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Trial · Interventional

CompletedPhase 3Registry data

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

Short name ICELAND

NCTNCT00378690 (opens ClinicalTrials.gov in a new tab)Other idEGD-EC-003Other id2005-004094-25Other id2005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
706 participants (actual)
Sponsor
Astellas Pharma Inc · Industry
Design
Randomized · Open label (no masking)
Countries
10 countries

Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Russia, Slovakia, Spain

Start
Mar 2006
Primary completion
Jun 2011
Completion
Dec 2012
First posted
21 Sept 2006 (estimated)
Last update posted
4 Jun 2014 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 3

    ICELAND

    NCT00378690

    Mar 2006 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • leuprorelin acetateDrug

Arms2

  • Active comparator

    Continuous Androgen Deprivation (CAD)

  • Experimental

    Intermittent Androgen Deprivation (IAD)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to PSA progression

    Time frame · 3 Years

Secondary outcomes(5)

  1. Overall survival

    Time frame · 5 Years

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

    Time frame · 3 Years

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

    Time frame · 3 Years

  4. Time to serum testosterone > 50 ng/dL

    Time frame · 3 Years

  5. Change in progression biomarkers (some sites)

    Time frame · 3 Years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

8 results

Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND).

Schulman et al. 2016European urologycited by 37

PMID 26520703DOI 10.1016/j.eururo.2015.10.007PUB-26520703

Full text at the publisher8 results
Publisher pageSee results (8)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2017

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.

Tombal et al. 2017The Journal of urologycited by 13

PMID 28552710DOI 10.1016/j.juro.2017.05.072PUB-28552710

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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