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OpenTrials
Completed

NCT Number: NCT01136226

Evaluate Recovery of Testosterone for Patients Using Eligard

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eligard (TM)

Drug

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

Primary outcomes

  1. Serum Testosterone Recovery

    Time frame: 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 outcomes

  1. Safety Assessments

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chesapeake Urology Research Associates

Other

Collaborators

  • Sanofi-Synthelabo

Registry information

Official study 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

Acronym: Eligard

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2010
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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