Last updated: 12/03/2023 09:10:20

Development of Benign Prostatic Hyperplasia (BPH) progression risk calculator

GSK study ID
209708
See study documents
Clinicaltrials.gov ID
Not applicable
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: Development of BPH progression risk calculator based on GSK-sponsored Dutasteride studies
Trial description: Over the last several years, many clinical trials and findings have been published to guide the optimal medical management of men with increased risk of BPH, the wealth and complexity of clinical trial data also make it difficult to establish a personalized treatment strategy. An easily accessible tool, that accounts for individual measurements and provides tangible and treatment-specific risk estimates, will be beneficial to physicians and allow for better informed medical treatment decisions. This study will be conducted to build a predictive model that will estimate the personalized risk of symptom deterioration and acute urinary retention (AUR) or BPH-related surgery in subjects who are at risk of disease progression (i.e. age greater than or equal to 50 years, moderate to severe lower urinary tract symptoms (LUTS), prostate volume (PV) greater than or equal to 30 milliliter (mL) and prostate specific antigen (PSA) greater than or equal to 1.5 nanograms per milliliter (ng/mL), with and without therapeutic intervention (Tamsulosin, Dutasteride or combination treatment). The study will be predictive modeling based on data (re-use) from 10 GlaxoSmithKline (GSK) sponsored phase III and IV Dutasteride clinical trials. All the studies which are considered to be included in this meta-analysis are completed and published and vary in length between 36 weeks to 4 years.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects with risk of symptom deterioration and AUR or BPH-related surgery

Timeframe: Upto 4 years

Time to disease progression

Timeframe: Upto 4 years

Increase in International prostate symptom (IPSS) score

Timeframe: Upto 4 years

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Placebo
  • Drug: Finasteride 5 mg
  • Drug: Dutasteride 0.5 mg
  • Drug: Tamsulosin 0.2 mg
  • Drug: Tamsulosin 0.4 mg
  • Drug: Dutasteride 0.5 mg and Tamsulosin 0.2 mg
  • Drug: Dutasteride 0.5 mg and Tamsulosin 0.4 mg
    • Enrollment:
    Not applicable
    Primary completion date:
    2021-20-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Stavros Gravas, Juan Manuel-Palacios, Douglas Thompson, Federico Concas, Piotr J. Kamola, Claus G. Roehrborn, Matthias Oelke, Michael W. Kattan, Marcio Augusto Averbeck, Michael Manyak, Vanessa Cortes, and Zrinka Lulic. Understanding Treatment Response in Individual Profiles of Men with Prostatic Enlargement at Risk of Progression. Eur Urol Focus. 2022; DOI: 10.1016/j.euf.2022.07.004 PMID: NULL
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride, dutasteride/tamsulosin, tamsulosin
    Collaborators
    Not applicable
    Study date(s)
    February 2019 to May 2021
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • All subjects within the studies of interest will be included, as the clinical trials eligibility match that of the predictive modeling efforts
    • Some studies might be excluded from the final analysis in case of significantly divergent characteristics (e.g. disproportionate number of symptom deterioration events)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • All subjects within the studies of interest will be included, as the clinical trials eligibility match that of the predictive modeling efforts
    Exclusion criteria:
    • Some studies might be excluded from the final analysis in case of significantly divergent characteristics (e.g. disproportionate number of symptom deterioration events)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2021-20-05
    Actual study completion date
    2021-20-05

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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