Prostate Carcinoma, Salvage lymphadenectomy C61
Conditions
Interventions
Group 1: Salvage lymphadenectomy with radiation therapy
Group 2: Salvage lymphadenectomy without radiation therapy
Sponsors
Universitätsklinikum FreiburgKlinik für Urologie
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) capacity and patient compliance; 2) primary therapy prostate cancer (excluding z.n. radical prostatectomy) 3) presence of biochemical recurrence (PSA> 0,2ng/ml in two consecutive measurements at Z.n. radical prostatectomy) 4) Morphological imaging (excluded 68Ga-PSMA-PET / CT) suspencion of lymph node metastases (pelvis up including aortic bifurcation, solitary or multiple) 5) presence of imaging (excluded 68Ga-PSMA-PET / CT) for the diagnosis of lymph node metastasis (= 4 months old) 6) In case of antihormonal therapy these 4 weeks should be discontinued prior to planned salvage lymphadenectomy 7) Hematological, blood coagulation, hepatic and renal functions in the normal range (as part of the routine preparation for surgery)
Exclusion criteria
Exclusion criteria: 1) detection of distant metastases (Soft-tissue metastasis an/or bone metastases and/or visceral metastases, and/or lymph node metastases above the bifurcation) 2)radiotherapy as primary therapy 3) Untreated malignancies or evidence of another tumor, which limits the life expectancy of the patient leader 4) Charlson Comorbidity Index> 2 5) ECOG performance score> 1 6) myocardial infarction or apoplexy within the last 6 months 7) Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (f.e. severe bone marrow aplasia) disease 8) acute and chronic infection (f.e. HIV Ab test, HBs-Ag detection in serum and / or chronic hepatitis) 9) Severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution 10) Simultaneous participation in another clinical trial with interventional character (simultaneous participation in registry studies and / or non-interventional studies is allowed) 11) Subjects, who are standing in the work relationship / or relationship of dependency with Principal investigator or having any condition which, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCA Progression-free survival time; Radiological Progression-free survival time | — |
Secondary
| Measure | Time frame |
|---|---|
| - hormone therapy free survival; - Tumor-specific survival time; - Overall survival; - Drug toleranca, side effects and toxicity of salvage Lymphadenektomy and adjuvant radiation therapy | — |
Countries
Germany
Contacts
Public ContactKatrin Meumann
Universitätsklinikum Freiburg, Klinik für Urologie,Studiensekretariat
Outcome results
None listed