Last updated: 11/07/2018 07:59:57
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 enlargementCONDUCT
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Comparative efficacy of DuodartTM versus watchful waiting with step-up therapy to tamsulosin in the management of treatment naïve men with symptomatic BPH
Trial description: Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH). Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire.After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in the total International Prostate Symptom score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the last observation carried forward (LOCF) approach
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Secondary outcomes:
Number of participants with change from Baseline in the indicated improvement categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Change from Baseline in the BPH Impact Index (BII) score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Change from Baseline in the BPH-related Health Status (BHS) score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Number of events of clinical progression (CP) of BPH
Timeframe: Up to 2 years
Number of participants with the indicated first-occurring component of clinical progression (CP) of BPH
Timeframe: Up to Month 24
Number of participants who had any BPH-related surgery, who had the indicated type of surgery, who had 2 BPH-related surgeries, and who had >=3 BPH-related surgeries
Timeframe: Up to Month 24
Number of participants with the indicated responses to Question 1 of the Patient Perception of Study Treatment (PPST) questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Number of participants with the indicated responses to Question 2 of the Patient Perception of Study Treatment (PPST) questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 using the LOCF approach
Timeframe: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Exposure to study drug
Timeframe: Up to 2 years
Number of participants with any adverse event (AE) or serious adverse event (SAE) starting post-randomization
Timeframe: Up to 2 years
Interventions:
Enrollment:
742
Primary completion date:
2013-17-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Claus G. Roehrborn, Igor Oyarzabal Perez, Erik P.M. Roos, Nicolae Calomfirescu, Betsy Brotherton, Fang Wang, Juan Manuel Palacios, Averyan Vasylyev and Michael J. Manyak. Efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin treatment (Duodart™) compared with watchful waiting with initiation of tamsulosin therapy if symptoms do not improve, both provided with lifestyle advice, in the management of treatment-naïve men with moderately symptomatic benign prostatic hyperplasia: 2-Year CONDUCT study results. BJU Int. 2015;116(3):450-459.
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
December 2010 to October 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- Males aged ≥50 years.
- A confirmed clinical diagnosis of BPH.
Inclusion and exclusion criteria
Inclusion 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 5α-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.
Trial location(s)
Location
GSK Investigational Site
Buchholz, Niedersachsen, Germany, 21244
Status
Study Complete
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-17-10
Actual study completion date
2013-17-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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