Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Speciality European Pharma Limited
• Treatments: Abarelix; Bicalutamide; Goserelin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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