A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

Study Overview
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Brief Summary
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The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.

Official Title
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An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles

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: Each patient must meet the following inclusion criteria before entry into the study. Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient). Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention. Male patient aged 18 years or over. Has a baseline testosterone above the lower limit of normal range. Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2. Has a PSA value of greater than or equal to 2ng/mL. Exclusion Criteria: Any patient meeting one or more of the following exclusion criteria will not be entered into the study. Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit. Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function. Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit. Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema. Has hypersensitivity towards any component of the investigational products (degarelix or mannitol). Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit. Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study. Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results. Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator. Has a mental incapacity or language barriers precluding adequate understanding or cooperation. Has received an investigational drug within the last 12 weeks preceding Screening Visit. Has previously participated in any degarelix study

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 60mg<br>Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2-13. | Drug: Degarelix<br>* Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.<br>* Other names: FE200486;|
| Experimental: Degarelix 80mg<br>Initial dose of 200 milligrams (40 milligrams per milliliter) of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams (20 milligrams per milliliter) of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13. | Drug: Degarelix<br>* Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.<br>* Other names: FE200486;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364 | Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364 | Day 28 to Day 364 | 
| Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28 | Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364. | Day 28 - Day 364 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3. | Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing. | Day 3 | 
| Days to 50 Percent and 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 50 percent and 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 2 weeks apart. | Day 0 (post dose) to Day 364 | 
| Median Di-Hydrotestosterone Levels At Various Study Timepoints | Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14 | Baseline, Days 1, 3, 7, 14 | 
| Median Prostate-Specific Antigen Values at Various Study Timepoints | Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364. | Baseline, Days 3, 14, 28, 84, 364 | 
| Median Luteinizing Hormone Levels at Various Study Timeframes | Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14. | Baseline, Days 1, 3, 7, 14 | 
| Median Testosterone Levels at Various Days During the Study | Testosterone levels at baseline and days 1, 3, 7, 14 and 364 | Baseline, Days 1,3,7,14,364 | 
| Number of Participants With Abnormal Alanine Aminotransferase Values | Participants whose alanine aminotransferase values were at levels above the normal range. | Day 1 through day 364 | 
| Number of Participants With Abnormal Aspartate Aminotransferase Values | Participants with aspartate aminotransferase values that were above the normal range. | Day 1 - 364 | 
| Number of Participants With Abnormal Total Bilirubin Values | Participants with abnormal total bilirubin values | Day 1 - 364 | 
| Participants 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 participants in each group with normal baseline values and markedly abnormal end-of-study values. | Day 364 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Androgen ablation therapy