Trial document





This trial has been registered retrospectively.
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  DRKS00015288

Trial Description

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Title

Feasibility-study of Lifestyle-Intervention for patients with local advanced prostate cancer

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The risk for recurrence for patients with local advanced non-metastatic prostate cancers with Gleason score higher than 4+3 after radical prostatectomy is even more than 50 % without a proven benefit for adjuvant therapy. Epidemiology studies showed a potential influence from lifestyle factors like nutrition, physical activity and intake of supplementations of prostate cancer incidence, aggressiveness and maybe follow up.
This intervention trail for patients with high risk prostate cancer after radical prostatectomy should investigate the influence of changing lifestyle factors of risk for biochemical recurrence. This feasibility study should give essential information about the practicability for a controlled and randomised trial in future.

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Brief Summary in Scientific Language

Monocentric, non-randomised feasibility study of the influence of lifestyle factors for biochemical recurrence after radical prostatectomy for patients with local advanced prostate cancer

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Organizational Data

  •   DRKS00015288
  •   2018/08/27
  •   [---]*
  •   yes
  •   Approved
  •   PV5358, Ethik-Kommission der Ärztekammer Hamburg
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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

  •   10 week course with changing of nutrition habits, physical sports training program and education of meditation technics for patients after radical prostatectomy
  •   Patients after radical prostatectomy without an offered course of lifestyle interventions (Martini-Cohort).
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Significant decrease of biochemical recurrence rate after radícal prostatectomy aftre 6, 12 and 18 months after Intervention by measurement of PSA in blood

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Secondary Outcome

• How many patients are disposed to the intervention program? How good is the adherence to the program (attendance list)?

Before and after the intervention (directly at the end of the Intervention, after 6 months, after 12 months and after 18 months) by Food­ Frequency-Questionnaire of the EPIC-Study (European Prospective lnvestigation into Cancer), Physical Activity Questionnaire of EPIC-Study (European Prospective lnvestigation into Cancer), NutRiCaP (Nutrition Risk Assessment in Prostate Cancer Patients) and measurement of bodycomposition by BIA, Level of physical activity with accelerometer and 6-Minute-Walking-test:
• How effective is the program for long-term lifestyle changing?
• How effective is the program for physical activity and fitness? Can we messure the effects in changing of the body composite?
• How effective is the program for changing of nutrition habits?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/12/09
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

High risk prostate cancer at least pT3 pN0 R0 and minimum Gleason 3+4

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Exclusion Criteria

No planed adjuvant therapy

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf, Martini-Klinik am UKE GmbH
    • Ms.  Dr.  Imke  Thederan 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Ambulanzzentrum des UKE GmbH
    • Mr.  Stefan  Patra 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Martini-Klinik am UKE GmbH
    • Ms.  Dr. med.  Imke  Thederan 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Martini-Klinik am UKE GmbH
    • Ms.  Dr. med.  Imke  Thederan 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Heinrich Warner Stiftung
    • Corinthstr. 21
    • 22605  Hamburg
    • Germany
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    •   040 8812518
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    • Hamburger Krebsgesellschaft e.V.
    • Butenfeld 18
    • 22529  Hamburg
    • Germany
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    •   040 4134 75680
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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