Status:
COMPLETED
A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief Summary
Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
706 Patients enrolled
Trial Details
Trial ID
NCT00378690
Start Date
March 1 2006
End Date
December 1 2012
Last Update
June 4 2014
Active Locations (71)
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1
Brussels, Belgium, 1070
2
Brussels, Belgium, 1200
3
Brussels, Belgium
4
Leuven, Belgium, B-3000