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Completed

NCT Number: NCT00841113

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abarelix

Drug

100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter

Other names: Plenaxis

Goserelin plus Bicalutamide

Drug

Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months

Primary outcomes

  1. Early castration rates

    Time frame: One week

Secondary outcomes

  1. Maintenance of medical castration

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Speciality European Pharma Limited

Industry

Registry information

Official study 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.

Important dates

Study start
1999
Primary completion
2001
Study completion
2003
First posted
Feb 11, 2009
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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