Trial | NCT00841113  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    177
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
Study Started
Jan 31
1999
Primary Completion
Feb 28
2001
Study Completion
Feb 28
2003
Last Update
Feb 11
2009
Estimate

Drug Abarelix

100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter

  • Other names: Plenaxis

Drug Goserelin plus Bicalutamide

Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months

1 Abarelix Experimental

Investigative drug

2 Goserelin plus bicalutamide Active Comparator

Standard therapy

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
No Results Posted