Trial document




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  DRKS00004797

Trial Description

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Title

Impact of Docetaxel and Cabazitaxel on circulating neuroendocrine markers in castration resistant prostate cancer

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Trial Acronym

NEUTAX

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Docetaxel (Taxotere) and Cabazitaxel (Jevtana) are approved treatment options in castration resistant prostate cancer. How to measure the success of the chemotherapy apart from the PSA value is not known. The intent of the study is to test the neuroendocrine markers as possible candidates. These markers are excreted into the blood to a different extent within each patient. We also want to know how these markers behave under the chemotherapy.

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Brief Summary in Scientific Language

Docetaxel and Cabazitaxel are both approved drugs in castration resistant prostata cancer. Although the neuroendocrine pathway is known as one of the major escape mechanisms of CRPCa, very little knowledge exists about the response of neuroendocrine markers as CgA, NSE or proGRP on taxane-based chemotherapy. The objective of the study is to evaluate the taxane action on circulating serum levels of the neuroendocrine markers CgA, NSE and proGRP.

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Organizational Data

  •   DRKS00004797
  •   2013/03/07
  •   [---]*
  •   yes
  •   Approved
  •   2011-387N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  •   U1111-1140-3231 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   In 50 patients who receive Docetaxel 75 mg/m2 (3 weekly) or 35 mg/m2 (weekly) before the start of the chemotherapy, before cycle III. (75 mg/m2) and before cycle VI. (75 mg/m2) or at corresponding time points when 35 mg/m2 is given, the neuroendocrine marker (CgA, NSE and proGRP) and PSA are measured in blood samples.
  •   In 25 patients who receive Cabazitaxel before the start of the chemotherapy, before cycle III. and before cycle VI. the neuroendocrine markers (CgA, NSE and proGRP) and PSA are measured in blood samples.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   No
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Primary Outcome

Are the serum levels of the NE markers (CgA, NSE, ProGRP) significantly (30 % up or down) influenced by Docetaxel/Cabazitaxel chemotherapy (measured before the therapy, before the 3rd and before 6th cycle) compared to the pretherapeutic levels?

The PSA is measured the day it arrives (one day after bood withdrawal) in the reference laboratory (Synlab, Leinfelden) by the Siemens-system Centaur (method: LIA). The sample is frozen afterwards until the study is closed. All neuroendocrine markers are analysed after closure of the study by ELISA (company IBL) to reduce technical biases.

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Secondary Outcome

Does the pretherapeutic level of the marker, the decline or the increase during Docetaxel/Cabazitaxel therapy correlate with biochemical response and time to progression?

What are the best factors to predict the biochemical response/ time to progression for Docetaxel/Cabazitaxel?

Do the pretherapeutic neuroendocrine markers serve as a prognostic marker for disease specific survival?

What parameters influence the pretherapeutic levels of neuroendocrine circulating markers?

A biochemical response (for patients with a baseline PSA level of at least 20 ng per milliliter) is defined as a reduction from baseline of at least 50 percent that was maintained for at least three weeks, whereas PSA progression was defined as an increase from the nadir of either at least 25 percent for men with no PSA response or at least 50 percent for all others. The duration of the PSA response is defined as the time between the first and the last evaluations at which the response criteria were met.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/03/06
  •   75
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Guideline conform planned treatment with Docetaxel or Cabazitaxel in castration resistant prostatate cancer

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Exclusion Criteria

- secondary malignancy under therapy within the past 5 years (not included low grade bladder cancer)
- neuroendocrine tumour in the past medical history

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Addresses

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    • Universitätsmedizin Göttingen, Klinik für Urologie
    • Mr.  PD Dr. med.  Elmar  Heinrich 
    • Robert-Koch-Str. 40
    • 37075  Göttingen
    • Germany
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    • Urologische Praxis
    • Mr.  Thorsten  Werner 
    • Ziegengasse 2
    • 37412  Herzberg
    • Germany
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    •   05521 - 71212
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    • Onkologische Gemeinschaftspraxis
    • Mr.  Dr. med.  Stefan  Fuxius 
    • Kurfürsten-Anlage 34
    • 69115  Heidelberg
    • Germany
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    •   06221 - 714990
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    • Klinikum Ludwigshafen, Klinik für Urologie
    • Mr.  Prof. Dr. med.  Markus  Müller 
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
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    • Universitätsmedizin Mannheim, Klinik für Urologie
    • Mr.  Dr. med.  Jost  von Hardenberg 
    • Theodor-Kutzner-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Universitätsmedizin Göttingen, Klinik für Urologie
    • Mr.  PD Dr. med.  Elmar  Heinrich 
    • Robert-Koch-Str. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsklinikum Mannheim, Klinik für Urologie
    • Ms.  Maike  Schwartz 
    • Theodor-Kutzner-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    •   06213832215
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    • Universitätsmedizin Mannheim, Klinik für Urologie
    • Mr.  Dr. med.  Jost  von Hardenberg 
    • Theodor-Kutzner-Ufer 1-3
    • 68167  Mannheim
    • Germany
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  • start of 1:1-Block address public-contact
    • Universitätsklinikum Mannheim, Klinik für Urologie
    • Ms.  Maike  Schwartz 
    • Theodor-Kutzner-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    •   06213832215
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Sources of Monetary or Material Support

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    • Sanofi-Aventis Deutschland GmbH Medical Oncology
    • Potsdamer Strasse 8
    • 10785  Berlin
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/01
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Trial Publications, Results and other Documents

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