Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.
- Males over 18 with documented advanced or metastatic prostate cancer
- 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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Early castration rates
Frans M J Debruyne, MD
University Hospital Nijmegen
Germany: Federal Institute for Drugs and Medical Devices