A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD - Tabular View

Tracking Information

First Received Date ^ICMJE

September 19, 2006

Last Updated Date

October 19, 2009

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to PSA progression [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00378690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD

Official Title ^ICMJE

A Phase IIIb Randomized Study of Intermittent Versus Continuous Androgen Deprivation Therapy Using ELIGARD 22.5 mg 3-month Depot in Subjects With Relapsing and Locally Advanced Prostate Cancer Who Are Responsive to Such Therapy

Brief Summary

Phase IIIb, Open-label, randomized, controlled multi-centre study. Induction therapy phase for 6 months where all subjects receive 2 ELIGARD depot injections. Those subjects with hormone responsive prostate cancer will be randomized and will receive either intermittent or continuous ELIGARD treatment for 36 months. Following this treatment period, subjects will enter a long-term follow-up period for 48 months.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Drug: leuprorelin acetate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

706

Estimated Completion Date

April 2011

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

At study entry (visit 1):

Written informed consent
Male subjects aged >=18 and <80 years old
Locally advanced (stage T3 or T4) prostate cancer or Relapsing prostate cancer following radical prostatectomy or,Relapsing prostate cancer following radiotherapy
Gleason score of >=6
ECOG performance status of 0-2.
Life expectancy at least 5 years

At randomization (visit 4):

Two successive decreasing serum PSA levels <=1 ng/ml

Exclusion Criteria:

At study entry (visit 1):

Any suspected second primary tumors
Evidence of metastatic disease
Other malignancy within the last 5 years except
Acute spinal cord compression, uni- or bilateral ureteric obstruction
Any concurrent biological response modifier therapy
Concurrent chemotherapy
Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy
Less than 6 months since prior 5-alpha reductase inhibitor treatment
Other concurrent hormonal therapy
Any concurrent radiotherapy
Testosterone at screening <= 1.7 mM or 50 ng/dL
Clinically significant elevation of serum creatinine or liver enzymes
Hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate
Hypersensitivity to CASODEXâ 50 mg.

Gender

Male

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Czech Republic, Finland, France, Germany, Hungary, Italy, Russian Federation, Slovakia, Spain

Administrative Information

NCT ID ^ICMJE

NCT00378690

Responsible Party

Disclosure Office Europe, Astellas Pharma Europe BV

Study ID Numbers ^ICMJE

EGD-EC-003

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Central Contact

Medical Affairs Europe, Astellas Pharma Europe Limited Lovett House

Information Provided By

Astellas Pharma Inc

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP