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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00378690
First received: September 19, 2006
Last updated: January 16, 2013
Last verified: January 2013
History of Changes

September 19, 2006
January 16, 2013
March 2006
June 2011   (final data collection date for primary outcome measure)
Time to PSA progression [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00378690 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25 [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • Time to serum testosterone > 50 ng/dL [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • Change in progression biomarkers (some sites) [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: leuprorelin acetate
LHRH antagonist
Other Name: ELIGARD 22.5 mg
  • Active Comparator: Continuous Androgen Deprivation (CAD)
    Intervention: Drug: leuprorelin acetate
  • Experimental: Intermittent Androgen Deprivation (IAD)
    Intervention: Drug: leuprorelin acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
706
December 2012
June 2011   (final data collection date for primary outcome measure)

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.
Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Italy,   Russian Federation,   Slovakia,   Spain
 
NCT00378690
EGD-EC-003, 2005-004094-25
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive
Astellas Pharma Inc
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP