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WEUSKOP5723: Prostate Cancer Study

8 novembre 2016 aggiornato da: GlaxoSmithKline

Prostate Cancer in Benign Prostatic Hyperplasia (BPH) Patients

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Retrospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 5-alpha reductase inhibitors
Use of 5-alpha reductase inhibitors over the course of the study period.
Altro: Alpha-blockers
Use of alpha-blockers over the study period.
Alpha-blockers
Men using alpha-blockers over the course of the study period.
Altro: 5-alpha reductase inhibitors
Use of 5-alpha reductase inhibitors over the course of the study period.
Altro: Alpha-blockers
Use of alpha-blockers over the study period.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The primary outcome is prostate cancer related mortality.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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.
Lasso di tempo: 17 years
17 years
One of the secondary outcomes is the combined endpoint of prostate cancer mortality or metastatic prostate cancer.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2012

Completamento primario (Effettivo)

1 marzo 2016

Completamento dello studio (Effettivo)

1 marzo 2016

Date di iscrizione allo studio

Primo inviato

19 dicembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

10 gennaio 2013

Primo Inserito (Stima)

14 gennaio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

9 novembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 novembre 2016

Ultimo verificato

1 novembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 116059
  • WEUSKOP5723 (Altro identificatore: GSK)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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