A Phase 4 interventional study of Dutasteride in Benign Prostatic Hyperplasia and Prostate Cancer, sponsored by GlaxoSmithKline. Completed at 2 sites in Netherlands. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-01-19.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 40 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Biopsy proven, localised (cT1 or cT2) prostate cancer scheduled for radical operation
Exclusion criteria:
Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months
Relative change in PCA3 (a prostate cancer-specific gene) expression per cell at 3 months Relative change in prostate volume at 3 months
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