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 choice. This study shell show if one method is more effective than the other.
Age
18–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
