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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Abarelix
Goserelin plus Bicalutamide
Sponsored by
Speciality European Pharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Advanced, Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1 Abarelix

    2 Goserelin plus bicalutamide

    Arm Description

    Investigative drug

    Standard therapy

    Outcomes

    Primary Outcome Measures

    Early castration rates

    Secondary Outcome Measures

    Maintenance of medical castration

    Full Information

    First Posted
    February 10, 2009
    Last Updated
    February 10, 2009
    Sponsor
    Speciality European Pharma Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00841113
    Brief Title
    Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1999 (undefined)
    Primary Completion Date
    February 2001 (Actual)
    Study Completion Date
    February 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Speciality European Pharma Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Prostate cancer, Advanced, Metastatic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    177 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 Abarelix
    Arm Type
    Experimental
    Arm Description
    Investigative drug
    Arm Title
    2 Goserelin plus bicalutamide
    Arm Type
    Active Comparator
    Arm Description
    Standard therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Abarelix
    Other Intervention Name(s)
    Plenaxis
    Intervention Description
    100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
    Intervention Type
    Drug
    Intervention Name(s)
    Goserelin plus Bicalutamide
    Intervention Description
    Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months
    Primary Outcome Measure Information:
    Title
    Early castration rates
    Time Frame
    One week
    Secondary Outcome Measure Information:
    Title
    Maintenance of medical castration
    Time Frame
    48 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frans M J Debruyne, MD
    Organizational Affiliation
    University Hospital Nijmegen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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