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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00375765
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Duration (Months): 27
• Patients Per Site: 20
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia; Prostate Cancer	Drug: Dutasteride	Phase 4

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Parallel-group Study, to Assess the Pharmocodynamic Effect on Dihydrotestosterone Regulated Gene Expression, Longitudinally and in a Dose Dependent Manner, of 0.5mg and 3.5mg Dutasteride Administered Orally Once Daily, for One Year in Men With Symptomatic Benign Prostatic Hyperplasia and During a Two Month Period Between Baseline and Radical Prostatectomy in Men With Biopsy-proven, Clinically Localized Prostate Cancer
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months []

Secondary Outcome Measures

1. Relative change in PCA3 (a prostate cancer-specific gene) expression per cell at 3 months Relative change in prostate volume at 3 months []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Nijmegen		Netherlands	6525 GA
2	GSK Investigational Site	Nijmegen		Netherlands	6532 SZ

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, MD, PhD, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00375765
• Other Study ID Numbers: 104274
• First Posted: Sep 13, 2006
• Last Update Posted: Jan 19, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by , ,: Dutasteride; BPH; Prostate cancer; Gene expression; PSA
• Additional relevant MeSH terms: Prostatic Neoplasms; Prostatic Hyperplasia; Hyperplasia; Dutasteride

Study Results

No Results Posted as of Jan 19, 2017