Benign Prostatic HyperplasiaPhase 4NCT00880672
Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate
A Phase 4 study testing dutasteride in people with Benign Prostatic Hyperplasia, run by Seoul National University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- urethral catheter
- urinary tract infection (UTI)
- liver disease
- renal disease
- unexplained hematuria
- prostate specific antigen (PSA) > 4ng/ml (included if prostate biopsy was negative)
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- interstitial cystitis
- bladder cancer or prostate cancer
- pelvic surgery or irradiation
About this study
Official title: Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride
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).
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- dutasteride
- Keywords
- prostate, dutasteride, vascular endothelial growth factor, hypoxia inducible factor
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasterideDrug
5mg, oral, daily, 2-4 weeks
| Study group | Role | What they receive |
|---|---|---|
| dutasteride | Active comparator | oral, 5mg, once per day, 2 weeks Receives: Drug: dutasteride |
| placebo | Placebo comparator | oral, 5mg, once per day, 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIF-1a and VEGF expression
effects of dutasteride on the expression of angiogenesis markers in rat and human prostates
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Urological Association, GlaxoSmithKline
- Responsible party
- Principal investigator, Ja Hyeon Ku,, Seoul National University Hospital
- Investigators
- Jae-Seung paick, MD, PhD, Principal investigator, Dept. of Urology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880672
- Sponsor's protocol ID
- JHKu1
- Status last verified
- Apr 2009
- First submitted
- 13 Apr 2009
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride
- ClinicalTrials.gov ID
- NCT00880672
- Acronym / sponsor ID
- JHKu1
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- prostate, dutasteride, vascular endothelial growth factor, hypoxia inducible factor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- The Korean Urological Association, GlaxoSmithKline
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dutasteride | Active comparator | Drug: dutasterideoral, 5mg, once per day, 2 weeks |
| placebo | Placebo comparator | –oral, 5mg, once per day, 2 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- urethral catheter
- urinary tract infection (UTI)
- liver disease
- renal disease
- unexplained hematuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dutasteride5mg, oral, daily, 2-4 weeks | Drug | dutasteride |
Primary outcome
HIF-1a and VEGF expression
Time frame: 2 weeks
effects of dutasteride on the expression of angiogenesis markers in rat and human prostates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Seung paick, MD, PhD principal investigator
Dept. of Urology, Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dutasteride in people with Benign Prostatic Hyperplasia, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIF-1a and VEGF expression (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.