Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

Study Overview
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Brief Summary
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This study examines Limited versus extended pelvic lymphadenectomy.

Detailed Description
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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.

Official Title
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Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Limited pelvic Lymphadenectomy
* Procedure: Extended pelvic Lymphadenectomy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Limited pelvic Lymphadenectomy<br> | Procedure: Limited pelvic Lymphadenectomy<br>* approximately 10-14 lymph nodes are removed<br>* Other names: limited pelvic LA;|
| Experimental: Extended pelvic Lymphadenectomy<br> | Procedure: Extended pelvic Lymphadenectomy<br>* approximately 20 lymph nodes are removed<br>* Other names: extended pelvic LA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA-progress | 3-monthly Follow-up with PSA-measurement in blood | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of overall survival | Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy | 5 years | 
| Comparison of morbidity | Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Lymphadenectomy