Trial document




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  DRKS00000024

Trial Description

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Title

An Open-Label, Randomised, Multi-Centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients with Prostate Cancer Treated for 12 Months / FE 200486 CS12

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

What is the purpose of the study?
Prostate cancer is a common disease in the male population with its incidence increasing significantly with age. Depending upon the size or spread, prostate cancer may be treated by surgery, radiotherapy or drugs. In many prostate cancers, the growth of cancer cells is stimulated by the hormone, testosterone. Reduction of testosterone can help to reduce cancer growth and spread. The study drug, degarelix, is an inhibitor of the hormone, gonadotropin-releasing hormone (GnRH). GnRH is released by a gland in the brain and plays a role in the release of testosterone. By reducing the amount of GnRH, degarelix causes testosterone levels to quickly fall to a very low level.
Several drugs similar to degarelix are licensed für the treatment of prostate cancer and have beeil widely used. Their main disadvantage is that before they reduce level of GnRH and consequently testosterone, they cause an increase of GnRH level, which lasts für a period of approximately 2 weeks. Thus prostate cancer can be stimulated to grow and spread für a period of time, and the patients frequently experience an increase in cancer symptoms such as rain in the bones. It is hoped that the treatment with degarelix would avoid this.
The purpose of this study is to find an optimal dose and 10 further investigate the efficacy and safety of six different dosing regimens up to 12 months of treatment with the study drug, degarelix. Approximately 180 patients will participate in this study. The patients will be recruited from about 40 clinics specialised in treatment of prostate cancer.

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Brief Summary in Scientific Language

Overall Design and Control Methods
This study is an open-Iabel, randomised, multi-centre, parallel group study investigating the efficacy and safety of six different dosing regimens of degarelix administered subcutaneously to patients with prostate cancer.
A total of 180 patients will be randomised and exposed to degarelix in a total of six treatment groups.
Patients will initially be enrolled for a study period of 13 treatment cycles made up of all cycles of Initial Dose (200 mg or 240 mg) and 12 Cycles of Maintenance Therapy (80 mg, 120 mg or 160 mg). Each cycle is 28 days lang. Patients will be randomised to receive all of the six degarelix dosing regimens, the dosing regimens are illustrated in Figure I.
Patients who meet the appropriate prospective criteria as determined by the investigator and Ferring Pharmaceuticals AIS after their 13 treatment cycles will be offered the opportunity to receive long-term treatment and support in the planned extension study FE200486 CSI2A (see separate protocol for more information).

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Organizational Data

  •   DRKS00000024
  •   2008/09/05
  •   2004/01/15
  •   no
  •   Approved
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Secondary IDs

  •   UKF000001  (UKFReg)
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   1st round:
    1.Examination of the injection area
    2.Injection: 200 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
    2nd round:
    1.Examination of the injection area
    2.Injection: 80 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
  •   1st round:
    1.Examination of the injection area
    2.Injection: 200 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
    2nd round:
    1.Examination of the injection area
    2.Injection: 120 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
  •   1st round:
    1.Examination of the injection area
    2.Injection: 200 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
    2nd round:
    1.Examination of the injection area
    2.Injection: 160 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
  •   1st round:
    1.Examination of the injection area
    2.Injection: 240 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
    2nd round:
    1.Examination of the injection area
    2.Injection: 80 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
  •   1st round:
    1.Examination of the injection area
    2.Injection: 240 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
    2nd round:
    1.Examination of the injection area
    2.Injection: 120 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.EGK
    7.Physical examination
  •   1st round:
    1.Examination of the injection area
    2.Injection: 240 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
    2nd round:
    1.Examination of the injection area
    2.Injection: 160 mg Degarelix
    3.Examination of the injection area
    4.Urine and blood tests
    5.Measurement of pulse and blood pressure
    6.ECG
    7.Physical examination
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Parallel
  •   II
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Primary Outcome

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Histological confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This inc1udes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention.
Male patient aged 18 years or over.
Has a baseline testosterone above the lower limit ofnorma1 range.
Has an ECOG (Eastern Co-operative Oncology Group) score of 2 (see Appendix II).
Has a PSA value of 2ng/mL.
Has a life expectancy of at least 6 months.

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Exclusion Criteria

Any patient meeting one or more of the following exc1usion criteria will not be entered into the study:
Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, oestrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is accepted for a maximal duration of 6 months. This treatment should have been terminated at least 6 months prior to Screening Visit.
Currently or recently (within the last 12 weeks preceding Screening Visit) under treatment with any ether drug modifying the testosterone level or function (please see examples listed in Appendix III).
Is considered to be candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
Has a history of severe asthma (defined as a need for daily treatment with inhalation steroids to control the asthma), anaphylactic reactions, angioderma, angioneurotic oedema or Quincke Oedema.
Has hypersensitivity towards any component 0 f the investigational products (degarelix or mannitol).
Has history of ether cancer within the last 5 years except from prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
Has elevated serum ALT level more than three times above tipper level of normal range or serum total bilirubin level above all and a half above tipper level of normal range as measured by the laboratory at the Screening Visit.
Has a known hepatic disease.
Has either clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the patient`s participation in this study or evaluation of study results.
Has a clinically significant disorder or any ether condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion ofthe study as judged by the investigator. Patients with symptomatic prostate cancer may participate in the study
Has a mental incapacity or language precluding adequate understanding or co-operation.
Has received an investigational drug within the last 12 weeks preceding Screening Visit.
Has previously participated in any degarelix study.

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Addresses

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    • Endocrine Oncology Ferring Pharmaceuticals A/S
    • Kay Fiskers Plads 11
    • DK-2300  Copenhagen
    • Denmark
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    • Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med.  Wolfgang  Schultze-Seemann 
    • Hugstetter Straße 55
    • D-79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med.  Wolfgang  Schultze-Seemann 
    • Hugstetter Str. 55
    • D-79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

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