Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia; Prostate Cancer
Intervention: Dutasteride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, PhD, Study Director, 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: See Detailed Description
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
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
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 Investigational Site, Nijmegen 6525 GA, Netherlands
GSK Investigational Site, Nijmegen 6532 SZ, Netherlands
Additional Information
Starting date: April 2005
Last updated: May 21, 2009
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