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

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 (FDA regulated intervention is therefore ticked YES). The data include participants from both the main study (FE200486 CS07; NCT00818623) and the extension study FE200486 CS07A.

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
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix
* Drug: Degarelix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged 18 or over Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy) Has completed Study FE200486 CS07 Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07

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 120 mg (20 mg/mL)<br>Degarelix 120 mg (20 mg/mL) | Drug: Degarelix<br>* Degarelix 120 mg (20 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<br>* Other names: FE200486;|
| Experimental: Degarelix 120 mg (40 mg/mL)<br>Degarelix 120 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix 120 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<br>* Other names: FE200486;|
| Experimental: Degarelix 160 mg (40 mg/mL)<br>Degarelix 160 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix 160 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<br>* Other names: FE200486;|
| Experimental: Degarelix 200 mg (40 mg/mL)<br>Degarelix 200 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix 200 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<br>* Other names: FE200486;|
| Experimental: Degarelix 200 mg (60 mg/mL)<br>Degarelix 200 mg (60 mg/mL) | Drug: Degarelix<br>* Degarelix 200 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<br>* Other names: FE200486;|
| Experimental: Degarelix 240 mg (40 mg/mL)<br>Degarelix 240 mg (40 mg/mL) | Drug: Degarelix<br>* Degarelix 240 mg (40 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<br>* Other names: FE200486;|
| Experimental: Degarelix 240 mg (60 mg/mL)<br>Degarelix 240 mg (60 mg/mL) | Drug: Degarelix<br>* Degarelix 240 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<br>* Other names: FE200486;|
| Experimental: Degarelix 320 mg (60 mg/mL)<br>Degarelix 320 mg (60 mg/mL) | Drug: Degarelix<br>* Degarelix 320 mg (60 mg/mL). Participants received same dose as in main study (FE200486 CS07; NCT00818623). Administration intervals were individualised for each participant (based on the duration of testosterone suppression in study FE200486 CS07).<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 patients in each group with normal baseline and markedly abnormal value post-baseline. | 3 years |