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A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Elligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer


Phase 4
50 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Elligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer


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 inthe 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

- Venious thrombosis with in 6 Months of Screening

- Uncontrolled Hypertension defined as >170/100 or Symptomatic Hypotension within 3
months of Baseline

- Inuslin dependant Diabetic Patients Must not administer in an anatomic region where
they will recieve 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To Evaluate the time to testosterone recovery after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer

Outcome Description:

To Evaluate the time to testosterone recovery after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer

Outcome Time Frame:

6 mos

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CURA-RT-001

NCT ID:

NCT01136226

Start Date:

October 2003

Completion Date:

June 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms

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