Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
NCT ID: NCT00841113
Last Updated: 2009-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
177 participants
INTERVENTIONAL
1999-01-31
2003-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
NCT00521781
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
NCT04446117
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent
NCT02485691
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
NCT03748641
Efficacy of Rotations Between Abiraterone Acetate and Apalutamide in mCRPC Patients
NCT03173859
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1 Abarelix
Investigative drug
Abarelix
100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
2 Goserelin plus bicalutamide
Standard therapy
Goserelin plus Bicalutamide
Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Evidance of advanced disease or metastases
* Life expentancy of at least 3 months
* Normal serum testosterone levels
* Written informed consent
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Speciality European Pharma Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
SEP
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frans M J Debruyne, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Nijmegen
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABACAS1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.