5ARI and Prostate Cancer Mortality Study (116059)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48165
• EU PAS number:
  EUPAS4129
• Study ID:
  48165
• Official title and acronym:
  5ARI and Prostate Cancer Mortality Study (116059)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  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.
• Study status:
  Finalised

Research institution and networks

Institutions

Kaiser Permanente Southern California (KPSC)

Study timelines

Date when funding contract was signed

Actual: 15/11/2012

Study start date

Actual: 15/11/2012

Date of interim report, if expected

Planned: 28/02/2015

Date of final study report

Planned: 31/03/2016

Actual: 31/03/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline, LLC

Study protocol

Initial protocol

Redacted Final Avodart Mortality Protocol 11 15 12_116059 pdf draft 001_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable