A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
ICELAND
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
2 other identifiers
interventional
706
10 countries
71
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Mar 2006
Typical duration for phase_3 prostate-cancer
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 19, 2006
CompletedFirst Posted
Study publicly available on registry
September 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 4, 2014
June 1, 2014
5.3 years
September 19, 2006
June 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to PSA progression
3 Years
Secondary Outcomes (5)
Overall survival
5 Years
World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status
3 Years
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25
3 Years
Time to serum testosterone > 50 ng/dL
3 Years
Change in progression biomarkers (some sites)
3 Years
Study Arms (2)
Continuous Androgen Deprivation (CAD)
ACTIVE COMPARATORIntermittent Androgen Deprivation (IAD)
EXPERIMENTALInterventions
LHRH antagonist
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Unknown Facility
Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Brussels, Belgium
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Leuven, B-3000, Belgium
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Liège, 4000, Belgium
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Bmo, 65691, Czechia
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Jablonec nad Nisou, 46660, Czechia
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Olomouc, 7521, Czechia
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Ústí nad Labem, 40113, Czechia
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Joensuu, FIN-80210, Finland
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Tampere, FIN-33521, Finland
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Avignon, 84000, France
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Bordeaux, 33073, France
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Brest, 29609, France
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Caen, 14033, France
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Cergy-Pontoise, 95301, France
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Grenoble, 38043, France
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Marseille, 13915, France
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Nantes, 44093, France
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Paris, 75007, France
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Paris, 75014, France
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Paris, 94275, France
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Pierre-Bénite, 69310, France
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Ploemeur, 53275, France
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Rouen, 76031, France
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Suresnes, 92151, France
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Toulon, 83000, France
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Toulouse, 31054, France
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Bad Neuenaher, 53474, Germany
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Bautzen, 02625, Germany
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Dresden, 01307, Germany
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Dresden, 01324, Germany
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Hagenow, 19230, Germany
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Halle, 06132, Germany
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Hettstedt, 06333, Germany
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Leipzig, 04105, Germany
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Neustadt in Sachsen, 01844, Germany
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Trier, 54290, Germany
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Budapest, 1106, Hungary
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Kaposvár, 7400, Hungary
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Nyíregyháza, 4400, Hungary
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Szolnok, 5000, Hungary
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Tatabánya, 2800, Hungary
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Veszprém, 8200, Hungary
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Bergamo, Bergamo, 24128, Italy
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Bologna, Bologna, 40138, Italy
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Desio, Milano, 20033, Italy
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Parma, Parma, 43100, Italy
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Roma, Roma, 00189, Italy
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Ancona, Italy
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Bari, Italy
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Chieti, Italy
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Messina, Italy
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Milan, Italy
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Moscow, 115478, Russia
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Moscow, 125101, Russia
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Moscow, 125284, Russia
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Saint Petersburg, 198013, Russia
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Saint Petersburg, 198255, Russia
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Martin, 03659, Slovakia
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Skalica, 90982, Slovakia
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Trenčín, 91101, Slovakia
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Alcorcón, Madrid, 28922, Spain
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A Coruña, Spain
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Barcelona, 8003, Spain
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Barcelona, 8035, Spain
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Barcelona, 8036, Spain
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Granada, Spain
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Madrid, 28041, Spain
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Madrid, Spain
Unknown Facility
Valencia, 46009, Spain
Related Publications (2)
Tombal B, Cornel EB, Persad R, Stari A, Gomez Veiga F, Schulman C. Clinical Outcomes and Testosterone Levels Following Continuous Androgen Deprivation in Patients with Relapsing or Locally Advanced Prostate Cancer: A Post Hoc Analysis of the ICELAND Study. J Urol. 2017 Nov;198(5):1054-1060. doi: 10.1016/j.juro.2017.05.072. Epub 2017 May 25.
PMID: 28552710DERIVEDSchulman C, Cornel E, Matveev V, Tammela TL, Schraml J, Bensadoun H, Warnack W, Persad R, Salagierski M, Gomez Veiga F, Baskin-Bey E, Lopez B, Tombal B. Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND). Eur Urol. 2016 Apr;69(4):720-727. doi: 10.1016/j.eururo.2015.10.007. Epub 2015 Oct 29.
PMID: 26520703DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2006
First Posted
September 21, 2006
Study Start
March 1, 2006
Primary Completion
June 1, 2011
Study Completion
December 1, 2012
Last Updated
June 4, 2014
Record last verified: 2014-06