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

NCT00375765 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-01-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Dutasteride

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials, MD, PhD · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375765 on ClinicalTrials.gov