Prostatic HyperplasiaNCT01332487

Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of… Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: Prostatic Hyperplasia
What is being tested?: 5ARI + AB
How many people: 4,068 participants
Where: No sites listed yet
Study dates: Aug 2010to Aug 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Male patients aged 50 years or older with a diagnostic claim for BPH; prescription claim for an AB and a 5ARI in the observation period

Who may be able to join

Male
aged 50 years or older
diagnostic claim for BPH
prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
continuously eligible for 6 months prior to and 12 months after index prescription date

Who cannot join

prostate or bladder cancer during the study period
any prostate-related surgical procedure within 5 months of the index prescription date
prescription claim for finasteride 1 mg for male pattern baldness during the study period
5ARI therapy prior to initiation of AB therapy

About this study

Conditions: Prostatic Hyperplasia
Being tested: 5ARI + AB
Keywords: 5-alpha-reductase inhibitor, prostate surgery, alpha-blocker, enlarged prostate, acute urinary retention, Benign prostatic hyperplasia
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5ARI + ABDrug
5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Study groups in NCT01332487
Study group	Role	What they receive
Early initiation of 5ARI therapy		Patients starting 5ARI therapy within 30 days of initiating AB therapy Receives: Drug: 5ARI + AB
Delayed initiation of 5ARI therapy		Patients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy Receives: Drug: 5ARI + AB

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced Progression of Disease
The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.
Measured: Up to 5 months

Secondary outcomes (1)

Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Aug 2010

First posted11 Apr 2011 (estimated)
Study startAug 2010
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 4,068 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332487
Sponsor's protocol ID: 114461
Status last verified: May 2017
First submitted: 7 Apr 2011
Last updated: 19 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT01332487
Acronym / sponsor ID: 114461
Conditions: Prostatic Hyperplasia
Keywords: 5-alpha-reductase inhibitor, prostate surgery, alpha-blocker, enlarged prostate, acute urinary retention, Benign prostatic hyperplasia
Study type: Observational
Recruitment status: Completed
Enrolment: 4,068 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 11 Apr 2011 (estimated)
Results: Posted 29 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Early initiation of 5ARI therapy	–	Drug: 5ARI + ABPatients starting 5ARI therapy within 30 days of initiating AB therapy
Delayed initiation of 5ARI therapy	–	Drug: 5ARI + ABPatients starting 5ARI therapy more than 30 days but less than 6 months from the initiation of AB therapy

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Male patients aged 50 years or older with a diagnostic claim for BPH; prescription claim for an AB and a 5ARI in the observation period

Key inclusion criteria (5 listed)

Male
aged 50 years or older
diagnostic claim for BPH
prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
continuously eligible for 6 months prior to and 12 months after index prescription date

Key exclusion criteria (4 listed)

prostate or bladder cancer during the study period
any prostate-related surgical procedure within 5 months of the index prescription date
prescription claim for finasteride 1 mg for male pattern baldness during the study period
5ARI therapy prior to initiation of AB therapy

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
5ARI + AB5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin	Drug	Delayed initiation of 5ARI therapy, Early initiation of 5ARI therapy

Primary outcome

Number of Participants Who Experienced Progression of Disease
Time frame: Up to 5 months
The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.

1 secondary outcome

Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery
Time frame: 6 months

Results and safety

Results posted to the registry on 29 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Treatment	5,554	5,554
Delayed Treatment	3,063	3,063

Primary outcome: Number of Participants Who Experienced Progression of Disease

Time frame: Up to 5 months. Number. Unit: participants

Measure	Early Treatment n = 5554	Delayed Treatment n = 3063
Acute Urinary Retention	589	393
Surgery	280	212
Emergency Surgery	86	52

Early Treatment vs Delayed Treatment: p = 0.002, Chi-squared
Early Treatment vs Delayed Treatment: p = 0.000, Chi-squared
Early Treatment vs Delayed Treatment: p = 0.597, Chi-squared

Population analysed: Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Treatment	0 of 0	0 of 0	Not reported
Delayed Treatment	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostatic Hyperplasia

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
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.

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 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: finished, as of the sponsor's last update on 19 Jun 2017. 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. 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?

Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Experienced Progression of Disease (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01332487.

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 19 Jun 2017.