Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
NCT ID: NCT01555086
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2011-08-31
Brief Summary
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Detailed Description
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Both extensions of lymphadenectomy are used in hospitals as a free choice. This study shell show if one method is more effective than the other.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Limited pelvic Lymphadenectomy
Limited pelvic Lymphadenectomy
approximately 10-14 lymph nodes are removed
Extended pelvic Lymphadenectomy
Extended pelvic Lymphadenectomy
approximately 20 lymph nodes are removed
Interventions
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Limited pelvic Lymphadenectomy
approximately 10-14 lymph nodes are removed
Extended pelvic Lymphadenectomy
approximately 20 lymph nodes are removed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
MALE
No
Sponsors
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Association of Urologic Oncology (AUO)
OTHER
Responsible Party
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Locations
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Krankenhaus Maria Hilf
Krefeld, Dießemer Bruch 80, Germany
Martiniklinik am UKE
Hamburg, Martinistraße 52, Germany
St. Antonius-Krankenhaus
Gronau, Möllenweg 22, Germany
Städtisches Klinikum Fulda
Fulda, Pacelliallee 3-5, Germany
RWTH Aachen
Aachen, Pauwelsstraße 30, Germany
Countries
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Central Contacts
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Axel Heidenreich, Prof. Dr.
Role: CONTACT
Facility Contacts
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Other Identifiers
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DRKS00003256
Identifier Type: REGISTRY
Identifier Source: secondary_id
AP 55/09
Identifier Type: -
Identifier Source: org_study_id
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