Trial document

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DRKS-ID: 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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Organizational Data

DRKS-ID: DRKS00003256
Date of Registration in DRKS: 2012/01/20
Date of Registration in Partner Registry or other Primary Registry: 2011/08/05
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 2010220, Ethikkommission der Ärztekammer Nordrhein

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Secondary IDs

Primary Registry-ID: NCT01555086 (clinicaltrials.gov)

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Health Condition or Problem studied

ICD10: C61 - Malignant neoplasm of prostate
Free text: Prostate Cancer

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Interventions/Observational Groups

Arm 1: Limited pelvine Lymphadenectomy
Arm 2: Extended pelvine Lymphadenectomy

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control (effective treament of control group)
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label Drug use: [---]*

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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

DE: Germany

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Locations of Recruitment

University Medical Center RWTH Aachen, Aachen
Medical Center St. Antonius-Hospital, Gronau
Medical Center Martini-Klinik, Hambrug
Medical Center Klinikum Fulda, Fula
Medical Center Krankenhaus Maria Hilf Krefeld, Krefeld

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2011/08/16
Target Sample Size: 500
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Male
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Univsitätsklinikum Essen
- Ms. Dr. Katrin Weidler
- Hufelandstr. 55
- 45147 Essen
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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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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- Telephone: 0221/478-82 094
- Fax: 0221/478-82 371
- E-mail: axel.heidenreich at uk-koeln.de
- URL: http://www.urologie.uk-koeln.de
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Contact for Public Queries
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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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- Telephone: 0221/478-82 094
- Fax: 0221/478-82 371
- E-mail: axel.heidenreich at uk-koeln.de
- URL: http://www.urologie.uk-koeln.de
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Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)
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- Arbeitsgemeinschaft Urologische Onkologie (AUO) in der Deutschen Krebsgesellschaft e. V.
- Seestr. 11
- 17252 Schwarz
- Germany
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- Telephone: 039827/79 677
- Fax: 039827/9 678
- E-mail: AUO at MeckEvidence.de
- URL: http://www.auo-online.de
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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