Prostatic HyperplasiaNCT01767363
WEUSKOP5723: Prostate Cancer Study
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
Trial summary
This retrospective cohort study will assess the association of benign prostatic hyperplasia (BPH) treatment (5-alpha reductase inhibitors (5ARI) and alpha-blocker medications) with the occurrence of prostate cancer related mortality. 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?
- 5-alpha reductase inhibitors and Alpha-blockers
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Mar 2016
- 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: All men age 50 years and older treated with a BPH medication (5ARI and/or alpha-blocker) will be eligible for inclusion. Participants are not required to have a BPH diagnosis at the time of their first 5ARI or alpha-blocker prescription as based upon data from the feasibility report approximately half of all men received their first recorded BPH diagnosis after initiating treatment. Furthermore, approximately 25% of participants treated with 5ARIs or alpha-blockers did not have a diagnosis code for BPH in their medical record. BPH diagnosis codes were not used in a consistent way historically in the Kaiser data. Men should have coverage within the healthcare system for at least 1-year before the first BPH medication prescription. Men with a history of prostate cancer or who develop prostate cancer within <3 months of starting their first BPH medication are not eligible for inclusion.
Who may be able to join
- Patients that are Male
- Patients that have a new prescription for BPH medication (5ARI and/or alpha-blocker) in 1992 or later that is identified as appropriate treatment for BPH/LUTS from the KP National Pharmacy guidelines.
- Patients with a treatment with BPH medication must be initiated prior to Jan1, 2008.
- Patients age 50 years or older at time of treatment with 5ARI or alpha-blocker.
- Patients with at least 1-year of coverage in the healthcare system before the first prescription for BPH medication (5ARI and/or alpha-blocker).
- Patients with at least 3 consecutive prescriptions (90 days of supply) for a BPH medication (5ARI and/or alpha-blocker).
Who cannot join
- Patients with a diagnosis of prostate cancer any time before the first prescription for BPH medication (5ARI and/or alpha-blocker).
- Patients with a dagnosis of prostate cancer within 3 months after first BPH medication (5ARI and/or alpha-blocker)
- Patients treated with Finasteride 1mg prior to BPH medication. Finasteride 1mg is the dose approved for androgenic alopecia and as the target population for this study is men with treated BPH, we will exclude all men treated with the 1mg dose.
About this study
Official title: Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients
This retrospective cohort study will assess the association of benign prostatic hyperplasia (BPH) treatment (5-alpha reductase inhibitors (5ARI) and alpha-blocker medications) with the occurrence of prostate cancer related mortality. This study will also assess a number of secondary endpoints including prostate cancer mortality or metastatic prostate cancer, and all cause mortality.
Read the detailed description
A retrospective cohort study from 1992-2010 will be conducted using data from 4 Kaiser sites: Kaiser Permanente Southern California (KPSC), Kaiser Permanente Northern California (KPNC), Kaiser Permanente Northwest (KPNW), and Kaiser Permanente Colorado (KPCO). Men treated with BPH medications, 5ARIs (with and without concomitant and/or previous alpha-blocker use) will be compared to men treated with alpha-blockers. A matched design will be used with each man treated with 5ARIs being matched with 5 or 6 men treated with alpha-blockers. Men 50 years or older at the time of their first prescription for a study defined BPH medication, initiating treatment between 1992 and 2008 with at least 1-year of coverage in the healthcare system before the first prescription for BPH medication and at least 3 consecutive prescriptions (90 days of supply) for a BPH medication will be eligible for inclusion in the study. Men with a diagnosis of prostate cancer any time before the first prescription for BPH medication, having a diagnosis of prostate cancer within 3 months after initiation of their first BPH medication, and those treated with finasteride 1mg prior to their BPH medication will be excluded from the study. 5ARI initiators will be matched to alpha-blocker users in a ratio of 1:5 or 1:6 to yield an overall matching ratio of 1:5.4. Matching factors include age (+/- 1 year), timing of BPH treatment initiation (+/- 1 year), race, and duration of prior use of alpha-blockers. Based on the feasibility study from KPSC, there will be approximately 284,000 men treated with BPH medications meeting eligibility criteria for inclusion in the study sample.
The data will be analyzed using Kaplan Meier curves comparing the 5ARI vs alpha-blocker users for the primary and secondary study outcomes, without any adjustments. Additionally, a plot of cumulative incidence, adjusting for competing risks of death, will be constructed allowing for the investigation of the effect of competing risks on the Kaplan-Meier probability estimates. Crude mortality rates and incidence rates of metastatic cancer will be calculated. Cox proportional hazard regression models will be fit to compare the primary and secondary outcomes between groups using hazard ratios, while adjusting for pre-treatment characteristics.
- Conditions
- Prostatic Hyperplasia
- Being tested
- 5-alpha reductase inhibitors, Alpha-blockers
- Keywords
- 5-alpha reductase inhibitor, benign prostatic hyperplasia treatment, Prostate cancer mortality
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-alpha reductase inhibitorsOther
Use of 5-alpha reductase inhibitors over the course of the study period.
Alpha-blockersOther
Use of alpha-blockers over the study period.
| Study group | Role | What they receive |
|---|---|---|
| 5-alpha reductase inhibitors with or without alpha-blockers | Men using 5-alpha reductase inhibitors with or without alpha-blockers over the course of the study period. Receives: Other: 5-alpha reductase inhibitors; Other: Alpha-blockers | |
| Alpha-blockers | Men using alpha-blockers over the course of the study period. Receives: Other: 5-alpha reductase inhibitors; Other: Alpha-blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is prostate cancer related mortality.
Cause of death codes from death certificates, along with an electronic algorithm using pre-defined decision points, will be used to classify cause of death. Chart review will be performed to further validate cause of death.
Measured: 17 years
Secondary outcomes (2)
One of the secondary outcomes is all cause mortality. Death information will be derived from several sources including membership files, state death records and the Social Security Index.
Measured: 17 years
One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer.
Metastatic prostate cancer will be identified using data recorded in cancer registries and with an algorithm based on patient medical records.
Measured: 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767363
- Sponsor's protocol ID
- 116059
- Other IDs
- WEUSKOP5723
- Status last verified
- Nov 2016
- First submitted
- 19 Dec 2012
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients
- ClinicalTrials.gov ID
- NCT01767363
- Acronym / sponsor ID
- 116059
- Conditions
- Prostatic Hyperplasia
- Keywords
- 5-alpha reductase inhibitor, benign prostatic hyperplasia treatment, Prostate cancer mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jan 2013 (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.
This retrospective cohort study will assess the association of benign prostatic hyperplasia (BPH) treatment (5-alpha reductase inhibitors (5ARI) and alpha-blocker medications) with the occurrence of prostate cancer related mortality. This study will also assess a number of secondary endpoints including prostate cancer mortality or metastatic prostate cancer, and all cause mortality.
Detailed description
A retrospective cohort study from 1992-2010 will be conducted using data from 4 Kaiser sites: Kaiser Permanente Southern California (KPSC), Kaiser Permanente Northern California (KPNC), Kaiser Permanente Northwest (KPNW), and Kaiser Permanente Colorado (KPCO). Men treated with BPH medications, 5ARIs (with and without concomitant and/or previous alpha-blocker use) will be compared to men treated with alpha-blockers. A matched design will be used with each man treated with 5ARIs being matched with 5 or 6 men treated with alpha-blockers. Men 50 years or older at the time of their first prescription for a study defined BPH medication, initiating treatment between 1992 and 2008 with at least 1-year of coverage in the healthcare system before the first prescription for BPH medication and at least 3 consecutive prescriptions (90 days of supply) for a BPH medication will be eligible for inclusion in the study. Men with a diagnosis of prostate cancer any time before the first prescription for BPH medication, having a diagnosis of prostate cancer within 3 months after initiation of their first BPH medication, and those treated with finasteride 1mg prior to their BPH medication will be excluded from the study. 5ARI initiators will be matched to alpha-blocker users in a ratio of 1:5 or 1:6 to yield an overall matching ratio of 1:5.4. Matching factors include age (+/- 1 year), timing of BPH treatment initiation (+/- 1 year), race, and duration of prior use of alpha-blockers. Based on the feasibility study from KPSC, there will be approximately 284,000 men treated with BPH medications meeting eligibility criteria for inclusion in the study sample.
The data will be analyzed using Kaplan Meier curves comparing the 5ARI vs alpha-blocker users for the primary and secondary study outcomes, without any adjustments. Additionally, a plot of cumulative incidence, adjusting for competing risks of death, will be constructed allowing for the investigation of the effect of competing risks on the Kaplan-Meier probability estimates. Crude mortality rates and incidence rates of metastatic cancer will be calculated. Cox proportional hazard regression models will be fit to compare the primary and secondary outcomes between groups using hazard ratios, while adjusting for pre-treatment characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-alpha reductase inhibitors with or without alpha-blockers | – | Other: 5-alpha reductase inhibitors, Other: Alpha-blockersMen using 5-alpha reductase inhibitors with or without alpha-blockers over the course of the study period. |
| Alpha-blockers | – | Other: 5-alpha reductase inhibitors, Other: Alpha-blockersMen using alpha-blockers over the course of the study period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All men age 50 years and older treated with a BPH medication (5ARI and/or alpha-blocker) will be eligible for inclusion. Participants are not required to have a BPH diagnosis at the time of their first 5ARI or alpha-blocker prescription as based upon data from the feasibility report approximately half of all men received their first recorded BPH diagnosis after initiating treatment. Furthermore, approximately 25% of participants treated with 5ARIs or alpha-blockers did not have a diagnosis code for BPH in their medical record. BPH diagnosis codes were not used in a consistent way historically in the Kaiser data. Men should have coverage within the healthcare system for at least 1-year before the first BPH medication prescription. Men with a history of prostate cancer or who develop prostate cancer within <3 months of starting their first BPH medication are not eligible for inclusion.
Key inclusion criteria (6 listed)
- Patients that are Male
- Patients that have a new prescription for BPH medication (5ARI and/or alpha-blocker) in 1992 or later that is identified as appropriate treatment for BPH/LUTS from the KP National Pharmacy guidelines.
- Patients with a treatment with BPH medication must be initiated prior to Jan1, 2008.
- Patients age 50 years or older at time of treatment with 5ARI or alpha-blocker.
- Patients with at least 1-year of coverage in the healthcare system before the first prescription for BPH medication (5ARI and/or alpha-blocker).
Key exclusion criteria (3 listed)
- Patients with a diagnosis of prostate cancer any time before the first prescription for BPH medication (5ARI and/or alpha-blocker).
- Patients with a dagnosis of prostate cancer within 3 months after first BPH medication (5ARI and/or alpha-blocker)
- Patients treated with Finasteride 1mg prior to BPH medication. Finasteride 1mg is the dose approved for androgenic alopecia and as the target population for this study is men with treated BPH, we will exclude all men treated with the 1mg dose.
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 |
|---|---|---|
| 5-alpha reductase inhibitorsUse of 5-alpha reductase inhibitors over the course of the study period. | Other | 5-alpha reductase inhibitors with or without alpha-blockers, Alpha-blockers |
| Alpha-blockersUse of alpha-blockers over the study period. | Other | 5-alpha reductase inhibitors with or without alpha-blockers, Alpha-blockers |
Primary outcome
The primary outcome is prostate cancer related mortality.
Time frame: 17 years
Cause of death codes from death certificates, along with an electronic algorithm using pre-defined decision points, will be used to classify cause of death. Chart review will be performed to further validate cause of death.
2 secondary outcomes
One of the secondary outcomes is all cause mortality. Death information will be derived from several sources including membership files, state death records and the Social Security Index.
Time frame: 17 years
One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer.
Time frame: 17 years
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 9 Nov 2016.
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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.
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 6 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 9 Nov 2016. 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?
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?
The primary outcome is prostate cancer related mortality. (time frame: 17 years). 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 9 Nov 2016; AzTrials last refreshed its copy on 29 Oct 2026.