Effects of Brassica or Indole-3-carbinol on Prostatectomy... | NCT00579332

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

NCT00579332

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Apr 27, 2016Estimated

Enrollment

16Actual

Phase

Phase 2Phase 3

Conditions

Biochemical Failure

Interventions

brassica intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Dec 18, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Dec 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Name	Class
American Institute of Cancer Prevention	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	one a day placebo	Dietary Supplement: brassica intervention
2	Experimental	Brassica intake	Dietary Supplement: brassica intervention
3	Experimental	indole-3-carbinol supplement	Dietary Supplement: brassica intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
brassica intervention	Dietary Supplement	diet and phyto-chemical intervention	1 2 3

Measure	Description	Time Frame
change in blood PSA levels		6 months

Measure	Description	Time Frame
monitor for health events		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men with PSA recurrence following prostatectomy

Exclusion Criteria:

Not using exogenous hormones

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jay H Fowke, PhD	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt_University		Nashville	Tennessee	23233	United States