Evaluate Recovery of Testosterone for Patients Using Eligard

Study Overview
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Brief Summary
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The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.

Detailed Description
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This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).

Official Title
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A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Eligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Eligard (TM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be outpatient, not hospitalized Male Patient between ages 50-80, inclusive Histologically/Cytologically graded adenocarcinoma of the prostate Must have T1, T2 or T3a adenocarcinoma of the prostate Must be a candidate for radiation therapy. Hormone refractory patients excluded WHO/ECOG score of 0,1 or 2 Exclusion Criteria: NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator. Used the following treatments for prostate Cancer *immunotherapy *chemotherapy *External Beam Radiation *brachytherapy *hormonal therapy *biological response modifiers Prior Prostate Surgery (excluding TUNA or TURP) Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect uncontrolled CHF within 6 months to baseline Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit Venous thrombosis with in 6 Months of Screening Uncontrolled Hypertension defined as >170/100 or Symptomatic Hypotension within 3 months of Baseline Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard. Drug or Alcohol Abuse 6 months prior to Baseline Other Serious Illness at the discretion of the Investigator Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline Hypersensitivity to GnRH, GnRH agonists

Ages Eligible for Study
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Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eligard (TM)<br>Eligard (TM) administered 22.5mg | Drug: Eligard (TM)<br>* Eligard (TM) 22.5 mg administered at baseline and Month 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Testosterone Recovery | To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer | 6 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessments | Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire | 6 months | 

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