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

This study has been completed.
Sponsor:
Information provided by:
Speciality European Pharma Limited
ClinicalTrials.gov Identifier:
NCT00841113
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 10, 2009
February 10, 2009
January 1999
February 2001   (final data collection date for primary outcome measure)
Early castration rates [ Time Frame: One week ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Maintenance of medical castration [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
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.

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

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Abarelix
    100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
    Other Name: Plenaxis
  • Drug: Goserelin plus Bicalutamide
    Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
  • Experimental: 1 Abarelix
    Investigative drug
    Intervention: Drug: Abarelix
  • Active Comparator: 2 Goserelin plus bicalutamide
    Standard therapy
    Intervention: Drug: Goserelin plus Bicalutamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
February 2003
February 2001   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00841113
ABACAS1
No
Speciality European Pharma Limited, SEP
Speciality European Pharma Limited
Not Provided
Principal Investigator: Frans M J Debruyne, MD University Hospital Nijmegen
Speciality European Pharma Limited
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP