Prostate enlargement - Clinical trial details 

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement

Recruitment status:
Not recruiting
Primary Sponsor:
GlaxoSmithKline
Recruitment countries:
Health condition studied:
Prostatic Hyperplasia
URL:
Link to the clinical trial website

About the trial

Interventions:
Drug: Dutasteride plus tamsulosin
Drug: tamsulosin
Key inclusion and exclusion criteria:

  • - Males aged =50 years.

    - A confirmed clinical diagnosis of BPH.

    - International Prostate Symptom Score (IPSS) 8-19 at Visit 1 (screening).

    - Prostate volume =30 cc (by transrectal ultrasonography; TRUS).

    - Total serum prostate specific antigen (PSA) =1.5 ng/mL at Visit 1 (screening).

    - Willing and able to give signed written informed consent and comply with study
    procedures.

    - Fluent and literate in local language with the ability to read, comprehend and record
    information on the IPSS and BII questionnaires.

    - Able to swallow and retain oral medication.

    - Willing and able to participate in the study for the full 2 years.

    - Men with a female partner of childbearing potential must either agree to use
    effective contraception or have had a prior vasectomy. Contraception must be used
    from 2 weeks prior to administration of the first dose of study treatment until at
    least 5 half-lives for the drug plus 3 months to allow clearance of any altered sperm
    after the last dose of study treatment.

    - French subjects: In France, a subject will be eligible for inclusion in this study
    only if either affiliated to or a beneficiary of a social security category.

    Note: If total serum PSA is >4 ng/mL and unless PSA value has been stable for at least the
    past 2 years, the investigator should make every appropriate effort to exclude the
    possibility of prostate cancer, e.g. further Digital rectal examination (DRE), review
    TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with
    routine clinical practice

    Exclusion Criteria:

    - Subjects meeting any of the following criteria must not be enrolled in the study:

    - Total serum PSA >10.0 ng/mL at Visit 1 (screening).

    - History or evidence of prostate cancer (e.g. positive biopsy or ultrasound within the
    previous 6 months, suspicious DRE and/or rising PSA).

    Excluded medication and therapies Current or any prior use of the following prohibited
    medications

    - a 5a-reductase inhibitor (finasteride or dutasteride),

    - anti-cholinergics (e.g. oxybutynin, propantheline)

    - an alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin,
    alfuzosin and doxazosin) for BPH or Lower urinary tract symptoms (LUTS)

    - any drugs with anti-androgenic properties (e.g. spironolactone, flutamide,
    bicalutamide, cimetidine, ketoconazole, progestational agents) within the previous 6
    months.

    - any drugs noted for gynaecomastia effects, or could affect prostate volume, within 6
    months of the Visit 1

    - any investigational or marketed study drug within 30 days or 5 half-lives, (whichever
    is longer), preceding the first dose of study treatment.

    Current use of:

    - any alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin,
    alfuzosin and doxazosin)

    - anabolic steroids.

    - drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and
    warfarin.

    - Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or
    predicted to need phytotherapy during the study.

    Have a known (immediate or delayed) hypersensitivity reaction or idiosyncrasy to drugs
    chemically related to the study medication or excipients that, in the opinion of the
    Investigator or GlaxoSmithKline contraindicates their participation.

    Recent Medical Procedures

    - Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and
    stent replacement) or other invasive or minimally invasive procedures to treat BPH.

    - History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7
    days prior to Visit 1 (screening). Catheterisation (<10F) is acceptable with no time
    restriction.

    Medical history

    - History of AUR within 3 months prior to Visit 1 (screening).

    - Post-void residual volume >250 mL (suprapubic ultrasound) at Visit 1 (screening)..

    - Any causes other than BPH, which may in the judgement of the investigator, result in
    urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck
    contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or
    acute or chronic urinary tract infections).

    - History of 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor
    antagonist therapy for hypertension.

    - History of postural hypotension, dizziness, vertigo or any other signs and symptoms
    of orthostasis, which in the opinion of the investigator could be exacerbated by
    tamsulosin and result in putting the subject at risk of injury.

    - History of breast cancer or clinical breast examination finding of unclear origin or
    suggestive of malignancy.

    - History of hepatic impairment or abnormal liver function tests at Visit 1
    (screening). (defined as Alanine aminotransferase (ALT), Aspartate aminotransferase
    (AST) or alkaline phosphatase >2 times the Upper limit of normal (ULN) , or total
    bilirubin >1.5 times the ULN, (unless associated with predominantly indirect
    bilirubin elevation or Gilbert's syndrome).

    - History of renal insufficiency, or serum creatinine >1.5 times the upper limit of
    normal at Visit 1 (screening)..

    - Prior history of malignancies (other than basal cell carcinoma or squamous cell
    carcinoma of the skin) within the past 5 years. Subjects who have had no evidence of
    the malignancy for =5 years are eligible.

    - History of any illness (including psychiatric) that in the opinion of the
    investigator might confound the results of the study or poses additional risk to the
    subject.

    - Any unstable, serious co-existing medical condition(s) including, but not limited to,
    myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias,
    clinically evident congestive heart failure, or cerebrovascular accident within 6
    months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which
    is uncontrolled by medical management.

    - History or current evidence of drug or alcohol abuse within the previous 12 months.

    - Any serious and/or unstable pre-existing medical, psychiatric disorder or other
    conditions that could interfere with subject's safety, obtaining informed consent or
    compliance to the study procedures, in the opinion of the Investigator or GSK Medical
    Monitor.
  • Age minimum:  50 Years
  • Age maximum:  N/A
  • Gender:  Male
Primary outcomes:
Assess the efficacy of Dutasteride plus tamsulosin treatment with lifestyle advice in providing superior symptomatic improvement to treatment naïve BPH subjects compared with watchful waiting plus lifestyle advice plus step-up therapy with tamsulosin.
Secondary outcomes:
• To assess the efficacy of Dutasteride + tamsulosin treatment with lifestyle advice in providing superior improvement in BPH-related Health Status (BHS) to BPH subjects compared with watchful waiting plus lifestyle advice plus step-up therapy with tamsu
• To assess the efficacy of Dutasteride plus tamsulosin treatment with lifestyle advice in providing superior improvement in BPH Impact Index (BII) score to BPH subjects compared with watchful wait + lifestyle advice plus step-up therapy with tamsulosin
• To assess the efficacy of Dutasteride plus tamsulosin treatment with lifestyle advice in reducing clinical progression in BPH subjects compared with watchful waiting plus lifestyle advice plus step-up therapy with tamsulosin.
Acute urinary retention related to BPH
Clinical progression is defined as any of the following:
Incontinence (overflow or urge) related to BPH.
Proportion of subjects with IPSS improvement of =2 points and =3 points from baseline and, separately, =25% improvement from baseline
Recurrent (more than one) urinary tract infection related to BPH.
Renal insufficiency related to BPH (a single =50% rise from baseline serum creatinine and a total value =1.5 mg/dL)
Symptom progression (rise in total IPSS of =3 points from baseline (Visit 2)).
To assess the efficacy of Dutasteride plus tamsulosin treatment with lifestyle advice in providing superior improvements in question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire compared with watchful waiting plus lifestyle advice
To assess the efficacy of Dutasteride plus tamsulosin treatment with lifestyle advice in providing superior improvements in question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire compared with watchful waiting plus lifestyle advice
To assess the efficacy of Dutasteride plus tamsulosin treatment with lifestyle advice in reducing BPH-related prostatic surgery in BPH subjects.
To assess the safety and tolerability of Dutasteride plus tamsulosin .
Target sample size:
742
Study type:
Interventional
Study design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Contacts:

Technical details

Scientific title:
Comparative Efficacy of Dutasteride Plus Tamulsoin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice With Step-up Therapy to Tamsulosin in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement.
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT01294592
Secondary ID:
114615
Register:
ClinicalTrials.gov
Date of registration:
10/02/2011
Date of first enrollment:
December 2010
Last refreshed:
28 April 2014

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