Salvage lymphadenectomy with or without adjuvant radiation therapy for prostate cancer recurrence - SALPRO

niversitätsklinikum FreiburgKlinik für Urologie0 个研究点目标入组 1 人开始时间: 2018年5月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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)

•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).

发起方

niversitätsklinikum FreiburgKlinik für Urologie