Prostatic HyperplasiaNCT01386983

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

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 clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients… 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 and 5ARI + AB
How many people: 332 participants
Where: No sites listed yet
Study dates: Mar 2009to Jun 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: This study will identify eligible patient data between April 1, 2000, and December 31, 2007, and allows for patient data to be followed for 3 months prior to and up to 1 year following index prescription date.

Who may be able to join

Males
aged 50 years or older
medical claim of EP
prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
continuously eligible for 3 months prior to and at least 5 months after their index prescription date.

Who cannot join

Patients with prostate or bladder cancer
any prostate-related surgical procedure within 5 months of index date
prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB

About this study

Conditions: Prostatic Hyperplasia
Being tested: 5ARI, 5ARI + AB
Keywords: Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, acute urinary retention, surgery, early, costs, 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.

5ARIDrug
Also called Avodart® is a registered trademark of GlaxoSmithKline, Proscar® is a registered trademark of Merck
Dutasteride or Finasteride
5ARI + ABDrug
Also called Proscar® is a registered trademark of Merck, Hytrin® is a registered trademark of Abbott Laboratories, Flomax® is a registered trademark of Astellas Pharma, Avodart® is a registered trademark of GlaxoSmithKline
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin

Study groups in NCT01386983
Study group	Role	What they receive
Early 5ARI Initiation		Patients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB) Receives: Drug: 5ARI; Drug: 5ARI + AB
Late 5ARI Initiation		Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB) Receives: Drug: 5ARI; Drug: 5ARI + AB

What is being measured

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

Number of Participants With Clinical Progression
Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.
Measured: 3 months prior to and 12 months following index date

Secondary outcomes (1)

Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month
EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.
Measured: 3 months prior to and 12 months following index date

Timeline

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

Mar 2009Jun 2010

First posted1 Jul 2011 (estimated)
Study startMar 2009
Primary completionJun 2010
Study completionJun 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: 332 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01386983
Sponsor's protocol ID: 112599
Status last verified: May 2017
First submitted: 28 Feb 2011
Last updated: 17 May 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 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment
ClinicalTrials.gov ID: NCT01386983
Acronym / sponsor ID: 112599
Conditions: Prostatic Hyperplasia
Keywords: Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, acute urinary retention, surgery, early, costs, benign prostatic hyperplasia
Study type: Observational
Recruitment status: Completed
Enrolment: 332 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 1 Jul 2011 (estimated)
Results: Posted 1 Jul 2011

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 5ARI Initiation	–	Drug: 5ARI, Drug: 5ARI + ABPatients with EP receiving either 5ARI monotherapy or combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
Late 5ARI Initiation	–	Drug: 5ARI, Drug: 5ARI + ABPatients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (within 31 to 180 days after initiation of AB)

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study will identify eligible patient data between April 1, 2000, and December 31, 2007, and allows for patient data to be followed for 3 months prior to and up to 1 year following index prescription date.

Key inclusion criteria (5 listed)

Males
aged 50 years or older
medical claim of EP
prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
continuously eligible for 3 months prior to and at least 5 months after their index prescription date.

Key exclusion criteria (3 listed)

Patients with prostate or bladder cancer
any prostate-related surgical procedure within 5 months of index date
prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB

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
5ARIAlso: Avodart® is a registered trademark of GlaxoSmithKline, Proscar® is a registered trademark of MerckDutasteride or Finasteride	Drug	Early 5ARI Initiation, Late 5ARI Initiation
5ARI + ABAlso: Proscar® is a registered trademark of Merck, Hytrin® is a registered trademark of Abbott Laboratories, Flomax® is a registered trademark of Astellas Pharma, Avodart® is a registered trademark of GlaxoSmithKline5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin	Drug	Early 5ARI Initiation, Late 5ARI Initiation

Primary outcome

Number of Participants With Clinical Progression
Time frame: 3 months prior to and 12 months following index date
Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.

1 secondary outcome

Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month
Time frame: 3 months prior to and 12 months following index date

Results and safety

Results posted to the registry on 1 Jul 2011, 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 Cohort	264	264
Delayed Cohort	68	68

Primary outcome: Number of Participants With Clinical Progression

Time frame: 3 months prior to and 12 months following index date. Number. Unit: participants

Measure	Early Cohort n = 264	Delayed Cohort n = 68
Value	14	5

Early Cohort vs Delayed Cohort: Cox Proportional Hazard: 3.406 (95% CI 1.297 to 8.941), p = 0.0128, Regression, Cox

Population analysed: Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID.

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 Cohort	0 of 0	0 of 0	Not reported
Delayed Cohort	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 17 May 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 3 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 17 May 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 1 Jul 2011). 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 With Clinical Progression (time frame: 3 months prior to and 12 months following index date). 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 NCT01386983.

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 17 May 2017.