Trial document




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  DRKS00003569

Trial Description

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Title

Quality of life in patients with localised prostate cancer after either computerassisted surgery or radiotherapy with protons and photons.

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Trial Acronym

Protop

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URL of the Trial

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Brief Summary in Lay Language

We want to compare quality of life in prostate cancer patients undergoing two different therapies. One therapy is a computerassisted surgery, the other is radiotherapy with protons and photons.
We want to find out if patients differ in their quality of life parameters within one year after therapy.

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Brief Summary in Scientific Language

Besides other options patients with localised prostate cancer can choose between radical prostatectomy and external beam radiation therapy. Both therapies have similar success rates.
In Heidelberg two up-to-date methods: computerassisted surgery and radiotherapy with protons and photons are implemented.
Aim of this study is to randomise patients to one of these methods and to evaluate possible differences in quality of life within one year after treatment. Secondary objectives are medical outcome, other aspects of quality of life and well-beeing of spouses. We also want to find out why patients participate in randomised studies.
The interdisciplinary project includes physicians, psychooncologists and statisticians of different departements of the University Clinic Heidelberg.

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Organizational Data

  •   DRKS00003569
  •   2012/03/06
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  •   yes
  •   Approved
  •   S-008/2012, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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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

  •   computerassisted surgery
  •   radiotherapy with protons and photons
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Quality of life after treatment and after 2 weks, 3, 6, 9 and 12 month. Questionnaires: EORTC-C30, EORTC-PR25, ICS, IIEF5, PHQ, CCAT-P.

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Secondary Outcome

Before, directly after and 2 weeks, 3 month, 6 month ans 1 year after treatment:
Biochemical relapse-free prostate-specific survival
Side effects (ICS, IIEF5)
Depression (PHQ)
Anxiety (PHQ)
Contentment (Distress-scale, CCAT-P, interview)
fear of progression (PA-F-KF)
Contentment of spouse (Distress-scale, EPIC, PHQ, interview)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2012/04/12
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   40   Years
  •   75   Years
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Additional Inclusion Criteria

1. ECOG Performance Status 0 or 1
2. informed concent
3. prostate cancer (<cT3, PSA<20 ng/ml, Gleason-Score<8)
4. ability to read and answer German questionnaires

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Exclusion Criteria

1. Medical reasons against one of the therapies
2. Other treatments of prostate cancer
3. Metastases
4. Life expectancy < 5 years
5. Patients with legal guardian
6. Participation in other studies that could influence the results
7. Cardiac pacemaker

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Addresses

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Sources of Monetary or Material Support

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    • Europäische Stiftung für Urologie Heidelberg (EFU)
    • INF 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting withdrawn before recruiting started
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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.