Status:
COMPLETED
Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
Lead Sponsor:
Speciality European Pharma Limited
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.
Detailed Description
Inclusion Criteria * Males over 18 with documented advanced or metastatic prostate cancer Outcome measures * Comparative castration rates one week after starting therapy * Degree of testosterone su...
Eligibility Criteria
Inclusion
- Histologically proven prostate cancer and not previously treated with hormones
- Evidance of advanced disease or metastases
- Life expentancy of at least 3 months
- Normal serum testosterone levels
- Written informed consent
Exclusion
- Previous endocrine or cytoxic theapy for prostate cancer
- Known tumour complication of prostate cancer which owuld require immediate treatment
- Another malignancy other than basal cell cancer
- History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists.
- Congenital or acquired coagulation disorders contraindicating intramuscular injections
- Pagets disease of the bone
- QTcB \> 450 msec at Day - 14
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00841113
Start Date
January 1 1999
End Date
February 1 2003
Last Update
February 11 2009
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