MedDRA - Prostatakarzinom C61
Conditions
Interventions
Group 1: Limited pelvine Lymphadenectomy
Group 2: Extended pelvine Lymphadenectomy
Sponsors
Universitätsklinikum Köln
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) at 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Countries
Germany
Contacts
Public ContactAxel Heidenreich
Uniklinik KölnKlinik und Poliklinik für Urologie
Outcome results
None listed