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Evaluate Recovery of Testosterone for Patients Using Eligard
Evaluate Recovery of Testosterone for Patients Using Eligard
CompletedPhase 4
Sponsor: Chesapeake Urology Research Associates
Conditions: Prostate Cancer
Interventions: Eligard (TM)
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
Eligibility overview
Sex: MALE
Age: 50 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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