Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012763

Trial Description

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Title

Prospective Randomized Study to Compare a Limited versus Extended Pelvine Lymphadenectomy during Prostatectomy - AP 77/13 of AUO

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Trial Acronym

SEAL-2

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URL of the Trial

http://n.a.

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Brief Summary in Lay Language

This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.
Both extensions of lymphadenectomy are used in hospitals as a free choise. This study shell show if one method is more effective than the other.

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Brief Summary in Scientific Language

Influence of different extension of Lymphadenectomy to outcome of patients (Overall Survival)

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Organizational Data

  •   DRKS00012763
  •   2017/12/08
  •   [---]*
  •   yes
  •   Approved
  •   16-414, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Prostatakarzinom
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Limited pelvine Lymphadenectomy
  •   Extended pelvine Lymphadenectomy
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Characteristics

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

Overall Survival (OS) at 10 years

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Secondary Outcome

- Comparison of cancer specific survival, PSA-recidive-free survival, metastatic-free survavial and morbidity after limited versus extended lymphadenectomy
- Development of standard surgery procedures of the radical prostatectomy and lymphadenectomy as well as histopathological procedures for evaluation of tissues. For surgery therapy a precise definition of lymphnode fields that should be cleared within pelvine lymphadenectomy is very relevant. Also, the implementation of quality criteria like minimum account of lymphnodes to clear and definition of resection frames via additional tissue probes evaluation from resection frame. These standards shell be implemented into UICC-classification then.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/06/20
  •   902
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA > 10 ng/ml)

- locally-operable tumor according to DRU/TRUS
- ASA 1,2 and Charlson Comorbidity Score 0-1
- negative bone scan
- negative CT abdomen / pelvis
- general condition according to Karnofsky >/= 80%
- written consent of the patient
- adequate hematological, renal and coagulation physiological functions
- Patient compliance and geographic proximity to allow adequate follow-up

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Exclusion Criteria

- Manifest secondary malignancy
- Secured metastasis by histologically or by imaging
- Myocardial infarction or stroke within the last 6 months
- Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
- Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
- severe psychiatric disease
- prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
- previous pelvic radiotherapy
- Patients in a closed institution according to an authority or court decision
- People who are in a dependent relationship or working relationship with the sponsor or investigator
- simultaneous participation in another clinical trial

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Addresses

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    • Universitätsklinikum Köln
    • Mr.  Prof. Dr.  Axel  Heidenreich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Uniklinik KölnKlinik und Poliklinik für Urologie
    • Mr.  Prof. Dr.  Axel  Heidenreich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Uniklinik KölnKlinik und Poliklinik für Urologie
    • Mr.  Prof. Dr.  Axel  Heidenreich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • 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.