The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

Study Overview
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Brief Summary
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The study was a three-arm, active-control, multi-centre, parallel group study.

Official Title
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An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Conditions
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Prostate Cancer

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


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. Baseline testosterone >1.5 ng/mL. Life expectancy of at least 12 months.

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 240/160 mg<br>Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days. | Drug: Degarelix<br>* Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.<br>* Other names: FE200486;|
| Experimental: degarelix 240/80 mg<br>Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days. | Drug: Degarelix<br>* Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.<br>* Other names: FE 200486;|
| Active Comparator: Leuprolide 7.5 mg<br>Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0. | Drug: Leuprolide 7.5 mg<br>* Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.<br>* Other names: Lupron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 | Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment | A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by >=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14). | 2 weeks | 
| Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 | This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication. | 3 days | 
| Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252 | Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of <=-0.25, >-0.25-0, >0-0.25, >0.25-0.5 and >0.5 ng/mL from mean testosterone levels on Day 252. | Day 252, Day 255, and Day 259 | 
| Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 | Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression. | Days 14 and 28 | 
| Participants Grouped by Time to Prostate-specific Antigen Failure | The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. | 12 months | 
| Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) | Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported. | Baseline to Day 364 | 
| The Mean Value of QTc Interval as Measured by Electrocardiogram | The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias. | 12 months | 
| Participants With Markedly Abnormal Change in Vital Signs and Body Weight | Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer