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.