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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00375765
First received: September 12, 2006
Last updated: May 21, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Prostate Cancer
Drug: Dutasteride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months

Secondary Outcome Measures:
  • Relative change in PCA3 (a prostate cancer-specific gene) expression per cell at 3 months Relative change in prostate volume at 3 months

Estimated Enrollment: 40
Study Start Date: April 2005
Intervention Details:
    Drug: Dutasteride
    Other Name: Dutasteride
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375765

Locations
Netherlands
GSK Investigational Site
Nijmegen, Netherlands, 6532 SZ
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00375765     History of Changes
Other Study ID Numbers: 104274
Study First Received: September 12, 2006
Last Updated: May 21, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Dutasteride
BPH
Prostate cancer
Gene expression
PSA

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 23, 2014