Prostate Cancer
Conditions
Keywords
Prostate cancer, Advanced, Metastatic
Brief summary
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.
Detailed 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
Interventions
DRUGAbarelix
100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
DRUGGoserelin plus Bicalutamide
Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
Sponsors
Speciality European Pharma Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early castration rates | One week |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of medical castration | 48 weeks |
Outcome results
None listed