Trial document





This trial has been registered retrospectively.
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  DRKS00013500

Trial Description

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Title

Pilot-study: Predicton of response on Lu177-radioligand therapy in metastatic prostate carcinoma by early serial PSA-value examination

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Trial Acronym

PCA-PSA-EPBR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In late stage, metastatic prostate cancer an "internal radiotherapy" may be applied.
This study investigates, whether it is possible to use blood tests on days 1-10 after date of therapy to predict a possible therapy success or not.

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Brief Summary in Scientific Language

In late stage, metastatic, castration refractory prostate carcinoma 177Lu-PSMA-617-radioligand therapy can be used as treatment. As biomarker for therapy success or failure PSA-serum values are assessed.
This study investigates whether changes of PSA-serum value on days 1-10 after date of therapy may give a prediction to therapy success (evaluated by PSA-serum value 4 weeks after therapy).

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Organizational Data

  •   DRKS00013500
  •   2017/12/01
  •   [---]*
  •   yes
  •   Approved
  •   504/16, 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

  •   On date of therapy and 1, 2, 3, 8 days after therapy PSA-serum values are determined and compared with the PSA-value 4 weeks after therapy.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Primary outcome is reached by determination of PSA-serum value on date of the control-examination 4 weeks after a therapy cycle

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/02
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Metastatic, castration refractory prostate carcinoma,
Lu177-PSMA-617-radioligand therapy planned

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Exclusion Criteria

No significant PSA-serum level = supposingly no PSA expression of tumor

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Klinik für Nuklearmedizin
    • Mr.  Dr. med.  Thomas  Faßbender 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Klinik für Nuklearmedizin
    • Mr.  Prof. Dr. med.  Juri  Ruf 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethik-Votum
  •   Studienprotokoll
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* This entry means the parameter is not applicable or has not been set.