Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer - Full Text View

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00831233

Purpose

The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.

Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix Drug: Goserelin Drug: Bicalutamide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomised, Parallel-arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Reduction in International Prostate Symptom Score (IPSS), in Patients With Lower Urinary Tract Symptoms (LUTS) Secondary to Locally Advanced Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Urine and Urination

Drug Information available for: Goserelin Bicalutamide Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: After treatment of 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

Secondary Outcome Measures:

Change From Baseline in Total IPSS at Weeks 4 and 8 [ Time Frame: After treatment of 4 and 8 weeks compared to Baseline ] [ Designated as safety issue: No ]
The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Change From Baseline in Maximum Urine Flow (Qmax) at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Uroflowmetry was used to quantify the maximum urine flow (Qmax; mL/sec)
Change From Baseline in Residual Volume (Vresidual) at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Uroflowmetry was used to quantify the residual volume (Vresidual; mL)
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 [ Time Frame: After 12 weeks treatment compared to Baseline ] [ Designated as safety issue: No ]
TRUS is a method of measuring the size of the prostate.
Number of Participants With Testosterone <=0.5 Nanograms/Milliliter at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Percentage Change From Baseline in Prostate-specific Antigen (PSA) Concentration at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit [ Time Frame: After treatment of 4, 8 and 12 weeks compared to Baseline ] [ Designated as safety issue: No ]
The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). The figures in the tables present the change (ie decrease) in IPSS QoL score, i.e. the bigger the decrease the better QoL.
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [ Time Frame: Baseline to 12 weeks of treatment ] [ Designated as safety issue: No ]
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables [ Time Frame: Baseline to 12 weeks of treatment ] [ Designated as safety issue: No ]
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least on participant with one abnormal value are presented, many more variables were included in the trial.

Enrollment:	42
Study Start Date:	April 2009
Study Completion Date:	July 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Degarelix 240 mg/80 mg Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)	Drug: Degarelix The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. Other Name: FE200486
Active Comparator: Goserelin (3.6 mg) + bicalutamide (50 mg) Goserelin (3.6 mg) + bicalutamide (50 mg)	Drug: Goserelin Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively. Other Name: Zoladex Drug: Bicalutamide On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin. Other Name: Casodex

Arms

Assigned Interventions

Experimental: Degarelix 240 mg/80 mg

Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)

Drug: Degarelix

The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.

Other Name: FE200486

Active Comparator: Goserelin (3.6 mg) + bicalutamide (50 mg)

Goserelin (3.6 mg) + bicalutamide (50 mg)

Drug: Goserelin

Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively.

Other Name: Zoladex

Drug: Bicalutamide

On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.

Other Name: Casodex

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has given written informed consent before any trial-related activity is performed
Has a confirmed prostate cancer in which this type of treatment is needed.

Exclusion Criteria:

Previous treatment for prostate cancer
Previous trans-urethral resection of the prostate
Current use of 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
Patients in need of external beam radiotherapy to be started at the same time as hormone therapy
Certain risk factors for abnormal heart rhythms/QT prolongation (corrected QT interval over 450 msec., Torsades de Pointes or use of certain medications with potential risk)
History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Hypersensitivity towards any component of the investigational product
Other previous cancers within the last five years with the exception of prostate cancer and some types of skin cancer.
Clinical disorders other than prostate cancer including but not limited to renal, haematological, gastrointestinal, endocrine, cardiac, neurological, psychiatric disease, alcohol or drug abuse or other conditionals as judged by the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831233

Locations

Germany
Facharztpraxis für Urologie
Bamberg, Germany, 96047
Gemeinschaftspraxis
Borken, Germany, 46325
Universitätsklinikum Dresden
Dresden, Germany, 01307
Euromed Clinic
Fürth, Germany, 90763
Urologische Gemeinschaftspraxis
Hamburg, Germany, 22399
Gemeinschaftspraxis
Köln, Germany, 50667
VITURO Gesellschaft für Klinische Studien
Leipzig, Germany, 04109
Klinikum Offenbach GmbH
Offenbach, Germany, 63069
Urologische Klinik Planegg
Planegg, Germany, 82152
Wuppertaler Gemeinschaftspraxis
Wuppertal, Germany, 42103
Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares-Madrid, Spain, 28805
Fundacion Hospital Alcorcón
Alcorcon, Spain, 28922
Fundación Puigvert
Barcelona, Spain, 08025
Hospital de Basurto
Bilbao (Bizkaia), Spain, 48013
Complejo Hospitalario Universitario A Coruña
Coruña, Spain
Hospital universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Clinico Universitario S. Carlos
Madrid, Spain, 28040
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Manacor
Manacor, Spain, 07500
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
Hospital Santiago de Compostela
Santiago de Compostela, Spain, 15706
Hospital Virgen Macarena
Sevilla, Spain, 41014
Hospital Xeral de Vigo
Vigo, Spain, 36204
United Kingdom
United Bristol Healthcare NHSTrust Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Falkirk and District Royal Infirmary
Falkirk, United Kingdom, FK1 5QE
Southern General Hospital
Glasgow, United Kingdom, G51 4TF
Castle Hill Hospital
Hull, United Kingdom, HU16 5JQ
King's College Hospital
London, United Kingdom, SE5 9RS
Whipps Cross University Hospital
London, United Kingdom, E11 1NR
The Royal Free Hospital
London, United Kingdom, NW3 2QG
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Royal Hallamshire Hospital, Sheffield South
Sheffield, United Kingdom, S10 2JF
Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 7TP

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00831233 History of Changes
Other Study ID Numbers:	FE200486 CS28, 2008-004338-26
Study First Received:	January 27, 2009
Results First Received:	June 14, 2011
Last Updated:	July 28, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Bicalutamide

Goserelin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012