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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00375765 |
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 |
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Benign Prostatic Hyperplasia Prostate Cancer |
Drug: Dutasteride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 40 |
Study Start Date: | April 2005 |
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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Biopsy proven, localised (cT1 or cT2) prostate cancer scheduled for radical operation
Exclusion criteria:
Netherlands | |
GSK Investigational Site | |
NIJMEGEN, Netherlands, 6532 SZ | |
GSK Investigational Site | |
NIJMEGEN, Netherlands, 6525 GA |
Study Director: | GSK Clinical Trials, MD, PhD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 104274 |
Study First Received: | September 12, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00375765 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Dutasteride BPH Prostate cancer Gene expression PSA |
Dutasteride Hyperplasia Prostatic Diseases Genital Neoplasms, Male Prostatic Hyperplasia |
Dihydrotestosterone Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Enzyme Inhibitors Genital Diseases, Male Pharmacologic Actions |
Dutasteride Hyperplasia Neoplasms Pathologic Processes Neoplasms by Site Prostatic Hyperplasia Prostatic Neoplasms |