Trial document




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  DRKS00003204

Trial Description

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Title

Non-interventional study for the analysis of efficacy and safety of EstraCept(R) 280 mg (Estramustin phosphate) at patients with castration resistant prostate cancer in three therapy situations

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Trial Acronym

EMPire

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Due to the increase of the incidence of prostate cancer as well as the death rate an increasing amount of patients enters the situation of hormone resistance after the initial therapy. The current non-interventional study is supposed to show that under EMP therapy in the situation of progressive metastatic disease a renewed increase of PSA can be delayed.

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Brief Summary in Scientific Language

By the application of Estramustin phospate (EMP) the positive effect on the castration resistant prostate cancer (CRPC) in 3 therapy situations shall be analyzed:
1. EMP as mono-therapy for cytostatic-naive patients with PSA-relapse after maximum androgen blockade.
2. EMP as a combination therapy with the cytostatic therapy of Docetaxel.
3. EMP as mono-therapy after termination of the cytostatic therapy with Docetaxel because of therapy refractory or because of abort of the cytostatic therapy as a result of toxicity or patient's request.

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Organizational Data

  •   DRKS00003204
  •   2011/08/03
  •   [---]*
  •   no
  •   Approved
  •   011/1560, Freiburger Ethik-Kommission International
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   1. Estramustin phosphate (EMP) as mono-therapy for cytostatic-naive patients with PSA-relapse after maximum androgen blockade.
    Initial dosis: Estracept(R) 280 mg: 3 x 1 hard capsule / day for 4 weeks. If there is a subjective improvement after 4 weeks, the therapy will be continued. Maintenance dosis: EstraCept(R) 280 mg: 2 x 1 hard capsule / day. If necessary (e.g. high weight) 3 x 1 hard capsule / day. Kind and duration of the therapy: If the initial therapy is successful, the therapy with EstraCept(R) must be permanently continued until objective progression.
  •   2. EMP as a combination therapy with the cytostatic therapy with Docetaxel.
    Initial dosis: Estracept(R) 280 mg: 3 x 1 hard capsule / day for 4 weeks. If there is a subjective improvement after 4 weeks, the therapy will be continued. Maintenance dosis: EstraCept(R) 280 mg: 2 x 1 hard capsule / day. If necessary (e.g. high weight) 3 x 1 hard capsule / day. Kind and duration of the therapy: If the initial therapy is successful, the therapy with EstraCept(R) must be permanently continued until objective progression.
  •   3. EMP as mono-therapy after termination of the cytostatic therapy with Docetaxel because of therapy refractory or because of abort of the cytostatic therapy as a result of toxicity or patient's request.
    Initial dosis: Estracept(R) 280 mg: 3 x 1 hard capsule / day for 4 weeks. If there is a subjective improvement after 4 weeks, the therapy will be continued. Maintenance dosis: EstraCept(R) 280 mg: 2 x 1 hard capsule / day. If necessary (e.g. high weight) 3 x 1 hard capsule / day. Kind and duration of the therapy: If the initial therapy is successful, the therapy with EstraCept(R) must be permanently continued until objective progression.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   [---]*
  •   [---]*
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Primary Outcome

Primary outcome of this non-interventional study of the therapy of Estramustin phosphate (EMP) is the analysis of an increase of overall survival in the situation of progressive metastatic disease and to which extent a renewed increase of PSA can be delayed.

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Secondary Outcome

• Overall survival of the patients under the different therapy strategies
• Impact on the quality of life measured by the PORPUS questionnaire
• Detection of adverse drug reactions and adverse events

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/08/15
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

• Castration resistant prostate cancer
• Advanced status
• Hormone refractory
• Signed patient informed consent

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Exclusion Criteria

As described in the product information

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Addresses

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    • PharmaCept GmbH
    • Mr.  Thomas   Schmidt 
    • Bessemerstr. 82
    • 12103  Berlin
    • Germany
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    • Urologische Abteilung Klinikum Landau-Süd
    • Mr.  Dr.  Andreas  Schlichter 
    • Danziger Straße 25
    • 76882  Bad Bergzabern
    • Germany
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    • OnkoDataMed GmbH
    • Mr.  M.Sc.  Heribert  Stiegler 
    • August-Borsig-Ring 37
    • 15566  Schöneiche b. Berlin
    • Germany
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Sources of Monetary or Material Support

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    • PharmaCept GmbH
    • Mr.  Thomas   Schmidt 
    • Bessemerstr. 82
    • 12103  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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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.