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

June 2, 2014 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

706

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Androgen Deprivation (CAD)
Drug: leuprorelin acetate
LHRH antagonist
Other Names:
  • ELIGARD 22.5 mg
Experimental: Intermittent Androgen Deprivation (IAD)
Drug: leuprorelin acetate
LHRH antagonist
Other Names:
  • ELIGARD 22.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to PSA progression
Time Frame: 3 Years
3 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 Years
5 Years
World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status
Time Frame: 3 Years
3 Years
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25
Time Frame: 3 Years
3 Years
Time to serum testosterone > 50 ng/dL
Time Frame: 3 Years
3 Years
Change in progression biomarkers (some sites)
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 19, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Estimate)

June 4, 2014

Last Update Submitted That Met QC Criteria

June 2, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGD-EC-003
  • 2005-004094-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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