Evaluate Recovery of Testosterone for Patients Using Eligard (Eligard)

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Eligard (TM)

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Eligard (TM); Eligard (TM) administered 22.5mg	Drug: Eligard (TM); Eligard (TM) 22.5 mg administered at baseline and Month 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Testosterone Recovery	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	6 mos

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessments	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	6 months

Collaborators and Investigators

• Sponsor: Chesapeake Urology Research Associates
• Collaborators: Sanofi-Synthelabo

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: CURA-RT-001