Evaluate Recovery of Testosterone for Patients Using Eligard

NCT ID: NCT01136226

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-06-30

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eligard (TM)

Eligard (TM) administered 22.5mg

Group Type: OTHER

Eligard (TM)

Intervention Type: DRUG

Eligard (TM) 22.5 mg administered at baseline and Month 3

Interventions

Eligard (TM)

Eligard (TM) 22.5 mg administered at baseline and Month 3

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

Chesapeake Urology Research Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CURA-RT-001

Identifier Type: -

Identifier Source: org_study_id