Trial document




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  DRKS00013665

Trial Description

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Title

Response Assessement of Lutetium-177-PSMA-Targeted Radionuclide Therapy for Advanced Metastatic Prostate Cancer

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

PSMA-Targeted Radionuclide Therapy is a new and promising form of therapy in nuclear medicine, which is increasingly used for patients with advanced metastatic Prostate cancer. The molecular target is the 'prostate-specific membran antigen' (PSMA), which is highly expressed on the surface of most forms of prostate cancer cells.
By binding a beta-emitter like Lutetium-177 to this specific surface structure through a small protein, a highly selective exposure of tumor cells to radiation compared to the surrounding tissue is achievable. This highly palliative form of therapy is considered when other options are exhausted.
The PSMA-targeted radionuclide therapy can be quite effective even in this late state while providing acceptable side effects.
The goal of this study is to assess the effectiveness of this therapy by evaluating laborchemistry, imaging and clinical results of patients receiving this form of tratement in the Department of nuclear medicine Freiburg.

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Brief Summary in Scientific Language

retrospective assessement of PSMA therapy in advanced prostate cancer patients

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Organizational Data

  •   DRKS00013665
  •   2017/12/28
  •   [---]*
  •   yes
  •   Approved
  •   251/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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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

  •   the response of patients treated with Lutetium-177-PSMA-Targeted Radionuclide Therapy in the Department of nuclear medicine Universitätsklinikum Freiburg is evaluated on the basis of laborchemistry, imaging and clinical parameters
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Characteristics

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

evaluation of serologic and imaging response to Lutetium-177-PSMA-Targeted Radionuclide Therapy

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Secondary Outcome

assessement of clinical response to Lutetium-177-PSMA-Targeted Radionuclide Therapy (pain, quality of life)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/12/28
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients treated with Lutetium-177-PSMA-Targeted Radionuclide Therapy in the Department of nuclear medicine Universitätsklinikum Freiburg btween 07/15 and 12/17.

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Exclusion Criteria

patients for whom sufficient data acquisition could not be accomplished

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • University Clinic FreiburgDepartment of Nuclear Medicine
    • Mr.  PD Dr.  Juri  Ruf 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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    • University Clinic FreiburgDepartment of Nuclear Medicine
    • Mr.  PD Dr.  Juri  Ruf 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • University Clinic Freiburg, Department of Nuclear Medicine
    • Mr.  Prof. Dr.  Juri  Ruf 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • 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.