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

This study has been completed.
Sponsor:
Information provided by:
Speciality European Pharma Limited
ClinicalTrials.gov Identifier:
NCT00841113
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Speciality European Pharma Limited:

Primary Outcome Measures:
  • Early castration rates [ Time Frame: One week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maintenance of medical castration [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841113

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

No publications provided

Responsible Party: Speciality European Pharma Limited, SEP
ClinicalTrials.gov Identifier: NCT00841113     History of Changes
Other Study ID Numbers: ABACAS1
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Speciality European Pharma Limited:
Prostate cancer
Advanced
Metastatic

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Bicalutamide
 Abarelix
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013