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.
18 Years
N/A
Male
Prostate Cancer
Trial Information
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.
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Early castration rates
Outcome Time Frame:
One week
Safety Issue:
Yes
Principal Investigator
Frans M J Debruyne, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital Nijmegen
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ABACAS1
NCT ID:
NCT00841113
Start Date:
January 1999
Completion Date:
February 2003
Related Keywords:
- Prostate Cancer
- Prostate cancer
- Advanced
- Metastatic
- Prostatic Neoplasms
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