Evaluate Recovery of Testosterone for Patients Using Eligard

Condition(s) targeted: Prostate Cancer

Intervention: Eligard (TM) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Chesapeake Urology Research Associates

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

Official title: 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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Serum Testosterone Recovery

Secondary outcome: Safety Assessments

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Male.

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

Starting date: October 2003
Last updated: July 16, 2013