Clinical trial · Observational

WEUSKOP5723: Prostate Cancer Study

Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients

NCT01767363CI-TRIAL-00024766completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostatic Hyperplasia	Benign Prostatic Hyperplasia	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
5-alpha reductase inhibitors	Other	—	UNRESOLVED
Alpha-blockers	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
5-alpha reductase inhibitors with or without alpha-blockers
description
Men using 5-alpha reductase inhibitors with or without alpha-blockers over the course of the study period.
interventionNames
1. Other: 5-alpha reductase inhibitors
2. Other: Alpha-blockers
label
Alpha-blockers
description
Men using alpha-blockers over the course of the study period.
interventionNames
1. Other: 5-alpha reductase inhibitors
2. Other: Alpha-blockers

Primary outcomes (1)

measure
The primary outcome is prostate cancer related mortality.
timeFrame
17 years
description

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 50 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.