Benign Prostatic HyperplasiaNCT01351987
An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
An observational study of Benign Prostatic Hyperplasia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- How many people
- 855 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2010to Dec 2013
- Phase
- Observational
- 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
Study population: Benign Prostatic Hyperplasia male paitents
Who may be able to join
- Males, age ≧ 50 years
- Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
- IPSS score ≧ 8 points and prostate volume ≧ 30 mL
- Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening
- Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months.
- Dutasteride combination therapy will be allowed by investigator's prescription
- Ability to understand and willingly provide written informed consent
Who cannot join
- History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN)
- With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study
- Use of finasteride within 6 months of screening visit
- Use of dutasteride within 12 months of screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Dutasteride and Alpha-Blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.
Read the detailed description
This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startDec 2010
- Study completionDec 2013 (estimated)
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.
- 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
- Observational
- Observational model
- Case only
- Enrolment
- 855 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Liang-Ming Lee, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351987
- Sponsor's protocol ID
- 100006
- Status last verified
- May 2011
- First submitted
- 10 May 2011
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Dutasteride and Alpha-Blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
- ClinicalTrials.gov ID
- NCT01351987
- Acronym / sponsor ID
- 100006
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 855 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 May 2011 (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.
To analyze the change in International Prostate Symptom Score (IPSS) and serum prostate-specific antigen (PSA) level from baseline.
Detailed description
This is a non-interventional, observational and multicenter study. When subjects will be allowed the dutasteride and α-blocker orally once daily for two years by investigator's prescription. They will be invited to this observational study. All eligible subjects can be allowed the prior alpha blockers therapy. Details of acute urinary retention (AUR) and BPH-related prostatic surgery episodes will be recorded at every visit. Subjects will return to the clinic for assessment every 3 months until week 96. The efficacy and safety of combining the 5α-reductase inhibitor (5ARI), dutasteride, and the α-blocker will be assessed.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Benign Prostatic Hyperplasia male paitents
Key inclusion criteria (7 listed)
- Males, age ≧ 50 years
- Clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
- IPSS score ≧ 8 points and prostate volume ≧ 30 mL
- Total serum PSA ≧ 4.0 ng/mL and ≦ 20 ng/mL at screening
- Previous TRUS-guided biopsy have been done with benign findings and with prostate cancer (CaP) not detected within the past 6 months.
Key exclusion criteria (4 listed)
- History or evidence of prostate cancer and high grade prostatic intraepithelial neoplasia (HGPIN)
- With symptomatic urinary tract or prostate infection or urinary retention within 3 months prior to entry of study
- Use of finasteride within 6 months of screening visit
- Use of dutasteride within 12 months of screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
Related trials for Benign Prostatic Hyperplasia
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
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.
Liang-Ming Lee principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
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 11 May 2011.