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Evaluate Recovery of Testosterone for Patients Using Eligard
Evaluate Recovery of Testosterone for Patients Using Eligard

NCT01136226

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