Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: degarelix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix 200/80<br>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. | Drug: degarelix<br>* Degarelix was given as subcutaneous injections.<br>* Other names: FE200486;|
| Experimental: Degarelix 200/120<br>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. | Drug: degarelix<br>* Degarelix was given as subcutaneous injections.<br>* Other names: FE200486;|
| Experimental: Degarelix 200/160<br>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. | Drug: degarelix<br>* Degarelix was given as subcutaneous injections.<br>* Other names: FE200486;|
| Experimental: Degarelix 240/80<br>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. | Drug: degarelix<br>* Degarelix was given as subcutaneous injections.<br>* Other names: FE200486;|
| Experimental: Degarelix 240/120<br>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. | Drug: degarelix<br>* Degarelix was given as subcutaneous injections.<br>* Other names: FE200486;|
| Experimental: Degarelix 240/160<br>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. | Drug: degarelix<br>* Degarelix was given as subcutaneous injections.<br>* Other names: FE200486;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | Number of patients who achieved a testosterone level considered a castration level. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Day 28 - 364 | 
| Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle. | Day 28 | 
| Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days. | Day 3 | 
| Days to 50 Percent Reduction in Prostate-Specific Antigen | Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value. | Day 0 (post dose) to Day 364 | 
| Days to 90 Percent Reduction in Prostate-Specific Antigen | Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value. | Day 0 (post dose) to Day 364 | 
| Days to Prostate-Specific Antigen Progression | 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. | Day 0 (post dose) to Day 364 | 
| 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 | 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. | 364 days | 
| The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | 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. | Day 364 |