A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD

Study Overview
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Brief Summary
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Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.

Official Title
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A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: leuprorelin acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At study entry (visit 1): Written informed consent Male subjects aged >=18 and <80 years old Locally advanced (stage T3 or T4) prostate cancer or Relapsing prostate cancer following radical prostatectomy or,Relapsing prostate cancer following radiotherapy Gleason score of >=6 ECOG performance status of 0-2. Life expectancy at least 5 years At randomization (visit 4): Two successive decreasing serum PSA levels <=1 ng/ml Exclusion Criteria: At study entry (visit 1): Any suspected second primary tumors Evidence of metastatic disease Other malignancy within the last 5 years except Acute spinal cord compression, uni- or bilateral ureteric obstruction Any concurrent biological response modifier therapy Concurrent chemotherapy Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy Less than 6 months since prior 5-alpha reductase inhibitor treatment Other concurrent hormonal therapy Any concurrent radiotherapy Testosterone at screening <= 1.7 mM or 50 ng/dL Clinically significant elevation of serum creatinine or liver enzymes Hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate Hypersensitivity to CASODEXâ 50 mg.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Continuous Androgen Deprivation (CAD)<br> | Drug: leuprorelin acetate<br>* LHRH antagonist<br>* Other names: ELIGARD 22.5 mg;|
| Experimental: Intermittent Androgen Deprivation (IAD)<br> | Drug: leuprorelin acetate<br>* LHRH antagonist<br>* Other names: ELIGARD 22.5 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to PSA progression |  | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 Years | 
| World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status |  | 3 Years | 
| European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25 |  | 3 Years | 
| Time to serum testosterone > 50 ng/dL |  | 3 Years | 
| Change in progression biomarkers (some sites) |  | 3 Years | 

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