Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
Age
18–80
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
