | None | None |
| 2P01CA090890-06A2 | NIH | OHSU IRB | httpsreporternihgovquickSearch2P01CA090890-06A2 |