Open-Label, Randomised Parallel-Group Study

Study Overview
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Brief Summary
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An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.

Official Title
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The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Degarelix
* Drug: Degarelix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. Screening testosterone level above the lower limit of normal range, globally defined as > 2.2 ng/mL. Screening PSA level of =2 ng/mL. ECOG score of =2. Life expectancy of at least one year. CRITERIA FOR EVALUATION: Primary endpoint: Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364. Secondary endpoints: Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364. Serum levels of testosterone, LH, FSH, and PSA over time. Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir. Plasma levels of degarelix over time. Frequency and severity of adverse events. Clinically significant changes in laboratory safety parameters. Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.

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: 1<br>Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months | Drug: Degarelix<br>* Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.<br>|
| Experimental: 2<br>Starting dose of 240 mg (40 mg/mL) will be given on Day 0. Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months. | Drug: Degarelix<br>* Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients. |  | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. |  | 3-month | 
| To evaluate pharmacokinetic response. |  | 3-month | 
| To compare safety and tolerability profiles of different degarelix three-month dosing regimens. |  | 3-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer requiring Androgen Ablation Therapy