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

This study has been completed.
Sponsor:
Collaborator:
American Institute of Cancer Prevention
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00579332
First received: December 18, 2007
Last updated: December 21, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Biochemical Failure
 Dietary Supplement: brassica intervention
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • change in blood PSA levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • monitor for health events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2005
Study Completion Date: December 2006
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with PSA recurrence following prostatectomy

Exclusion Criteria:

  • Not using exogenous hormones
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Jay Fowke, Vanderbilt_University
ClinicalTrials.gov Identifier: NCT00579332     History of Changes
Other Study ID Numbers: 041001
Study First Received: December 18, 2007
Last Updated: December 21, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
PSA
biochemical failure

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

ClinicalTrials.gov processed this record on May 16, 2013