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

NCT01294592 | Completed Phase 4 Results

• 1 other identifier: 114615
• Study Type: interventional
• Target: 742
• Locations: 8 countries
• Sites: 80

Brief Summary

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the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn.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.

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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

  The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.

  Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Secondary Outcomes (10)

• 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

  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

  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

  Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

• Number of Events of Clinical Progression (CP) of BPH

  Up to 2 years

• Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH

  Up to Month 24

Study Arms (2)

Dutasteride plus tamsulosin

ACTIVE COMPARATOR

Dutasteride plus tamsulosin arm + lifestyle advice

Drug: Dutasteride plus tamsulosin

Watchful waiting with escalation to tamsulosin

EXPERIMENTAL

Watchful waiting with escalation to tamsulosin

Drug: tamsulosin

Interventions

Dutasteride plus tamsulosin DRUG

Take 1 capsule daily

Dutasteride plus tamsulosin

tamsulosin DRUG

Take 1 capsule daily when escalation criteria met

Watchful waiting with escalation to tamsulosin

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (80)

GSK Investigational Site

Aigrefeuille-sur-Maine, 44140, France

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GSK Investigational Site

Angers, 49000, France

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GSK Investigational Site

Angers, 49933, France

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GSK Investigational Site

Corsept, 44560, France

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GSK Investigational Site

La Montagne, 44620, France

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GSK Investigational Site

La Rochelle, 17000, France

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GSK Investigational Site

Laval, 53000, France

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GSK Investigational Site

Le Temple-de-Bretagne, 44360, France

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GSK Investigational Site

Mûrs-Erigné, 49610, France

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GSK Investigational Site

Nantes, 44300, France

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GSK Investigational Site

Nieul-sur-Mer, 17137, France

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GSK Investigational Site

Sautron, 44880, France

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GSK Investigational Site

Thouars, 79100, France

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GSK Investigational Site

Tiercé, 49125, France

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GSK Investigational Site

Vihiers, 49310, France

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GSK Investigational Site

Aichach, Bavaria, 86551, Germany

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GSK Investigational Site

Nuremberg, Bavaria, 90441, Germany

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GSK Investigational Site

Hagenow, Brandenburg, 19230, Germany

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GSK Investigational Site

Oranienburg, Brandenburg, 16515, Germany

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GSK Investigational Site

Strausberg, Brandenburg, 15344, Germany

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GSK Investigational Site

Marburg, Hesse, 35039, Germany

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GSK Investigational Site

Buchholz, Lower Saxony, 21244, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45130, Germany

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GSK Investigational Site

Leipzig, Saxony, 04109, Germany

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GSK Investigational Site

Hettstedt, Saxony-Anhalt, 06333, Germany

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GSK Investigational Site

Kiel, Schleswig-Holstein, 24143, Germany

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GSK Investigational Site

Berlin, 10249, Germany

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GSK Investigational Site

Eisleben Lutherstadt, 06295, Germany

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GSK Investigational Site

Argos, 21200, Greece

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GSK Investigational Site

Athens, 10552, Greece

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GSK Investigational Site

Athens, 115 22, Greece

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GSK Investigational Site

Athens, 11527, Greece

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GSK Investigational Site

Athens, 151 26, Greece

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GSK Investigational Site

Larissa, 41110, Greece

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GSK Investigational Site

Pátrai, 265 04, Greece

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GSK Investigational Site

Rhodes, 85100, Greece

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GSK Investigational Site

Thessaloniki, 546 42, Greece

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GSK Investigational Site

Thessaloniki, 564 29, Greece

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GSK Investigational Site

Vasto (CH), Abruzzo, 66054, Italy

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GSK Investigational Site

Foggia, Apulia, 71100, Italy

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GSK Investigational Site

Avellino, Campania, 83100, Italy

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GSK Investigational Site

Napoli, Campania, 80131, Italy

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GSK Investigational Site

Rome, Lazio, 00161, Italy

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GSK Investigational Site

Milan, Lombardy, 20132, Italy

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GSK Investigational Site

San Fermo Della Battaglia (CO), Lombardy, 22020, Italy

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GSK Investigational Site

Turin, Piedmont, 10126, Italy

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GSK Investigational Site

Cagliari, Sardinia, 09134, Italy

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GSK Investigational Site

Pisa, Tuscany, 56124, Italy

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GSK Investigational Site

Doetinchem, 7009 BL, Netherlands

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GSK Investigational Site

Maarssen, 3607 KN, Netherlands

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GSK Investigational Site

Sneek, 8601 ZK, Netherlands

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GSK Investigational Site

The Hague, 2582 LJ, Netherlands

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GSK Investigational Site

Voerendaal, 6367 ED, Netherlands

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GSK Investigational Site

Wildervank, 9648 BE, Netherlands

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GSK Investigational Site

Winterswijk, 7101 BN, Netherlands

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GSK Investigational Site

Arad, 310175, Romania

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GSK Investigational Site

Bucharest, Romania

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GSK Investigational Site

Alava, 01004, Spain

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GSK Investigational Site

Barcelona, 8907, Spain

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GSK Investigational Site

Coslada, 28822, Spain

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GSK Investigational Site

Córdoba, 14004, Spain

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GSK Investigational Site

Fuenlabrada (Madrid), 28942, Spain

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GSK Investigational Site

Galdakano, 48960, Spain

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GSK Investigational Site

Getafe, 28905, Spain

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GSK Investigational Site

Marbella, 29600, Spain

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GSK Investigational Site

Málaga, 29010, Spain

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GSK Investigational Site

Mendaro, Guipuzcoa, 20850, Spain

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GSK Investigational Site

Murcia, 30008, Spain

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GSK Investigational Site

Pamplona, 31008, Spain

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GSK Investigational Site

San Sebastián, 20014, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Valladolid, 47012, Spain

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GSK Investigational Site

Chalfont St Giles, Buckinghamshire, HP8 4QG, United Kingdom

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GSK Investigational Site

Sandbach, Cheshire, CW11 1EQ, United Kingdom

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GSK Investigational Site

Bath, BA1 3NG, United Kingdom

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GSK Investigational Site

Bristol, BS2 8HW, United Kingdom

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GSK Investigational Site

Broadway, Fleetwood, FY7 8GU, United Kingdom

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GSK Investigational Site

Chadderton, Oldham, OL9 0LH, United Kingdom

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GSK Investigational Site

Glasgow, G51 4TF, United Kingdom

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GSK Investigational Site

High Heaton, Newcastle Upon Tyne, NE7 7DN, United Kingdom

Location

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride; Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: December 22, 2010
• Primary Completion: October 17, 2013
• Study Completion: October 17, 2013
• Last Updated: August 20, 2018
• Results First Posted: June 16, 2014

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

FR (15); DE (13); NL (7); GB (8); GR (10); IT (10); RO (2); ES (15)