Last updated: 02/18/2024 18:00:15

Early versus delayed combination treatment: Follow up analysis of the Dutasteride Drug Disease Model on acute urinary retention (AUR) and risk of benign prostate hyperplasia (BPH) surgery

GSK study ID
209707
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: Reporting and analysis plan for modelling and simulation of the time to acute urinary retention (AUR) or BPH-related surgery after early vs. delayed onset of combination therapy with tamsulosin and dutasteride
Trial description: This meta-analysis will utilize a model-based approach to analyze individual subject level data from randomized clinical trials and follow up studies with the different treatment regimens to characterize the time to first AUR or BPH-related surgery. The availability of such a model will provide the basis for subsequent evaluation of the effect of delayed start of combined therapy. Data from study ARIA3001, ARIA3002, ARI40002, ARIB3003, CombAT and CONDUCT will be used for the development and internal validation of the time to first event model for AUR or BPH-related surgery. Using the final time to event model, clinical simulation scenarios will be implemented to evaluate the impact of different treatment interventions on time to AUR or BPH-related surgery.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Time to AUR or BPH-related surgical intervention

Timeframe: Up to 48 months

Incidence of AUR or BPH related surgical intervention

Timeframe: Up to 48 months

Increase in time to AUR or BPH-related surgery due to combination therapy

Timeframe: Up to 48 months

Relative risk of AUR or BPH-related surgery

Timeframe: Up to 48 months

Risk associated with delayed onset of treatment with tamsulosin and dutasteride combination therapy

Timeframe: Up to 48 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Tamsulosin monotherapy
  • Drug: Dutasteride+tamsulosin combination therapy
    • Enrollment:
    0
    Primary completion date:
    2019-01-04
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    December 2018 to April 2019
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Data from subjects who received tamsulosin and dutasteride combination therapy, tamsulosin monotherapy, dutasteride monotherapy, watchful waiting with protocol-defined initiation of tamsulosin monotherapy or placebo in studies ARIA3001, ARIA3002, ARI40002, ARIB3003, CombAT and CONDUCT will be included in the analysis.
    • Men >=50 years of age.
    • History or evidence of prostate cancer.
    • Previous prostatic surgery.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Data from subjects who received tamsulosin and dutasteride combination therapy, tamsulosin monotherapy, dutasteride monotherapy, watchful waiting with protocol-defined initiation of tamsulosin monotherapy or placebo in studies ARIA3001, ARIA3002, ARI40002, ARIB3003, CombAT and CONDUCT will be included in the analysis.
    • Men >=50 years of age.
    • An International Prostate Symptom Score (IPSS) >=8 points, prostate volume>=30 milliliter (mL), total serum prostate specific antigen (PSA) >=1.5 nanogram per milliliter (ng/mL) and <10 ng/mL, a maximum urine flow >5 milliliter per second (mL/s) and <=15 mL/s and a minimum voided volume >=125 mL.
    Exclusion criteria:
    • History or evidence of prostate cancer.
    • Previous prostatic surgery.
    • History of acute urinary retention within 3 months prior to study entry.
    • 5-alpha reductase inhibitor (5-ARI) use within 6 months (or dutasteride within 12 months) prior to entry or use of an alpha-blocker or phytotherapy for BPH within 2 weeks prior to entry.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    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
    2019-01-04
    Actual study completion date
    2019-01-04

    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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