Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Study Overview
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Brief Summary
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Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued. Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

Detailed Description
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The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.

Official Title
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An Open-Label, Multi-Center, Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix
* 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 before 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. Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days. Exclusion Criteria: Any patient meeting any of the following exclusion criteria will not be entered into the study: Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures. Requires hormonal therapy for neoadjuvant purposes. Requires treatment with any other drug modifying the testosterone level or function. Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1. Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions. Has hypersensitivity towards any component of the investigational product. Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin. Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder 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. Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits). Has a mental incapacity or language barrier precluding adequate understanding or co-operation.

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 40 mg<br>Degarelix 40 mg (10 mg/mL) | Drug: Degarelix<br>* One dose (2 x 2 mL) of degarelix 40 mg (10 mg/mL), subcutaneous injection.<br>* Other names: FE200486;|
| Experimental: Degarelix 80 mg<br>Degarelix 80 mg (20 mg/mL) | Drug: Degarelix<br>* One dose (2 x 2 mL) of degarelix 80 mg (20 mg/mL), subcutaneous injection.<br>* Other names: FE200486;|
| Experimental: Degarelix 120 mg<br>Degarelix 120 mg (30 mg/mL) | Drug: Degarelix<br>* One dose (2 x 2 mL) of degarelix 120 mg (30 mg/mL), subcutaneous injection.<br>* Other names: FE200486;|
| Experimental: Degarelix 160 mg<br>Degarelix 160 mg (40 mg/mL) | Drug: Degarelix<br>* One dose (2 x 2 mL) of degarelix 160 mg (40 mg/mL), subcutaneous injection.<br>* Other names: FE200486;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Function Tests | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN. | 3 years | 
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline. | 3 years | 

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