NCT00841113

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Jan 1999

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

2.1 years

First QC Date

February 10, 2009

Last Update Submit

February 10, 2009

Conditions

Prostate Cancer

Keywords

Prostate cancerAdvancedMetastatic

Outcome Measures

Primary Outcomes (1)

  • Early castration rates

    One week

Secondary Outcomes (1)

  • Maintenance of medical castration

    48 weeks

Study Arms (2)

1 Abarelix

EXPERIMENTAL

Investigative drug

Drug: Abarelix

2 Goserelin plus bicalutamide

ACTIVE COMPARATOR

Standard therapy

Drug: Goserelin plus Bicalutamide

Interventions

AbarelixDRUG

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

Also known as: Plenaxis
1 Abarelix
Goserelin plus BicalutamideDRUG

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

2 Goserelin plus bicalutamide

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

abarelixGoserelinbicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Frans M J Debruyne, MD

    University Hospital Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

January 1, 1999

Primary Completion

February 1, 2001

Study Completion

February 1, 2003

Last Updated

February 11, 2009

Record last verified: 2009-02