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

Speciality European Pharma

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Abarelix; Drug: Goserelin plus Bicalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841113

ABACAS1

Details and patient eligibility

About

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

Full 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

Enrollment: 177 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

1 Abarelix

Experimental group

Description:

Investigative drug

Treatment:

Drug: Abarelix

2 Goserelin plus bicalutamide

Active Comparator group

Description:

Standard therapy

Treatment:

Drug: Goserelin plus Bicalutamide