Last updated: 11/03/2018 00:32:48
Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial 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 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Dutasteride
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Benign Prostatic Hyperplasia, Prostate Cancer
Product
dutasteride
Collaborators
Not applicable
Study date(s)
April 2005 to July 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
no
- Symptomatic BPH, or:
- Biopsy proven, localised (cT1 or cT2) prostate cancer scheduled for radical operation
- Inability to void spontaneously (eg. dependence on catheter etc.)
- History of (prior) prostate cancer
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-04-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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