Evaluate Recovery of Testosterone for Patients Using Eligard

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chesapeake Urology Research Associates
• Collaborator: Sanofi-Synthelabo
• Treatments: Leuprolide; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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