Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
- Registration Number
- NCT00819156
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.
- Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 189
- Written informed consent prior to any study related procedures
- Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
- ECOG score to be equal to or above 2
- Testosterone level within age-specific normal range
- PSA value equal to or above 2 ng/ml
- Life expectancy of at least 6 months
- Previous or current hormonal treatment of prostate cancer
- Recent or current treatment with any drugs modifying the testosterone level
- Candidate for curative treatment such as prostatectomy or radiotherapy
- History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
- Hypersensitivity towards any component of degarelix or mannitol
- Cancer disease within the last 5 years except for prostate cancer and some skin cancers
- Signs of liver impairment shown as elevated serum ALT or serum bilirubin
- Known hepatic disease
- Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
- Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
- Mental incapacity or language barrier precluding adequate understanding or cooperation
- Having received an investigational product within the last 12 weeks preceding the trial
- Previous participation in this trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Degarelix 240/160 degarelix Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Degarelix 240/120 degarelix Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Degarelix 200/80 degarelix Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days. Degarelix 200/120 degarelix Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days. Degarelix 200/160 degarelix Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days. Degarelix 240/80 degarelix Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
- Primary Outcome Measures
Name Time Method Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 12 months Number of patients who achieved a testosterone level considered a castration level.
- Secondary Outcome Measures
Name Time Method Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. Day 3 The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after 3 days.
Days to 50 Percent Reduction in Prostate-Specific Antigen Day 0 (post dose) to Day 364 Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28 Day 28 - 364 Number of patients who maintained a castration level of testosterone (\<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. Day 28 The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
Days to 90 Percent Reduction in Prostate-Specific Antigen Day 0 (post dose) to Day 364 Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
Days to Prostate-Specific Antigen Progression Day 0 (post dose) to Day 364 Median days to prostate-specific antigen increase of \>= 50 percent and \>=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
Median Serum Testosterone Levels Day 0 (Baseline), Days 1,3,7,14, and 364 Median Prostate-specific Antigen Levels Day 0 (Baseline), Days 3, 7, 14, and 364 Median Values of Di-Hydrotestosterone Day 0 (Baseline), Days 1, 3, 7, 14, and 364 Median Values for Serum Luteinizing Hormone Day 0 (Baseline), Days 1, 3, 7, 14, and 364 Median Values for Follicle Stimulation Hormone Day 0 (Baseline), Days 1, 3, 7, 14, and 364 The Number of Patients With Abnormal Liver Function Tests 364 days The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases \>3x ULN, and patients with ALT increases \>3x ULN with concurrent increases in bilirubin \>1.5 ULN.
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight Day 364 Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.
Trial Locations
- Locations (38)
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Urologische Universitätsklinikum
🇩🇪Mannheim, Germany
Pez Aladar County Hospital
🇭🇺Györ, Hungary
Vivantes Klinikum am Urban
🇩🇪Berlin, Germany
Pavlov medical School, Urology
🇷🇺St Petersburg, Russian Federation
UCL Saint Luc
🇧🇪Brussels, Belgium
UZ Gent
🇧🇪Gent, Belgium
Loretto Krankenhaus
🇩🇪Freiburg, Germany
Bajcsy-Zsilinszky Hospital, Urology
🇭🇺Budapest, Hungary
Jahn Ferenc Dél Pesti Hospital, Urology
🇭🇺Budapest, Hungary
BAZ County Hospital
🇭🇺Miskolc, Hungary
Hospital of Local Gov. Szeged, Urology
🇭🇺Szeged, Hungary
Wojewódzki Szpital Specjalisttyczny
🇵🇱Slupsk, Poland
MÁV Hospital, Urology
🇭🇺Szolnok, Hungary
AMC
🇳🇱Amsterdam, Netherlands
CF2 Hospital
🇷🇴Bucharest, Romania
Atrium MC
🇳🇱Heerlen, Netherlands
Dr. Th Burghele Hospital
🇷🇴Bucharest, Romania
Botkin Clinical Hospital
🇷🇺Moscow, Russian Federation
City Hospital #1
🇷🇺Moscow, Russian Federation
City Hospital #60
🇷🇺Moscow, Russian Federation
City Hospital #50
🇷🇺Moscow, Russian Federation
City Hospital #29
🇷🇺Moscow, Russian Federation
Institute of Urology of MoH
🇷🇺Moscow, Russian Federation
"Andros" Urology Clinic
🇷🇺St Petersburg, Russian Federation
City Hospital #15
🇷🇺St Petersburg, Russian Federation
Pavlov Medical School Outpatient
🇷🇺St Petersburg, Russian Federation
City Hospital #26
🇷🇺St Petersburg, Russian Federation
Sct Petersburg State Medical Academy
🇷🇺St Petersburg, Russian Federation
370 Clarke Road
🇿🇦Glenwood, Durban, South Africa
Military Medical Academy, Urology
🇷🇺St Petersburg, Russian Federation
Pretoria Urology Hospital
🇿🇦Hatfield, Pretoria, South Africa
WITS Medical School
🇿🇦Parktown, South Africa
Sunninghill Clinic
🇿🇦Sunninghill, South Africa
401B Medical Centre
🇿🇦Pietermaritzburg, South Africa
Euromed AG Klinik
🇩🇪Fürth, Germany
Fundeni Hospital
🇷🇴Bucharest, Romania
Sf. Ioan Hospital
🇷🇴Bucharest, Romania