WEUSKOP5723: Prostate Cancer Study

NCT01767363 | Completed

• 2 other identifiers: 116059WEUSKOP5723
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Hyperplasia

Keywords

5-alpha reductase inhibitor; benign prostatic hyperplasia treatment; Prostate cancer mortality

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  17 years

• One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer.

  17 years

Study Arms (2)

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; Other: Alpha-blockers

Alpha-blockers

Men using alpha-blockers over the course of the study period.

Other: 5-alpha reductase inhibitors; Other: Alpha-blockers

Interventions

5-alpha reductase inhibitors OTHER

Use of 5-alpha reductase inhibitors over the course of the study period.

5-alpha reductase inhibitors with or without alpha-blockers; Alpha-blockers

Alpha-blockers OTHER

Use of alpha-blockers over the study period.

5-alpha reductase inhibitors with or without alpha-blockers; Alpha-blockers

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

5-alpha Reductase Inhibitors; Adrenergic alpha-Antagonists

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: January 14, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 9, 2016

Record last verified: 2016-11