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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014