Title

Evaluate Recovery of Testosterone for Patients Using 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
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    leuprolide ...
  • Study Participants

    42
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
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 Started
Oct 31
2003
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Results Posted
Jul 16
2013
Estimate
Last Update
Oct 24
2018

Drug Eligard (TM)

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

Eligard (TM) Other

Eligard (TM) administered 22.5mg

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

Summary

Single Arm- Eligard

All Events

Event Type Organ System Event Term

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

Single Arm- Eligard

6.0
Months (Mean)
Full Range: 1.0 to 18.0

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

Eligard (TM)

Age, Continuous

70.8
years (Mean)
Standard Deviation: 6.4

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Single Arm- Eligard