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Prostate CancerPhase 3ICELANDNCT00378690

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

A Phase 3 study testing leuprorelin acetate in people with Prostate Cancer, run by Astellas Pharma Inc at 71 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
leuprorelin acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
706 participants
Where
71 sitesin 10 countries
Study dates
Mar 2006to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • Life expectancy at least 5 years
  • At randomization (visit 4):
  • Two successive decreasing serum PSA levels <=1 ng/ml

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

71 sites in 10 countries.

71 sites in 10 countries

France17 sites

  • Study site

    Avignon, 84000

  • Study site

    Bordeaux, 33073

  • Study site

    Brest, 29609

  • Study site

    Caen, 14033

  • Study site

    Cergy-Pontoise, 95301

  • Study site

    Grenoble, 38043

  • Study site

    Marseille, 13915

  • Study site

    Nantes, 44093

  • Study site

    Paris, 75007

  • Study site

    Paris, 75014

  • Study site

    Paris, 94275

  • Study site

    Pierre-Bénite, 69310

  • Study site

    Ploemeur, 53275

  • Study site

    Rouen, 76031

  • Study site

    Suresnes, 92151

  • Study site

    Toulon, 83000

  • Study site

    Toulouse, 31054

Other trials in France

Germany10 sites

  • Study site

    Bad Neuenaher, 53474

  • Study site

    Bautzen, 02625

  • Study site

    Dresden, 01307

  • Study site

    Dresden, 01324

  • Study site

    Hagenow, 19230

  • Study site

    Halle, 06132

  • Study site

    Hettstedt, 06333

  • Study site

    Leipzig, 04105

  • Study site

    Neustadt in Sachsen, 01844

  • Study site

    Trier, 54290

Other trials in Germany

Italy10 sites

  • Study site

    Ancona

  • Study site

    Bari

  • Study site

    Bergamo, Bergamo, 24128

  • Study site

    Bologna, Bologna, 40138

  • Study site

    Chieti

  • Study site

    Desio, Milano, 20033

  • Study site

    Messina

  • Study site

    Milan

  • Study site

    Parma, Parma, 43100

  • Study site

    Roma, Roma, 00189

Other trials in Italy

Spain9 sites

  • Study site

    A Coruña

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Barcelona, 8003

  • Study site

    Barcelona, 8035

  • Study site

    Barcelona, 8036

  • Study site

    Granada

  • Study site

    Madrid, 28041

  • Study site

    Madrid

  • Study site

    Valencia, 46009

Other trials in Spain

Hungary6 sites

  • Study site

    Budapest, 1106

  • Study site

    Kaposvár, 7400

  • Study site

    Nyíregyháza, 4400

  • Study site

    Szolnok, 5000

  • Study site

    Tatabánya, 2800

  • Study site

    Veszprém, 8200

Other trials in Hungary

Belgium5 sites

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1200

  • Study site

    Brussels

  • Study site

    Leuven, B-3000

  • Study site

    Liège, 4000

Other trials in Belgium

Russia5 sites

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 125284

  • Study site

    Saint Petersburg, 198013

  • Study site

    Saint Petersburg, 198255

Other trials in Russia

Czechia4 sites

  • Study site

    Bmo, 65691

  • Study site

    Jablonec nad Nisou, 46660

  • Study site

    Olomouc, 7521

  • Study site

    Ústí nad Labem, 40113

Other trials in Czechia

Slovakia3 sites

  • Study site

    Martin, 03659

  • Study site

    Skalica, 90982

  • Study site

    Trenčín, 91101

Other trials in Slovakia

Finland2 sites

  • Study site

    Joensuu, FIN-80210

  • Study site

    Tampere, FIN-33521

Other trials in Finland

About this 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

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.

Conditions
Prostate Cancer
Being tested
leuprorelin acetate
Keywords
Prostate Cancer, Prostate Specific Antigen
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • leuprorelin acetateDrug

    Also called ELIGARD 22.5 mg

    LHRH antagonist

Study groups in NCT00378690
Study groupRoleWhat they receive
Continuous Androgen Deprivation (CAD)Active comparatorNot described
Receives: Drug: leuprorelin acetate
Intermittent Androgen Deprivation (IAD)ExperimentalNot described
Receives: Drug: leuprorelin acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to PSA progression

    Measured: 3 Years

Secondary outcomes (5)

  1. Overall survival

    Measured: 5 Years

  2. World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status

    Measured: 3 Years

  3. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25

    Measured: 3 Years

  4. Time to serum testosterone > 50 ng/dL

    Measured: 3 Years

  5. Change in progression biomarkers (some sites)

    Measured: 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJun 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
706 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00378690
Sponsor's protocol ID
EGD-EC-003
Other IDs
2005-004094-25, 2005
Acronym
ICELAND
Status last verified
Jun 2014
First submitted
19 Sep 2006
Last updated
4 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28552710

  • Schulman 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.

    PubMed 26520703

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing leuprorelin acetate in people with Prostate Cancer, run by Astellas Pharma Inc at 71 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in France, Germany, Italy, Spain, Hungary and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to PSA progression (time frame: 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00378690, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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