Trial document




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  DRKS00003135

Trial Description

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Title

Non-interventional study on the Management of Advanced Prostate Cancer with Triptorelin Pamoate Three Month Formulation (Pamorelin® LA 11.25 mg) or Six Month Formulation (Pamorelin® LA 22.5 mg) with a Focus on Quality of Life, using the PORPUS Questionnaire (Patient-orientated prostate utility scale)

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Trial Acronym

IQUOPAM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Important factors in the treatment of the advanced prostate cancer
are - besides achieving a castration level - to maintain or to improve
quality of life. The present non-interventional study, involving
approx. 600 subjects with advanced prostate cancer, is designed to
collect data on the management of advanced prostate cancer with a
focus on the quality of life of subjects treated with triptorelin
pamoate 3 month formulation (Pamorelin® LA 11.25 mg) or 6 month formulation (Pamorelin® LA 22.5 mg).
To collect these data a short specific Questionnaire will be used (validated German translation of the Canadian PORPUS questionnaire)

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Brief Summary in Scientific Language

To collect data on the quality of life of subjects with advanced
prostate cancer treated with triptorelin pamoate 3 month formulation or 6 month formulation and to assess the responder rate at month 6, using the PORPUS questionnaire
(Definition responder: Improvement ≥ 5 points in the total PORPUS scale)

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Organizational Data

  •   DRKS00003135
  •   2011/08/01
  •   [---]*
  •   no
  •   Approved
  •   011/1385, Freiburger Ethik-Kommission International
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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

  •   Routine therapy with 3- or 6-month formulation Triptorelin Pamoate. QoL questionnaire on day 1, month 6 and month 12.
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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

Primary objective(s)
To collect data on the quality of life of subjects with advanced
prostate cancer treated with triptorelin pamoate 3 month formulation or 6 month formulation and to assess the responder rate at month 6, using the PORPUS questionnaire. (Definition Responder: Improvement of ≥ 5 points in the PORPUS total scale).

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Secondary Outcome

Secondary objective(s)
1 To assess the responder rate at month 12 (definition: improvement of ≥ 5 points on the overall PORPUS scale)
2 To assess the changes of overall PORPUS scores at month
6 and at month 12 versus baseline
3 To assess the effectiveness of the treatment by the course of PSA and testosterone values within 6 and 12 months (if available).
The validity of the values is guaranteed by certified laboratories and the ring test certificates (“Ringversuchszertifikate”) for PSA and testosterone will be collected from the participating sites (see also the corresponding Guideline from the German Medical Association, “Richtlinien der Bundesärztekammer”, “Rili-Bäk”, current version 2010)
4 Analysis of medical history (using all available data as described in the section “Study Evaluations”)
5 To assess the change of Karnofsky Index within 6 and 12 months
6• To assess the change of tumour stadium (TNM) within 6 and 12 months
7 To perform subgroup analyses on quality of life and effectiveness data as a function of hormonal pretreatment
of subjects, resulting in separate subject groups, e.g. naïve for hormonal treatment, < 1 year, and ≥ 1 year hormonal pre-treatment (depending on the data structure)
8 To perform subgroup analyses on QoL data as a function of the applied formulation of Pamorelin at the beginning of the therapy and after 6 and 12 months(depending on the data structure)
9 To assess the global evaluation of overall effectiveness
by the physician by means of the Karnofsky Index at the beginning of the therapy and after 6 and 12 months.
10 To assess the global impression on tolerability by the
subject by means of the PORPUS questionnaire at the beginning of the therapy and after 6 and 12 months.
11 To assess the pain at injection site (Visual Analogue Scale / VAS) at the beginning of the therapy and after 6 and 12 months
12 To assess the subject satisfaction with therapy by means of the PORPUS questionnaire at the beginning of the therapy and after 6 and 12 months.
13 To assess the change of weight and BMI after 6 and 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/07/18
  •   600
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Eligible subjects should fulfill the following:
• Provision of written informed consent
• Male subjects aged 18 years and older with capacity to consent
• Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy or already receiving hormonal deprivation therapy (in this case, the preceding therapy and the reason for change of therapy have to be documented)
• Definition of locally advanced: T3 or T4 or N1 with any T, M0
• Definition of metastatic: any T, any N, M1

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Exclusion Criteria

As this is a non-interventional study, no exclusion criteria apply. The investigator has to follow the information in the SmPC, e.g. contraindications, restrictions, precautions.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ipsen Pharma GmbH
    • Ms.  Dr.  Christiane  Colling 
    • Einsteinstr. 30
    • 76275  Ettlingen
    • Germany
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    •   +49 (0) 7243 184 59
    •   +49 (0) 7243 184 680
    •   [---]*
    •   [---]*
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    • Ipsen Pharma GmbH
    • Ms.  Dr.  Christiane  Colling 
    • Einsteinstr. 30
    • 76275  Ettlingen
    • Germany
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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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    • Ipsen Pharma GmbH
    • Mr.  Dr.  Martin  Gerwe 
    • Einsteinstr. 30
    • 76275  Ettlingen
    • Germany
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    •   07243 184 31
    •   07243 184 680
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/09/06
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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.