Evaluate Recovery of Testosterone for Patients Using Eligard

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Eligard (TM)

• Registration Number: NCT01136226
• Lead Sponsor: Chesapeake Urology Research Associates

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 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Results First Submitted: 2013-04-12
• Results First Submitted QC: 2013-07-12
• Results First Posted: 2013-07-16
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eligard (TM)	Eligard (TM)	Eligard (TM) administered 22.5mg

Primary Outcome Measures

Name	Time	Method
Serum Testosterone Recovery	6 mos	To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer

Secondary Outcome Measures

Name	Time	Method
Safety Assessments	6 months	Assess frequency and severity of spontaneously reported AE's Changes between baseline and testosterone recovery in serum testosterone and pre biopsy PSA clinical evidence of Prostate cancer changes between baseline and testosterone recovery in health questionnaire