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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00378690

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: leuprorelin acetate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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

Enrollment:	706
Study Start Date:	March 2006
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: leuprorelin acetate LHRH antagonist
2: Experimental	Drug: leuprorelin acetate LHRH antagonist

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378690

Show 71 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Medical Affairs Europe, Astellas Pharma Europe Limited Lovett House

More Information

No publications provided

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	EGD-EC-003
Study First Received:	September 19, 2006
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00378690 History of Changes
Health Authority:	Austria: Ethikkommission; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Italy: Ethics Committee; Netherlands: Independent Ethics Committee; Poland: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Slovakia: State Institute for Drug Control; Spain: Ministry of Health; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Norway: Norwegian Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Astellas Pharma Inc:

Prostate Cancer
Prostate Specific Antigen

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide
Urogenital Neoplasms

Genital Diseases, Male
Hormones
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009