Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00833248
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 246
- 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.
- Previous treatment for prostate cancer
- Previous trans-urethral resection of the prostate
- Patients who are lymph node positive or have other metastatic disease
- Use of urethral catheter
- Current treatment with a 5-alpha reductase inhibitor or α-adrenoceptor antagonist.
- 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.
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Degarelix 240 mg/80 mg 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. Goserelin (3.6 mg) + bicalutamide (50 mg) Goserelin On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. Goserelin (3.6 mg) + bicalutamide (50 mg) Bicalutamide On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
- Primary Outcome Measures
Name Time Method Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) After treatment of 12 weeks compared to Baseline TRUS is a method of measuring the size of the prostate.
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) After treatment of 12 weeks compared to Baseline TRUS is a method of measuring the size of the prostate.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 After treatment of 4, 8, and 12 weeks compared to Baseline 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 Serum Testosterone Levels During the Study After treatment of 4, 8, and 12 weeks compared to Baseline Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study After treatment of 4, 8, and 12 weeks compared to Baseline Change From Baseline in Serum Oestradiol Levels During the Study After treatment of 4, 8, and 12 weeks compared to Baseline Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit After treatment of 4, 8, and 12 weeks compared to Baseline 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').
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight Baseline to 12 weeks of treatment 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 Baseline to 12 weeks of treatment 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 one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Trial Locations
- Locations (66)
Kent Oncology Centre Maidstone Hospital
🇬🇧Maidstone, Kent, United Kingdom
Clinique du Parc
🇫🇷Toulouse, France
Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau
🇫🇷Saint Herblain Cedex, France
Centre Paul Strauss
🇫🇷Strassbourg, France
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Alaska Urological Association
🇺🇸Anchorage, Alaska, United States
Arizona Urologic Specialists
🇺🇸Tuscon, Arizona, United States
Orange County Urology
🇺🇸Lagua Hills, California, United States
Tri-Valley Urology Medical Group
🇺🇸Murrieta, California, United States
Urology Group of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Hopital Jean Minjoz
🇫🇷Besancon, France
Centre de radiologie Saint Louis
🇫🇷Toulon, France
Urology of Virginia
🇺🇸Norfolk, Virginia, United States
Centre Francois Baclesse
🇫🇷Caen, France
DCT -Celebration, LLC dba Discovery Clinical Trials
🇺🇸Celebration, Florida, United States
Summit Research Institute
🇺🇸Bloomington, Indiana, United States
Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie
🇩🇪Berlin, Germany
Städtisches Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Hôpital Tenon
🇫🇷Paris, France
Centre Leon Berard
🇫🇷Lyon, France
Institut Bergonié
🇫🇷Bordeaux Cedex, France
CHU Henri Mondor
🇫🇷Creteil, France
Premier Medical Group of Hudson
🇺🇸Columbia, New York, United States
CRLC Val d'Aurelle Oncology Radiotherapy
🇫🇷Montpellier, France
General University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
General Hospital of Athens, "Sismanogleio", University of Athens, Marouse
🇬🇷Athens, Greece
St. Elisabeth Ziekenhuis Tilburg
🇳🇱Tilburg, Netherlands
St. James' University Hospital
🇬🇧Leeds, United Kingdom
Clinique Saint Brieuc
🇫🇷St Brieuc Cedex, France
The Royal Marsden NHS, Foundation Trust
🇬🇧London, United Kingdom
Clinique Francheville
🇫🇷Perigueux, France
Institut de Cancérologie de la Loire
🇫🇷Saint Priest en Jarez, France
Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie
🇩🇪Dresden, Germany
University General Hospital of Patras
🇬🇷Patras, Greece
Fundación IVO
🇪🇸Valencia, Spain
Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie
🇩🇪Ulm, Germany
CHU La Milétrie, Oncology Radiotherapy
🇫🇷Poitiers, France
University General Hospital of Loannina, Medical School
🇬🇷Loannina, Greece
Vlietland Ziekenhuis, Dept. urology
🇳🇱Schiedam, Netherlands
Velindre Hospital, Cardiff University
🇬🇧Whitchurch, United Kingdom
Albert Schweitzer Ziekenhuis, Ioc., Dordwijk
🇳🇱Dordrecht, Netherlands
Groene Hart Ziekenhuis, urology
🇳🇱Gouda, Netherlands
Franciscus Gasthuis, Dept. urology
🇳🇱Rotterdam, Netherlands
Maastad Ziekenhuis, Ioc. Clara
🇳🇱Rotterdam, Netherlands
Hospital Universitari Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Mount Vernon Cancer Center
🇬🇧Northwood, Middlesex, United Kingdom
IGR
🇫🇷Villejuif, France
Urology Center Research Institute
🇺🇸Englewood, New Jersey, United States
Alabama Research Center
🇺🇸Birmingham, Alabama, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Pinellas Urology Inc.
🇺🇸St. Petersburg, Florida, United States
Palm Beach Urology Associates
🇺🇸Wellington, Florida, United States
Northeast Indiana Research
🇺🇸Fort Wayne, Indiana, United States
University Urology Associates
🇺🇸New York, New York, United States
Centre Oscar Lambret
🇫🇷Lille, France
Hopital de la Timone
🇫🇷Marseille, Cedex 5, France
Hôpital Saint Louis, Radiotherapy Departement
🇫🇷Paris, France
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Oncology Royal United Hospital Bath NHS Trust
🇬🇧Bath, United Kingdom
Addenbrooke's Hospital, Oncology Centre
🇬🇧Cambridge, United Kingdom
Northern Centre for Cancer Treatment, Newcastle General Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre
🇬🇧Southhampton, United Kingdom
Urology Associates
🇺🇸Nashville, Tennessee, United States
Connecticut Clinical Research Center
🇺🇸Middlebury, Connecticut, United States
Charing Cross Hospital
🇬🇧London, United Kingdom