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Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer

NCT ID: NCT00375765

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-07-31

Brief Summary

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Dutasteride is used in the treatment of benign prostate enlargement (BPH).It inhibits conversion of testosterone (T) into the more potent dihydrotestosterone (DHT) to stop prostate (and possibly prostate cancer) growth. DHT regulates the expression of certain genes in the prostate. The pharmacodynamics of DHT reduction in the prostate were never investigated until now, as every measurement would require prostate tissue retrieval, which is medically and ethically unacceptable. A recently developed test is able to quantitatively measure gene expression in prostate-borne cells, in urine sediments after prostate massage. By measuring this gene expression in patients using dutasteride, it has become possible to assess the pharmacodynamics of gene expression reduction, which is representative for the pharmacodynamics of DHT reduction. Repeated prostate tissue sampling has therefore become unnecessary. This newly gained knowledge will lead to a better understanding of the action of dutasteride and will possibly help improve treatment of symptomatic BPH (Benign Prostatic Hyperplasia) and PrCa (Prostate Cancer)in the future.

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Detailed Description

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A randomized, open-label, parallel-group pilot study, to assess the pharmacodynamic effect on dihydrotestosterone regulated gene expression, longitudinally and in a dose dependent manner, of 0.5mg or 3.5mg dutasteride administered orally once daily, for three months in men with symptomatic benign prostatic hyperplasia or during the period between baseline and radical prostatectomy in men with biopsy-proven, clinically localized prostate cancer.

Conditions

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Benign Prostatic Hyperplasia Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dutasteride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Symptomatic BPH, or:

Biopsy proven, localised (cT1 or cT2) prostate cancer scheduled for radical operation

* Able to swallow oral medication

Exclusion Criteria

* Inability to void spontaneously (eg. dependence on catheter etc.)
* History of (prior) prostate cancer Previous prostatic surgery
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD, PhD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Nijmegen, , Netherlands

Site Status

GSK Investigational Site

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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104274

Identifier Type: -

Identifier Source: org_study_id

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