Trial document




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  DRKS00003069

Trial Description

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Title

Non-interventional study for recording the treatment and the influence on the treatment-specific quality of life with patients with hormone-refractory prostate cancer under a Docetaxel (Eurotere®) containing chemotherapy.

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Trial Acronym

ProQoLTere

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is the aim of this non-interventional study to record the impact of the efficacy and safety of a Docetaxel (Eurotere®) containing therapy with patients with hormone refractory prostate cancer on the disease specific quality of life and the course of the treatment. For this purpose the present analysis shall document the application of the taxane Docetaxel (Eurotere®) as part of the routine therapy and diagnosis of this disease. The quality of life data shall be collected with the validated Patient Oriented Prostate Cancer Utility Scale (PORPUS) at the beginning of the observation, after 3 months and after 9 months. The assessment of the safety occurs by means of the NCI CTC check list version 4.0 for the evaluation of objective adverse reactions (National Cancer Institute Common Toxicity Criteria). The assessment of the efficacy occurs by means of the objective responder rate.

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Brief Summary in Scientific Language

It is the aim of this non-interventional study to record the impact of the efficacy and safety of a Docetaxel (Eurotere®) containing therapy with patients with hormone refractory prostate cancer on the disease specific quality of life and the course of the treatment.
Target Parameters:
Safety by means of the NCI CTCAE criteria,
Disease specific quality of life,
Efficacy by means of the objective response,
Time to progression (TTP).
The quality of life data shall be collected with the validated Patient Oriented Prostate Cancer Utility Scale (PORPUS) at the beginning of the observation, after 3 months and after 9 months. This questionnaire contains 10 questions, 5 of which cover general domains of quality of life (questions 1 to 5: pain, energy, social support, emotional well-being, communication with the doctor) and 5 cover prostate specific areas (questions 6 to 10: urinary incontinence, urinary urgency, sexual function, sexual interest, intestinal symptoms). The format of the answers provides for 4- to 6-level categories.

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Organizational Data

  •   DRKS00003069
  •   2011/05/02
  •   [---]*
  •   no
  •   Approved
  •   011/1322, Freiburger Ethik-Kommission International
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Secondary IDs

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

  •   Hormone Refractory Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Routine treatment with Docetaxel, collection of data concerning quality of life at the beginning, after 3 and after 9 months, assessment of efficacy and safety.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Quality of life by means of the validated Patient Oriented Prostate Cancer Utility Scale (PORPUS) at the beginning of the observation, after 3 months and after 9 months.

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Secondary Outcome

Impact of the form of the therapy (mono, combination, application frequency) on the course of the therapy,
Impact of prior symptoms on the course of the therapy,
Predictive criteria for an improvement of the quality of life,
Collection of prognostic criteria,
Association between tumor response and treatment specific quality of life,
Evaluation of adverse drug reactions / events.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/07/04
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Histologically confirmed hormone-refractory prostate cancer.
Signed patient informed consent form.

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Exclusion Criteria

Other malignant diseases in the past 5 years,
Lack of compliance.

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Addresses

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    • Lapharm GmbH
    • Mr.  Rüdiger  Heffinger 
    • Wittelsbacherstr. 9
    • 83022  Rosenheim
    • Germany
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    • Mr.  Dr. med.  Götz   Geiges 
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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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    • Lapharm GmbH
    • Mr.  Rüdiger  Heffinger 
    • Wittelsbacherstr. 9
    • 83022  Rosenheim
    • 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.