WEUSKOP5723: Prostate Cancer Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01767363
First received: December 19, 2012
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Prostatic Hyperplasia
Other: 5-alpha reductase inhibitors
Other: Alpha-blockers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The primary outcome is prostate cancer related mortality. [ Time Frame: 17 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer. [ Time Frame: 17 years ] [ Designated as safety issue: Yes ]
    Metastatic prostate cancer will be identified using data recorded in cancer registries and with an algorithm based on patient medical records.


Estimated Enrollment: 1
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: 5-alpha reductase inhibitors
Use of 5-alpha reductase inhibitors over the course of the study period.
Other: Alpha-blockers
Use of alpha-blockers over the study period.
Alpha-blockers
Men using alpha-blockers over the course of the study period.
Other: 5-alpha reductase inhibitors
Use of 5-alpha reductase inhibitors over the course of the study period.
Other: Alpha-blockers
Use of alpha-blockers over the study period.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767363

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01767363     History of Changes
Other Study ID Numbers: 116059, WEUSKOP5723
Study First Received: December 19, 2012
Last Updated: April 17, 2014
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
5-alpha reductase inhibitor
benign prostatic hyperplasia treatment
Prostate cancer mortality

Additional relevant MeSH terms:
Prostatic Neoplasms
Hyperplasia
Prostatic Hyperplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pathologic Processes
5-alpha Reductase Inhibitors
Adrenergic alpha-Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014