Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia; Prostate Cancer
Intervention: Dutasteride (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical trials, MD, PhD, Study Chair, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: 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: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months
Secondary outcome: Relative change in PCA3 (a prostate cancer-specific gene) expression per cell at 3 months
Relative change in prostate volume at 3 months
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
GSK Clinical Trials Call Center, Nijmegen 6525GA, Netherlands
Additional Information
Starting date: March 2005
Last updated: November 8, 2007
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