Synthetic Genistein (BONISTEIN™) in Patients Who Are Unde... | NCT00546039

Studies
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer

NCT00546039

Sponsor

University Hospital, Aker

Status

Unknown status

Last Update Posted

Sep 30, 2008Estimated

Enrollment

47Actual

Phase

Phase 2

Conditions

Prostatic Neoplasms

Interventions

Genistein
Placebo

Countries

Norway

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Aug 2008Actual

Completion Date

Jan 2009Estimated

First Submitted Date

Oct 17, 2007

First Submission Date that Met QC Criteria

Oct 17, 2007

First Posted Date

Oct 18, 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

Sep 29, 2008

Last Update Posted Date

Sep 30, 2008Estimated

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

Description Module

Brief Summary

The purpose of this study is to evaluate safety and mechanisms of possible chemopreventive effects of synthetic genistein (BONISTEIN™) in patients with localized prostate cancer undergoing laparoscopic radical prostatectomy.

Detailed Description

In Norway prostate cancer is the most frequently diagnosed cancer in the male and represents the second most common cause of cancer death among men. Epidemiological studies have shown an association between decreased prostate cancer risk and increased soy consumption. Genistein is the dominating plasma and tissue isoflavone in soybean products, and it has been attributed several anti-cancer effects. BONISTEIN™ is a novel product, consisting of >99,5 % synthetic Genistein aglycone. Chemoprevention is the ability of certain molecules to inhibit (partially or totally) induction or progression of the disease. Our study population consists of men diagnosed with localized prostate cancer who have agreed to undergo radical prostatectomy. This provides adequate amount of benign, premalignant and malignant tissue for studying the effects of potential chemopreventive agents on biomarkers of cell growth and differentiation in the prostatic tissues with immunohistochemistry. Prostatic tissue cells will also be selected with Lacer Capture Microdissection (LCM) before analysis with semi-quantitative RT-PCR.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Genistein
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genistein	Drug	Capsule, 30 mg, oral daily for 3 to 6 weeks	1	BONISTEIN™

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modulation of biomarkers: PSA, Testosterone, STAMP1, STAMP2, NKX3A and KLK4, p21, p27, p53, bcl-2, bax, Ki67, CgA and NSE in blood and/or prostate tissue.		3 to 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Modulation of prostate cancer grade, volume and Gleason score. Safety parameters (blood, electrolytes, liver, pancreas, lipids, thyroid and sexual hormones). Plasma and tissue concentrations of BONISTEIN™.		3 to 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological proven prostate cancer clinical stage T1c or T2.
Are to be treated by radical prostatectomy 3 to 6 weeks after consent.
Have signed the informed consent form.

Exclusion Criteria:

Have been on previous or concurrent hormonal therapy or chemotherapy.
History of previous or other hormone dependent malignancies.
Concomitant thyroid disease or are currently taking thyroid hormone replacement medication.
On current high dose soy, micronutrient or herbal supplements.
On soy or vegetarian nutrition or have any other extreme dietary habits.
On oral anticoagulants.
History of liver or pancreas diseases.
History of hypersensitivity to Genistein or soy containing products.
Have a malabsorption condition which might interfere with absorption of the investigational product.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Steinar J Karlsen, MD, PhD	Aker University Hospital, Oslo Urological Universityclinic	Study Director
Bato Lazarevic, MD	Aker University Hospital, Oslo Urological Universityclinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aker University Hospital		Oslo		0514	Norway

Label	URL
Homepage Aker University Hospital	View source

Type	Date	Date Unknown
Release	Apr 4, 2011
Reset	Apr 28, 2011
Release	May 3, 2011
Reset	Jun 2, 2011
Release	Jul 3, 2011
Reset	Jul 29, 2011
Release	Aug 15, 2011
Reset	Sep 19, 2011

Submission Tracking

Estimated Results First Submitted Date

Apr 4, 2011

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 4, 2011			Apr 28, 2011
May 3, 2011

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019833	Genistein

Ancestor Terms

ID	Term
D007529	Isoflavones
D005419	Flavonoids
D002867	Chromones
D001578	Benzopyrans
D011714

Browse Leaves

Not provided

Browse Branches

Not provided