Trial document



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  DRKS00003256

Trial Description

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Title

Prospective Randomized Study to Compare a Limited versus Extended Pelvine Lymphadenectomy during Prostatectomy - SEAL - AP 55/09

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Trial Acronym

SEAL

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URL of the Trial

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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 (PSA-Progress)

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003256
  •   2012/01/20
  •   2011/08/05
  •   yes
  •   Approved
  •   2010220, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   NCT01555086  (clinicaltrials.gov)
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   Prostate Cancer
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Interventions/Observational Groups

  •   Limited pelvine Lymphadenectomy
  •   Extended pelvine Lymphadenectomy
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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
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Primary Outcome

PSA-progresse within 5 years, 3-monthly Follow-up with PSA-measurement in blood

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Secondary Outcome

- Comparison of overall survival and morbidity after limited versus extended lymphadenectomy within 5 years after prostatectomy
- 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 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2011/08/16
  •   500
  •   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

- 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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    • Univsitätsklinikum Essen
    • Ms.  Dr.  Katrin  Weidler 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Uniklinik Köln, Klinik und Poliklinik für Urologie
    • Mr.  Prof. Dr.  Axel  Heidenreich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, Klinik 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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    • Arbeitsgemeinschaft Urologische Onkologie (AUO) in der Deutschen Krebsgesellschaft e. V.
    • Seestr. 11
    • 17252  Schwarz
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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