- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767363
WEUSKOP5723: Prostate Cancer Study
Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Use of 5-alpha reductase inhibitors over the course of the study period.
Use of alpha-blockers over the study period.
|
Alpha-blockers
Men using alpha-blockers over the course of the study period.
|
Use of 5-alpha reductase inhibitors over the course of the study period.
Use of alpha-blockers over the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
17 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
17 years
|
|
One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer.
Time Frame: 17 years
|
Metastatic prostate cancer will be identified using data recorded in cancer registries and with an algorithm based on patient medical records.
|
17 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Adrenergic alpha-Antagonists
- 5-alpha Reductase Inhibitors
Other Study ID Numbers
- 116059
- WEUSKOP5723 (Other Identifier: GSK)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostatic Hyperplasia
-
GlaxoSmithKlineCompletedBenign Prostatic Hyperplasia
-
St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareCompletedBenign Prostatic HyperplasiaCanada
-
Assiut UniversityNot yet recruiting
-
NeoTract, Inc.Not yet recruitingBenign Prostatic Hyperplasia
-
Assiut UniversityNot yet recruitingBenign Prostatic Hyperplasia
-
Second Affiliated Hospital, School of Medicine,...RecruitingBenign Prostatic HyperplasiaChina
-
Jewish General HospitalNot yet recruitingBenign Prostatic Hyperplasia
-
Zenflow, Inc.RecruitingBenign Prostatic HyperplasiaAustralia, New Zealand
-
REMD Medical TechnologyRenJi Hospital; Tongji Hospital; Qilu Hospital of Shandong University; Sun Yat-Sen... and other collaboratorsCompletedBenign Prostatic HyperplasiaChina
-
Bioaraba Health Research InstituteCompletedBenign Prostatic HyperplasiaSpain
Clinical Trials on 5-alpha reductase inhibitors
-
Boston Scientific CorporationRecruitingBenign Prostatic Hyperplasia (BPH)France, Australia
-
Samsung Medical CenterCompletedBenign Prostatic HyperplasiaKorea, Republic of
-
GlaxoSmithKlineCompleted
-
Mylan Pharmaceuticals IncCompleted
-
Mylan Pharmaceuticals IncCompleted
-
Dongkook Pharmaceutical Co., Ltd.CompletedBenign Prostate HyperplasiaKorea, Republic of
-
Teva Pharmaceuticals USACompleted
-
Actavis Inc.Completed
-
GlaxoSmithKlineCompleted