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

This study has been completed.
Information provided by:
Speciality European Pharma Limited Identifier:
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

Condition Intervention Phase
Prostate Cancer Drug: Abarelix Drug: Goserelin plus Bicalutamide Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Speciality European Pharma Limited:

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

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

Enrollment: 177
Study Start Date: January 1999
Study Completion Date: February 2003
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00841113

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

Responsible Party: Speciality European Pharma Limited, SEP Identifier: NCT00841113     History of Changes
Other Study ID Numbers: ABACAS1
Study First Received: February 10, 2009
Last Updated: February 10, 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 processed this record on September 19, 2017