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A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy


Phase 3
18 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy


Inclusion Criteria:



At study entry (visit 1):

- Written informed consent

- Male subjects aged >=18 and <80 years old

- Locally advanced (stage T3 or T4) prostate cancer or Relapsing prostate cancer
following radical prostatectomy or,Relapsing prostate cancer following radiotherapy

- Gleason score of >=6

- ECOG performance status of 0-2.

- Life expectancy at least 5 years

At randomization (visit 4):

- Two successive decreasing serum PSA levels <=1 ng/ml

Exclusion Criteria:

At study entry (visit 1):

- Any suspected second primary tumors

- Evidence of metastatic disease

- Other malignancy within the last 5 years except

- Acute spinal cord compression, uni- or bilateral ureteric obstruction

- Any concurrent biological response modifier therapy

- Concurrent chemotherapy

- Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy

- Less than 6 months since prior 5-alpha reductase inhibitor treatment

- Other concurrent hormonal therapy

- Any concurrent radiotherapy

- Testosterone at screening <= 1.7 mM or 50 ng/dL

- Clinically significant elevation of serum creatinine or liver enzymes

- Hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate

- Hypersensitivity to CASODEXâ 50 mg.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to PSA progression

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Central Contact

Investigator Role:

Study Director

Investigator Affiliation:

Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive

Authority:

Austria: Ethikkommission

Study ID:

EGD-EC-003

NCT ID:

NCT00378690

Start Date:

March 2006

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostate Specific Antigen
  • Prostatic Neoplasms

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