A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

Study Overview
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Brief Summary
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Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Official Title
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An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Degarelix 80 mg / Degarelix 80 mg
* Drug: Degarelix 160 mg / Degarelix 160 mg
* Drug: Leuprolide 7.5 mg / Degarelix 80 mg
* Drug: Leuprolide 7.5 mg / Degarelix 160 mg


Participation Criteria
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Eligibility Criteria
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Inclusion/Exclusion Criteria: Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. Signed informed consent The patients must have completed the FE 200486 CS21 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 80 mg / Degarelix 80 mg<br>The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. | Drug: Degarelix 80 mg / Degarelix 80 mg<br> <br> * Other names: Firmagon;|
| Experimental: Degarelix 160 mg / Degarelix 160 mg<br>The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. | Drug: Degarelix 160 mg / Degarelix 160 mg<br> <br> * Other names: Firmagon;|
| Experimental: Leuprolide 7.5 mg / Degarelix 80 mg<br>During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. | Drug: Leuprolide 7.5 mg / Degarelix 80 mg<br> <br> * Other names: Lupron;|
| Experimental: Leuprolide 7.5 mg / Degarelix 160 mg<br>During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. | Drug: Leuprolide 7.5 mg / Degarelix 160 mg<br> <br> * Other names: Lupron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. | Up to 4 years of treatment | 
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal. | Up to 4 years of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With no Prostate-specific Antigen (PSA) Progression | PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI). | Until all participants have received at least 5 years of treatment and at a frequency of every 3 months | 
| Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards | The results below present the percentage of participants of having testosterone <=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone >0.5 ng/mL during the study. | Until all participants have received at least 5 years of treatment and at a frequency of every 6 months | 
| Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56 |  | From time of switch to Day 56 | 
| Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56 |  | From time of switch to Day 56 | 
| Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56 |  | From time of switch to Day 56 | 
| Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56 |  | From time of switch to Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degarelix, prostate cancer