Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
NCT00841113 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177
Last updated 2009-02-11
Summary
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.
Conditions
Interventions
- DRUG
-
Abarelix
100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
- DRUG
-
Goserelin plus Bicalutamide
Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
Sponsors & Collaborators
-
Speciality European Pharma Limited
lead INDUSTRY
Principal Investigators
-
Frans M J Debruyne, MD · University Hospital Nijmegen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-01-31
- Primary Completion
- 2001-02-28
- Completion
- 2003-02-28
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