Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375765
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2006-09-12
Brief Title:
Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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 05mg and 35mg 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
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dutasteride is used in the treatment of benign prostate enlargement BPHIt 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 Cancerin the future
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 05mg or 35mg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None