Last updated: 03/22/2021 15:30:07

WEUSKOP5723: Prostate Cancer Study

GSK study ID
116059
See study documents
Clinicaltrials.gov ID
NCT01767363
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Prostate Cancer in Benign prostatic hyperplasia (BPH) patients
Trial 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The primary outcome is prostate cancer related mortality.

Timeframe: 17 years

Secondary outcomes:

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.

Timeframe: 17 years

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

Timeframe: 17 years

Interventions:
  • Other: 5-alpha reductase inhibitors
  • Other: Alpha-blockers
    • Enrollment:
    1
    Primary completion date:
    2016-31-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Lauren P. Wallner, Julia R. DiBello, Bonnie H. Li, Stephen K. Van Den Eeden, Sheila Weinmann, Debra P. Ritzwoller, Jill E. Abel, Ralph D’Agostino Jr, Ronald K. Loo, David S. Aaronson, Kathryn Richert-Boe, Ralph I Horwitz, Steven J. Jacobsen. 5-alpha reductase inhibitors and the risk of prostate cancer mortality . Mayo Clin Proc. 2016;91(12):1717-1726.
    Lauren P. Wallner, Julia R. DiBello, Bonnie H. Li, Stephen K. Van Den Eeden, Sheila Weinmann, Debra P. Ritzwoller, Jill E. Abel, Ralph D’Agostino Jr, Ronald K. Loo, David S. Aaronson, Ralph I Horwitz, Steven J. Jacobsen.The use of 5-alpha reductase inhibitors to manage benign prostatic hyperplasia and the risk of all-cause mortality.Urology.2018;S0090-4295(18):30553-3 DOI: 10.1016/j.urology.2018.05.033 PMID: 29906480
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride, dutasteride/tamsulosin, tamsulosin
    Collaborators
    Not applicable
    Study date(s)
    November 2012 to March 2016
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • 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 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)
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2016-31-03
    Actual study completion date
    2016-31-03

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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