Trial document




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  DRKS00009594

Trial Description

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Title

Non-interventional study to the investigation of the quality of life in patients on Politrate Depot

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Trial Acronym

NIS Politrate Depot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Within the scope of this non-interventional study should be investigated the impact of treatment on the patient`s quality of life.
Politrate Depot is a LHRH analogue (drug substance which has a structure similar to a hormone that is formed in a part of the interbrain (hypothalamus). Politrate Depot is indicated for the palliative treatment of advanced hormone-dependent prostate cancer.
Politrate Depot 22.5 MG should be administered by dint of injection into a muscle at intervals of three months.
The dose of Politrate Depot 22.5 MG is provided in a specific form that allows the continuous release of leuprorelin over a period of three months.
The response to the politrate depot therapy should be monitored by means of regular measurements of serum testosterone level and of PSA values.
Usually the therapy of advanced prostate cancer requires a long-term treatment. If a regression or improvement will occur, the therapy should not be discontinued.

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Brief Summary in Scientific Language

Rationale: The collection of data on quality of life by means of validated PORPUS- questionnaires (Patient ORiented Prostate Cancer Utility Scale) when administering Politrate Depot in patients with hormone-dependent advanced prostate cancer.
Indication: Politrate Depot is indicated for the palliative treatment of hormone-dependent advanced prostate cancer.
Treatment: Patients will be treated according to the summary of product characteristics Politrate Depot.
The recommended dose of Politrate Depot is 22.5 MG and is available in a threemonthly depot injection form. Politrate Depot will be administered intramuscularly every three month.
The response to Politrate Depot therapy is to monitor with regular measurements of serum testosterone level and of PSA values.
If the treatment response seems to have become suboptimal, it is advisable to ensure that the serum testosterone level has reached castration level or remained at this level. A temporary increase of acid phosphatase value appears sometimes at the beginning period of treatment. However the values decrease again to normal or almost normal levels from the fourth week of treatment.
Usually the therapy of advanced prostate cancer requires a long-term treatment. If a regression or improvement will occur, the therapy should not be discontinued.
Statistical aspects: The evaluation of collected data on quality of life, efficiency and safety will be analysed with descriptive statistics.
Variable characteristics will be represented by number of observations, average, standard deviation, minimum, median and maximum. Categorial characteristics will be represented by absolute and relative frequencies within each category.
For the evaluation of longitiduale parameters with partly censored information will be used the Kaplan-Meier estimator.
The severity level, absolute and relative frequencies of all adverse events will be represented.

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Organizational Data

  •   DRKS00009594
  •   2015/11/19
  •   [---]*
  •   no
  •   Approved
  •   Eth-47/15, Ethik-Kommission der Ärztekammer Berlin
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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

  •   For the participating patients the change of quality of life as part of the Lutrate(R) therapy will be determined over a period of 9 months compared to the baseline.
    For that the PORPUS-questionnaire is used.
    The questionnaire needs to be filled out by the patients before start of therapy, as part of the first, the second (3 months after enrollment) and the fourth (9 months after enrollment) medication with Lutrate(R) Depot.
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Characteristics

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

Collection on the change of the quality of life using the PORPUS-Questionnaires (Patient ORiented Prostate Utility Scale) during the Lutrate(R)-therapy over the period of therapy in comparison to the baseline.
Measurement time: before start of therapy, as part of the first, the second (3 months after enrollment) and the fourth (9 months after enrollment) medication with Lutrate(R) Depot.

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Secondary Outcome

• Collecting safety data
• Evaluation of the effectiveness of the treatment according to the course of PSA values and testosterone level (if existing)
• Analysis of specifically prostate cancer anamnesis data
• evaluation of the efficacy of treatment and of therapy by the physician
• determination of adverse drug effects / adverse events;

The evaluation by the doctor is done one time at the end of the observation as part of the "Follow Up". The doctor carries out the overall assessment of therapy in relation to efficacy and compatibility. In this connection he chooses between five possible answers, which are documented in the eCRF (very good, good, medium, rather bad, insufficient).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2015/12/01
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

• male patient
• Signed patient consent form
• Age: ≥ 18 Years
• advanced, hormone-sensitive prostate carcinoma

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Exclusion Criteria

• hypersensitivity to the active substances, to any of the excipients or to one of the other ingredients of politrate according to the summary of product characteristics

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Addresses

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    • ribosepharm division Hikma Pharma GmbH
    • Lochhamer Straße 13
    • 82152  Martinsried
    • Germany
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    •   089 45450304
    •   08945450466
    •   [---]*
    •   [---]*
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    • ribosepharm divisionHikma Pharma GmbH
    • Ms.  Beate  Zuzan 
    • Lochhamer Str. 13
    • 82152  Martinsried
    • Germany
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    • ONKODATAMED GmbH
    • Ms.  Anna  Merk 
    • Friedenstraße 58
    • 15366  Neuenhagen bei Berlin
    • Germany
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Sources of Monetary or Material Support

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    • ribosepharm division Hikma Pharma GmbH
    • Lochhamer Schlag 17
    • 82166  Gräfelfing
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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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.