Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00880672

Enrollment

Registered

2009-04-14

Start date

2008-01-31

Completion date

2009-04-30

Last updated

2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Keywords

prostate, dutasteride, vascular endothelial growth factor, hypoxia inducible factor

Brief summary

The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).

Detailed description

A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.

Interventions

DRUGdutasteride

5mg, oral, daily, 2-4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* informed consent * 50 years old or older * International Prostate Symptom Score (IPSS) \>8 * Maximum flow rate (Qmax) \<15 ml/s * transurethral resection of the prostate (TURP)

Exclusion criteria

* urethral catheter * urinary tract infection (UTI) * liver disease * renal disease * unexplained hematuria * prostate specific antigen (PSA) \> 4ng/ml (included if prostate biopsy was negative) * interstitial cystitis * bladder cancer or prostate cancer * pelvic surgery or irradiation

Design outcomes

Primary

Measure	Time frame	Description
HIF-1a and VEGF expression	2 weeks	effects of dutasteride on the expression of angiogenesis markers in rat and human prostates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026