WEUSKOP5723: Prostate Cancer Study
Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Retrospektivní
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The primary outcome is prostate cancer related mortality.
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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.
Časové okno: 17 years
|
17 years
|
|
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One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Patologické procesy
- Novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Genitální novotvary, muži
- Onemocnění prostaty
- Novotvary prostaty
- Hyperplazie prostaty
- Hyperplazie
- Fyziologické účinky léků
- Adrenergní antagonisté
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Hormony, hormonální náhražky a antagonisté hormonů
- Antagonisté hormonů
- Inhibitory syntézy steroidů
- Adrenergní alfa-antagonisté
- Inhibitory 5-alfa reduktázy
Další identifikační čísla studie
- 116059
- WEUSKOP5723 (Jiný identifikátor: GSK)
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