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Effects of Brassica or Indole-3-carbinol on Prostatectomy Patients With PSA Recurrence

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ClinicalTrials.gov Identifier: NCT00579332
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : April 27, 2016
Sponsor:
Collaborator:
American Institute of Cancer Prevention
Information provided by (Responsible Party):
Jay Fowke, Vanderbilt University

Brief Summary:
Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.

Condition or disease Intervention/treatment Phase
Biochemical Failure Dietary Supplement: brassica intervention Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc
Study Start Date : January 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. change in blood PSA levels [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. monitor for health events [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with PSA recurrence following prostatectomy

Exclusion Criteria:

  • Not using exogenous hormones

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579332


Locations
United States, Tennessee
Vanderbilt_University
Nashville, Tennessee, United States, 23233
Sponsors and Collaborators
Vanderbilt University
American Institute of Cancer Prevention
Investigators
Principal Investigator: Jay H Fowke, PhD Vanderbilt University

Responsible Party: Jay Fowke, Associate Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00579332     History of Changes
Other Study ID Numbers: 041001
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Jay Fowke, Vanderbilt University:
PSA
biochemical failure

Additional relevant MeSH terms:
Indole-3-carbinol
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents