- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00579332
Effects of Brassica or Indole-3-carbinol on Prostatectomy Patients With PSA Recurrence
April 26, 2016 updated by: Jay Fowke, Vanderbilt University
Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc
Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 23233
- Vanderbilt_University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men with PSA recurrence following prostatectomy
Exclusion Criteria:
- Not using exogenous hormones
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
one a day placebo
|
diet and phyto-chemical intervention
|
Experimental: 2
Brassica intake
|
diet and phyto-chemical intervention
|
Experimental: 3
indole-3-carbinol supplement
|
diet and phyto-chemical intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in blood PSA levels
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
monitor for health events
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jay H Fowke, PhD, Vanderbilt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
December 18, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 24, 2007
Study Record Updates
Last Update Posted (Estimate)
April 27, 2016
Last Update Submitted That Met QC Criteria
April 26, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 041001 (Rutgers IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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