Status:
COMPLETED
Evaluate Recovery of Testosterone for Patients Using Eligard
Lead Sponsor:
Chesapeake Urology Research Associates
Collaborating Sponsors:
Sanofi-Synthelabo
Conditions:
Prostate Cancer
Eligibility:
MALE
50-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01136226
Start Date
October 1 2003
End Date
June 1 2009
Last Update
October 24 2018
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