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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841113
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : February 11, 2009
Information provided by:
Speciality European Pharma Limited

Brief Summary:
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Abarelix Drug: Goserelin plus Bicalutamide Phase 3

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  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 1999
Actual Primary Completion Date : February 2001
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Abarelix
Investigative drug
Drug: Abarelix
100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter
Other Name: Plenaxis
Active Comparator: 2 Goserelin plus bicalutamide
Standard therapy
Drug: Goserelin plus Bicalutamide
Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months

Primary Outcome Measures :
  1. Early castration rates [ Time Frame: One week ]

Secondary Outcome Measures :
  1. Maintenance of medical castration [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00841113

Sponsors and Collaborators
Speciality European Pharma Limited
Principal Investigator: Frans M J Debruyne, MD University Hospital Nijmegen

Responsible Party: Speciality European Pharma Limited, SEP Identifier: NCT00841113     History of Changes
Other Study ID Numbers: ABACAS1
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: February 2009

Keywords provided by Speciality European Pharma Limited:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs