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

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

This study has been completed.

Sponsors and Collaborators:	Vanderbilt University Institute for Cancer Prevention
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00579332

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 II Phase III

ChemIDplus related topics:

Indole-3-carbinol Methanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc

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 ]

Arms	Assigned Interventions
1: Placebo Comparator one a day placebo	Dietary Supplement: brassica intervention diet and phyto-chemical intervention
2: Experimental Brassica intake	Dietary Supplement: brassica intervention diet and phyto-chemical intervention
3: Experimental indole-3-carbinol supplement	Dietary Supplement: brassica intervention diet and phyto-chemical intervention

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Institute for Cancer Prevention

Investigators


Principal Investigator:	Jay H Fowke, PhD	Vanderbilt University

More Information

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

Keywords provided by Vanderbilt University:

PSA

biochemical failure

Study placed in the following topic categories:

Recurrence

Indole-3-carbinol

Additional relevant MeSH terms:

Anticarcinogenic Agents

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008