NCT00841113

CompletedPhase 3

Abarelix Versus Goserelin Plus Bicalutamide in Patients With...

Speciality European Pharma Limited Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

ABACAS1

Study Type

interventional

Actual enrollment (reported)

177

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 1999

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2001

Actual (reported)

Study Completion

February 2003

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 177 participants
Study completion date: February 2003
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1999
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 2001
Actual (reported)
Study Completion
February 2003
Actual (reported)
First Submitted
February 10, 2009
Actual (reported)
First Posted
February 11, 2009
Actual (reported)

Last Updated: February 11, 2009
Status Verified: February 2009
Last Update Submitted: 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

Sponsors & Collaborators

Speciality European Pharma Limited
Industrylead

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Interventions

abarelixGoserelinbicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

Frans M J Debruyne, MD
University Hospital Nijmegen
PRINCIPAL INVESTIGATOR

Enrollment

177 participants (actual enrollment reported by the registry).

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 1999

Date type not reported

This date has not been verified as actual or estimated.

Completed

NCT00767286

Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

Phase 3Completed

NCT00004635

Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer

Phase 3Completed

NCT00003653

Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

Phase 3Completed

NCT00003682

Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer

Phase 3Terminated

NCT00005947

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 3Completed

NCT00003734

Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

Phase 3Unknown

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Neoplastic Processes

Pathologic Processes

Pathological 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

Primary Completion

February 2001

Actual (reported)

Study Completion

February 2003

Actual (reported)

Last Updated

February 11, 2009

Record last verified: 2009-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00841113
Data provider: ClinicalTrials.gov
Source updated: 2009-02-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:08 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1 Abarelix

2 Goserelin plus bicalutamide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record