See Detailed Description
50 Years
N/A
Male
Benign Prostatic Hyperplasia, Prostate Cancer
Trial Information
See 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months
Principal Investigator
GSK Clinical Trials, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
104274
NCT ID:
NCT00375765
Start Date:
April 2005
Completion Date:
Related Keywords:
- Benign Prostatic Hyperplasia
- Prostate Cancer
- Dutasteride
- BPH
- Prostate cancer
- Gene expression
- PSA
- Prostatic Hyperplasia
- Hyperplasia
- Prostatic Neoplasms
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