Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004016

Trial Description

start of 1:1-Block title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ICELAND

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004016
  •   2013/01/09
  •   2006/09/19
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2005-004094-25 
  •   NCT00378690  (ClinicalTrials.gov)
  •   EGD-EC-003  (Astellas Pharma Inc)
  •   2005-004094-25 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: leuprorelin acetate
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Time to PSA progression; time frame: 3 Years

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Overall survival; time frame: 5 Years
- World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status; time frame: 3 Years
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and QLQ-PR25; time frame: 3 Years
- Time to serum testosterone > 50 ng/dL; time frame: 3 Years
- Change in progression biomarkers (some sites); time frame: 3 Years

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Belgium
  •   Czech Republic
  •   Finland
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Russian Federation
  •   Slovakia
  •   Spain
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2006/03/31
  •   706
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Astellas Pharma Inc
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive
    • Central Contact 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medical Affairs Europe, Astellas Pharma Europe Limited Hillswood Drive
    • Central Contact 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/12/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.