- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841113
Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
February 10, 2009 updated by: Speciality European Pharma Limited
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.
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
177
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1 Abarelix
Investigative drug
|
100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
Other Names:
|
ACTIVE_COMPARATOR: 2 Goserelin plus bicalutamide
Standard therapy
|
Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Early castration rates
Time Frame: One week
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maintenance of medical castration
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frans M J Debruyne, MD, University Hospital Nijmegen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Primary Completion (ACTUAL)
February 1, 2001
Study Completion (ACTUAL)
February 1, 2003
Study Registration Dates
First Submitted
February 10, 2009
First Submitted That Met QC Criteria
February 10, 2009
First Posted (ESTIMATE)
February 11, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 11, 2009
Last Update Submitted That Met QC Criteria
February 10, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Androgen Antagonists
- Goserelin
- Bicalutamide
- Abarelix
Other Study ID Numbers
- ABACAS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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