Evaluate Recovery of Testosterone for Patients Using Eligard

Chesapeake Urology Research Associates

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Eligard (TM)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01136226

CURA-RT-001

Details and patient eligibility

About

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

Full 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).

Enrollment

42 patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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