WEUSKOP5723: Prostate Cancer Study

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01767363

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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. This study will also assess a number of secondary endpoints including prostate cancer mortality or metastatic prostate cancer, and all cause mortality.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Other: 5-alpha reductase inhibitors Other: Alpha-blockers

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

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	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.	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.

Arm

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.

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.

Outcome Measures

Primary Outcome Measures

The primary outcome is prostate cancer related mortality. [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.

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. [17 years]
One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer. [17 years]
Metastatic prostate cancer will be identified using data recorded in cancer registries and with an algorithm based on patient medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.