Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate | NCT00880672

Studies
Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

NCT00880672

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 12, 2013Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Benign Prostatic Hyperplasia

Interventions

dutasteride

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

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

Apr 2009

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 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Apr 2009Actual

First Submitted Date

Apr 13, 2009

First Submission Date that Met QC Criteria

Apr 13, 2009

First Posted Date

Apr 14, 2009Estimated

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

Jun 10, 2013

Last Update Posted Date

Jun 12, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ja Hyeon Ku,, Associate Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
The Korean Urological Association	OTHER
GlaxoSmithKline	INDUSTRY

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 determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).

Detailed Description

A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dutasteride	Active Comparator	oral, 5mg, once per day, 2 weeks	Drug: dutasteride
placebo	Placebo Comparator	oral, 5mg, once per day, 2 weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dutasteride	Drug	5mg, oral, daily, 2-4 weeks	dutasteride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HIF-1a and VEGF expression	effects of dutasteride on the expression of angiogenesis markers in rat and human prostates	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent
50 years old or older
International Prostate Symptom Score (IPSS) >8
Maximum flow rate (Qmax) <15 ml/s
transurethral resection of the prostate (TURP)

Exclusion Criteria:

urethral catheter
urinary tract infection (UTI)
liver disease
renal disease
unexplained hematuria
prostate specific antigen (PSA) > 4ng/ml (included if prostate biopsy was negative)
interstitial cystitis
bladder cancer or prostate cancer
pelvic surgery or irradiation

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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
Jae-Seung paick, MD, PhD	Dept. of Urology, Seoul National University Hospital	Principal Investigator

Locations

Not provided

Type	Date	Date Unknown
Release	Dec 7, 2013
Reset	Jan 23, 2014
Release	Nov 18, 2014
Reset	Nov 25, 2014

Submission Tracking

Estimated Results First Submitted Date

Dec 7, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 7, 2013			Jan 23, 2014
Nov 18, 2014

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068538	Dutasteride

Ancestor Terms

ID	Term
D001378	Azasteroids
D013260	Steroids, Heterocyclic
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided