Trial document




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  DRKS00003273

Trial Description

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Title

Space OAR™-pilot observational study - implementation in clinical practice

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Trial Acronym

Space OAR™- pilot observational study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The hydrogel polymer Space OAR™ was CE-certified for use as spacer for radiotherapy. The spacer is injected between prostate and rectal wall and displaces both organs by approximately 1cm. Consequently, the rectal wall is displaced out of the high radiation dose regions of prostate radiotherapy. Therefore, reduced rectal side effects are expected. The hydrogel is adsorbed after 4-6 months.
The aim of the observational study is to prospectively investigate the routine use Space OAR™ with regard to treatment-related toxicity (bladder, rectum, continence, potence) until ten years after radiation treatment of low/intermediate risk patients. Therefore, organ-related questionnaires are employed at routine follow-up visits. Furthermore, radiation dose calculations on initial cross-sectional imaging are performed to calculate the dose reductions/modifications mediated by the spacer. Clinical endpoints (toxicity concerning bladder, rectum, continence, potence, quality of life, health status) are correlated with calculated radiation dose modifications.

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Brief Summary in Scientific Language

The hydrogel polymer Space OAR™ was CE-certified (class 3 medical device) for use as spacer for radiotherapy. The spacer is injected between prostate and rectal wall and displaces both organs by approximately 1cm. Consequently, the rectal wall is displaced out of the high radiation dose regions of prostate radiotherapy. Therefore, reduced rectal side effects are expected. The hydrogel is adsorbed after 4-6 months.

The aim of the observational study is to prospectively investigate the routine use Space OAR™ with regard to treatment-related toxicity (bladder, rectum, continence, potence) until ten years after radiation treatment of low/intermediate risk patients. Therefore, organ-related questionnaires are employed at routine follow-up visits. Furthermore, radiation dose calculations on initial cross-sectional imaging are performed to calculate the dose reductions/modifications mediated by the spacer. Clinical endpoints (toxicity concerning bladder, rectum, continence, potence, quality of life, health status) are correlated with calculated radiation dose modifications.

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Organizational Data

  •   DRKS00003273
  •   2011/09/27
  •   [---]*
  •   yes
  •   Approved
  •   079/2011MPG23, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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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

  •   Patients with hydrogel injection before radiation treatment of low/intermediate risk prostae cancer
    are interviewed with questionaires in the first ten years after radiotherapy.
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Characteristics

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

Acute and chronic toxicity is measured weekly during radiotherapy and after three months. Therafter, patients are interviewed with questionaires annually. The questionaires evaluate toxicity regarding bladder, rectum, continence, potency and quality of life according to CTC or RTOG criteria and the quality of life questionaire of DKG (QoL, health status, continence score, potency score).

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Secondary Outcome

Radiation dose calculation of organs at risk in Gy for correlation with resulting side effects.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/10/10
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Routine application of Space OAR™ before radiation treatment
2. age of at least 18 years
3. unimpaired consciousness
4. ability to understand questionnaires
5. follow-uo at the institution

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Exclusion Criteria

None

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Addresses

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    • Universitätsklinikum Tübingen
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Radioonkologie
    • Mr.  Dr.  Arndt-Christian  Müller 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Radioonkologie
    • Ms.  Silke  Theden 
    • Hoppe-Seyler-Str. 3
    • 72076   Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Radioonkologie
    • Hoppe-Seyler-Str. 3
    • 72076   Tübingen
    • 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.