Effects of a Genistein Concentrated Polysaccharide (GCP)... | NCT00584532

Studies
Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.

NCT00584532

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

Nov 24, 2023Actual

Enrollment

66Actual

Phase

Phase 2Phase 3

Conditions

Prostate Cancer

Interventions

Placebo
GCP - Genistein Combined Polysaccharide

Countries

Not provided

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

Dec 2007

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

Nov 2003

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2007Actual

First Submitted Date

Dec 22, 2007

First Submission Date that Met QC Criteria

Dec 22, 2007

First Posted Date

Jan 2, 2008Estimated

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

Nov 22, 2023

Last Update Posted Date

Nov 24, 2023Actual

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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Placebo Comparator	A=Placebo ARM of Study	Drug: Placebo
B	Active Comparator	B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.	Drug: GCP - Genistein Combined Polysaccharide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	10 Placebo Capsules taken orally every day.	A	Placebo capsules (contain cellulose only)

Measure	Description	Time Frame
Decrease in PSA levels in men on GCP		6 Months

Measure	Description	Time Frame
Increased PSA Doubling Time (PSADT)in men on GCP.		6 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be male and have a pathological diagnosis of prostate cancer
Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
No treatment (surgery, radiation, or hormones) prior to study entry.
PSA between 2.0 and 10.0 ng/ml.
If PSA is >10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.
No known allergy to soy or soy products.
The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).
Participant has not been on any previous GCP clinical trial.
Normal Chemistry values prior to study entry.

Exclusion Criteria:

No pathological documentation of prostate cancer.
Prior treatment for prostate cancer.
PSA >10.0 ng/ml but not on Active Surveillance for 12 months.
Allergy to soy or soy products.
Abnormal chemistry values.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert Hackman, MD	University of California, Davis - Dept. of Nutrition	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided