Symptomatic Study Investigating Degarelix in Patients Suffering From Prostate Cancer
This study has been terminated.
(Poor recruitment due to rare targeted population)
Sponsor:
Ferring Pharmaceuticals
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00831233
First received: January 27, 2009
Last updated: July 28, 2011
Last verified: July 2011
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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 3 |
| 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:
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
|
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 October 18, 2012
