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.
- 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
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
1. PSA-progress (Time Frame - 5 years): 3-monthly Follow-up with PSA-measurement in blood
Secondary outcome:
1. Comparison of overall survival (Time Frame - 5 years): Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy
2. Comparison of morbidity (Time Frame - 5 years): Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy
