Evaluate Recovery of Testosterone for Patients Using Eligard

This study has been completed.
Sponsor:
Collaborator:
Sanofi-Synthelabo
Information provided by (Responsible Party):
Chesapeake Urology Research Associates
ClinicalTrials.gov Identifier:
NCT01136226
First received: June 2, 2010
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Eligard (TM)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chesapeake Urology Research Associates:

Primary Outcome Measures:
  • Serum Testosterone Recovery [ Time Frame: 6 mos ] [ Designated as safety issue: Yes ]
    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:
  • Safety Assessments [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 42
Study Start Date: October 2003
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm- Eligard
Eligard 22.5mg is only intervention administered
Drug: Eligard (TM)
22.5 mg administered at baseline and Month 3

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Chesapeake Urology Research Associates
ClinicalTrials.gov Identifier: NCT01136226     History of Changes
Other Study ID Numbers: CURA-RT-001
Study First Received: June 2, 2010
Results First Received: April 12, 2013
Last Updated: July 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Chesapeake Urology Research Associates:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Leuprolide
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 21, 2014