Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
Phase 3
Completed
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00841113
- Lead Sponsor
- Speciality European Pharma Limited
- 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 surge in the first month of treatment.
* Maintenance of medical castration during one year of therapy.
* Comparison of the treatments on QTc prolongation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 177
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Abarelix Abarelix Investigative drug 2 Goserelin plus bicalutamide Goserelin plus Bicalutamide Standard therapy
- Primary Outcome Measures
Name Time Method Early castration rates One week
- Secondary Outcome Measures
Name Time Method Maintenance of medical castration 48 weeks