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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378690
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : June 4, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: leuprorelin acetate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Continuous Androgen Deprivation (CAD) Drug: leuprorelin acetate
LHRH antagonist
Other Name: ELIGARD 22.5 mg

Experimental: Intermittent Androgen Deprivation (IAD) Drug: leuprorelin acetate
LHRH antagonist
Other Name: ELIGARD 22.5 mg

Primary Outcome Measures :
  1. Time to PSA progression [ Time Frame: 3 Years ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378690

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Sponsors and Collaborators
Astellas Pharma Inc
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Study Director: Central Contact Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc Identifier: NCT00378690    
Other Study ID Numbers: EGD-EC-003
2005-004094-25 ( EudraCT Number )
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Keywords provided by Astellas Pharma Inc:
Prostate Cancer
Prostate Specific Antigen
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents