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A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD (ICELAND)
This study is ongoing, but not recruiting participants.
First Received: September 19, 2006   Last Updated: October 19, 2009   History of Changes
Sponsor: 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:


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

  Hide Study Locations
Locations
Belgium
Bruxelles, Belgium, 1200
Liege, Belgium, 4000
Brussel, Belgium
Bruxelles, Belgium, 1070
Leuven, Belgium, B-3000
Czech Republic
Bmo, Czech Republic, 65691
Jablonec nad Nisou, Czech Republic, 46660
Olomouc, Czech Republic, 7521
Usti nad Labem, Czech Republic, 40113
Finland
Tampere, Finland, FIN-33521
Joensuu, Finland, FIN-80210
France
Paris, France, 75007
Toulon, France, 83000
Suresnes, France, 92151
Paris, France, 94275
Caen-Cedex, France, 14033
Bordeaux, France, 33073
Nantes, France, 44093
Cergy-Pontoise, France, 95301
Avignon, France, 84000
Ploemeur, France, 53275
Brest, France, 29609
Grenoble, France, 38043
Rouen, France, 76031
Paris, France, 75014
Pierre-Benite, France, 69310
Marseille, France, 13915
Toulouse, France, 31054
Germany
Hagenow, Germany, 19230
Neustadt i. Sachsen, Germany, 01844
Dresden, Germany, 01324
Hettstedt, Germany, 06333
Trier, Germany, 54290
Bad Neuenaher, Germany, 53474
Bautzen, Germany, 02625
Halle/Saale, Germany, 06132
Leipzig, Germany, 04105
Dresden, Germany, 01307
Hungary
Szolnok, Hungary, 5000
Veszprem, Hungary, 8200
Kaposvar, Hungary, 7400
Budapest, Hungary, 1106
Tatabanya, Hungary, 2800
Nyiregyhaza, Hungary, 4400
Italy
Roma, Italy, 00189
Bari, Italy
Ancona, Italy
Messina, Italy
Chieti, Italy
Bergamo, Italy, 24128
Bologna, Italy, 40138
Parma, Italy, 43100
Milano, Italy
Italy, Milano
Desio, Milano, Italy, 20033
Russian Federation
St. Petersburg, Russian Federation, 198255
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 115478
St. Petersburg, Russian Federation, 198013
Moscow, Russian Federation, 125284
Slovakia
Martin, Slovakia, 03659
Skalica, Slovakia, 90982
Trencin, Slovakia, 91101
Spain
Barcelona, Spain, 8003
Valencia, Spain, 46009
Barcelona, Spain, 8035
Barcelona, Spain, 8036
Madrid, Spain, 28041
Granada, Spain
Madrid, Spain
La Coruna, Spain
Spain, Madrid
Alcorcon, Madrid, Spain, 28922
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: October 19, 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: Finnish Medicines Agency;   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

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 November 27, 2009