A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) (DELUTS)

A Dose-Finding, Multi-Centre, Double-Blind, Randomised, Parallel, Placebo-Controlled Trial to Investigate Efficacy and Safety of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms (LUTS)
• Intervention / Treatment: Drug: Placebo; Drug: Degarelix 10 mg; Drug: Degarelix 20 mg; Drug: Degarelix 30 mg

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Middelheim Antwerp
  • Brussels, Belgium
    • UZ Brussel
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada
      • Can-Med Clinical Research Inc
    • Victoria, British Columbia, Canada
      • Dr Steinhoff Clinical Research
  • Ontario
    • Barrie, Ontario, Canada
      • Male/Female Health and Research Centre
    • Brampton, Ontario, Canada
      • Bramalea Medical Centre
    • Brantford, Ontario, Canada
      • Brandford Urology Research
    • Guelph, Ontario, Canada
      • Guelp Urology
    • Kingston, Ontario, Canada
      • Centre for Applied Urological Research
    • North Bay, Ontario, Canada
      • Investigational Site
    • Oakville, Ontario, Canada
      • Female/Male Health Centres
    • Ottawa, Ontario, Canada
      • Mahoney Medicine Professional Corporation
    • Owen Sound, Ontario, Canada
      • Todd Webster Ontario Inc
    • Thunder Bay, Ontario, Canada
      • Anthony Skehan Medicine Professional Corporation
    • Toronto, Ontario, Canada
      • The Male Health Centre
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University Health Centre
    • Point-Claire, Quebec, Canada
      • Ultra-Med Inc
• Czech Republic
  • Benesov, Czech Republic
    • Urologie, Male namesti 1783
  • Brno, Czech Republic
    • Urocentrum Brno, Purkynova 35e
  • Hradec Králové, Czech Republic
    • Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220
  • Litomerice, Czech Republic
    • Urologicka ambulance, Litomerice (Halek)
  • Opava, Czech Republic
    • Slezska nemocnice, prospevkova organizace, Urologicke oddeleni
  • Praha, Czech Republic
    • Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289
  • Praha, Czech Republic
    • Urocentrum, Karlovo namesti 3
  • Praha, Czech Republic
    • Urologica ambulance, Praha 10
  • Ústi nad Labem, Czech Republic
    • Ústecké urocentrum, Ústi nad Labem (Liehne)
• Italy
  • Avellino, Italy
    • Urologia, A.O. San Giuseppe Moscati, Avellino
  • Milano, Italy
    • Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco
  • Milano, Italy
    • Unità Operativa di Urologia, Ospedale San Raffaele
• Poland
  • Gdansk, Poland
    • Akademia Medyczna W Gdansku
  • Inowroclaw, Poland
    • Publiczny Specjalistyczny ZOZ
  • Zabrze, Poland
    • Samodzielny Publiczny Szpital Kliniczny nr.1
• United States
  • Alabama
    • Homewood, Alabama, United States
      • Urology Centers of Alabama, PC
    • Mobile, Alabama, United States
      • Coastal Clinical Research Inc
  • California
    • Newport Beach, California, United States
      • California Professional Research
  • Colorado
    • Denver, Colorado, United States
      • Genitourinary Surgical Consultants
    • Englewood, Colorado, United States
      • Urology Associates , PC
  • Florida
    • Aventura, Florida, United States
      • South Florida Medical Research
    • Orlando, Florida, United States
      • Winter Park Urology Associates
    • St Petersburg, Florida, United States
      • Pinellas Urology Inc
    • Tampa, Florida, United States
      • Florida Urology Partners
  • Illinois
    • Chicago, Illinois, United States
      • Northwestern University
  • New York
    • New York, New York, United States
      • Weill Cornell Medical College New York Presbyterian
    • Poughkeepsie, New York, United States
      • Hudson Valley Urology, PC
  • North Carolina
    • Durham, North Carolina, United States
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States
      • Patient Priority Clinical Sites, LLC
  • South Carolina
    • Myrtle Beach, South Carolina, United States
      • Carolina Urologic Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Signed informed consent obtained before any trial-related activity is performed
• Men, aged 50 or older
• Clinical signs and symptoms of BPH for ≥6 months
• Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) ≥13
• An IPSS QoL score of ≥3 at screening
• Prostate specific antigen (PSA) at screening ≤10 ng/mL (responsibility of the Investigator to rule out prostate cancer when PSA is >4 ng/mL, except in the USA where patients with a PSA >4 and ≤10 ng/mL should undergo a prostatic biopsy or have a negative prostatic biopsy within 12 months prior to participation in the trial)
• Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume >125 mL at screening

Exclusion Criteria:

• Post void residual volume (PVR) >250 mL
• Stone in the bladder or urethra causing symptoms
• Acute or chronic prostatitis
• Interstitial cystitis / painful bladder syndrome
• Acute or recurrent urinary tract infections
• History of acute urinary retention (AUR)
• Lower urinary tract instrumentation (including prostate biopsy) within 30 days of dosing at Visit 2

• Clinical evidence of any of the following urinary tract conditions:

  1. Mullerian duct cysts
  2. Atonic, decompensated, or hypocontractile bladder
  3. Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation)

• History of any of the following pelvic conditions:

  1. Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery
  2. Pelvic radiotherapy
  3. Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies
  4. Lower tract malignancy or trauma
• Clinically significant microscopic haematuria at screening
• History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 mL/minute at screening
• Systolic blood pressure >180 or <90 mmHg or diastolic blood pressure >110 or <50 mmHg at screening or malignant hypertension
• Any causes other than BPH, which may affect evaluation of symptoms of urine flow (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, and bladder malignancy) as judged by the Investigator
• Use of any prohibited therapies

• Elevated liver function tests at screening:

  1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) >2 times the upper limit of normal
  2. Total bilirubin >1.5 times the upper limit of normal
• QTc interval on the screening ECG >450 ms, or a family history of long QT syndrome
• Any clinically significant disorder (other than BPH) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator
• Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin
• History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
• Mental incapacity or language barrier precluding adequate understanding or co-operation
• History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening
• Hypersensitivity towards any component of the investigational medicinal product (IMP)
• Previous participation in any degarelix trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Mannitol 50 mg/mL solution
Experimental: Degarelix 10 mg	Drug: Degarelix 10 mg; 10 mg degarelix, 40 mg/mL solution; Other Names: Firmagon; FE200486
Experimental: Degarelix 20 mg	Drug: Degarelix 20 mg; 20 mg degarelix, 40 mg/mL solution; Other Names: Firmagon; FE200486
Experimental: Degarelix 30 mg	Drug: Degarelix 30 mg; 30 mg degarelix, 40 mg/mL solution; Other Names: Firmagon; FE200486

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in International Prostate Symptom Score (IPSS)	This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days. The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where "0" corresponds to a response of "not at all" for the first six symptoms and "none" for nocturia, and "5" corresponds to a response of "almost always" for the first six symptoms and "5 times or more" for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score.	From Baseline to Month 3 after Dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in IPSS	This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.	From Baseline to Month 4, Month 5 and Month 6 after Dosing
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS	A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.	At Month 3, Month 4, Month 5 and Month 6 after Dosing
Mean Percentage Change in Total Prostate Volume (TPV)	TPV was measured directly by standardised trans-rectal ultrasound (TRUS).	From Baseline to Month 3 and Month 6 after Dosing
Mean Change in Maximum Urinary Flow (Qmax)	Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).	From Baseline to Month 3 and Month 6 after Dosing

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 27, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Estimate): June 8, 2015
• Last Update Submitted That Met QC Criteria: May 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: FE200486 CS36; 2009-012325-11 (EudraCT Number); 104367 (Other Identifier: IND Number)