Abarelix Versus Goserelin Plus Bicalutamide in Patients W... | NCT00841113

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

NCT00841113

Sponsor

Speciality European Pharma Limited

Status

Completed

Last Update Posted

Feb 11, 2009Estimated

Enrollment

177Actual

Phase

Phase 3

Conditions

Prostate Cancer

Interventions

Abarelix
Goserelin plus Bicalutamide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Feb 2001Actual

Completion Date

Feb 2003Actual

First Submitted Date

Feb 10, 2009

First Submission Date that Met QC Criteria

Feb 10, 2009

First Posted Date

Feb 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2009

Last Update Posted Date

Feb 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

177Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 Abarelix	Experimental	Investigative drug	Drug: Abarelix
2 Goserelin plus bicalutamide	Active Comparator	Standard therapy	Drug: Goserelin plus Bicalutamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abarelix	Drug	100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter	1 Abarelix

Measure	Description	Time Frame
Early castration rates		One week

Measure	Description	Time Frame
Maintenance of medical castration		48 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frans M J Debruyne, MD	University Hospital Nijmegen	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C423508	abarelix
D017273	Goserelin
C053541	bicalutamide

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided