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

  • United States
    • 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
Dietary supplement: brassica intervention
diet and phyto-chemical intervention
Experimental: 2
Brassica intake
Dietary supplement: brassica intervention
diet and phyto-chemical intervention
Experimental: 3
indole-3-carbinol supplement
Dietary supplement: brassica intervention
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

Vanderbilt University

Collaborators

American Institute of Cancer Prevention

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.

Subscribe