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Evaluate Recovery of Testosterone for Patients Using Eligard (Eligard)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136226
Recruitment Status : Completed
First Posted : June 3, 2010
Results First Posted : July 16, 2013
Last Update Posted : October 24, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Eligard (TM) Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Eligard (TM)
Eligard (TM) administered 22.5mg
Drug: Eligard (TM)
Eligard (TM) 22.5 mg administered at baseline and Month 3

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Responsible Party: Chesapeake Urology Research Associates Identifier: NCT01136226    
Other Study ID Numbers: CURA-RT-001
First Posted: June 3, 2010    Key Record Dates
Results First Posted: July 16, 2013
Last Update Posted: October 24, 2018
Last Verified: September 2018
Keywords provided by Chesapeake Urology Research Associates:
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents