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

Prostate Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841113
• Other study ID #: ABACAS1
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2009
• Last updated: February 10, 2009
• Start date: January 1999
• Est. completion date: February 2003

Study information

• Verified date: February 2009
• Source: Speciality European Pharma Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: February 2003
• Est. primary completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Abarelix
100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
• Goserelin plus Bicalutamide
Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Speciality European Pharma Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early castration rates		One week	Yes
Secondary	Maintenance of medical castration		48 weeks	No