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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: Limited pelvic Lymphadenectomy; Procedure: Extended pelvic Lymphadenectomy

• Registration Number: NCT01555086
• Lead Sponsor: Association of Urologic Oncology (AUO)

Brief Summary

This study examines Limited versus extended pelvic lymphadenectomy.

Detailed Description

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-14
• Study First Posted: 2012-03-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24
• Primary Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Limited pelvic Lymphadenectomy	Limited pelvic Lymphadenectomy	-
Extended pelvic Lymphadenectomy	Extended pelvic Lymphadenectomy	-

Primary Outcome Measures

Name	Time	Method
PSA-progress	5 years	3-monthly Follow-up with PSA-measurement in blood

Secondary Outcome Measures

Name	Time	Method
Comparison of overall survival	5 years	Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy
Comparison of morbidity	5 years	Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy

Trial Locations

Locations (5)

Krankenhaus Maria Hilf; 🇩🇪 Krefeld, Dießemer Bruch 80, Germany

Martiniklinik am UKE; 🇩🇪 Hamburg, Martinistraße 52, Germany

St. Antonius-Krankenhaus; 🇩🇪 Gronau, Möllenweg 22, Germany

Städtisches Klinikum Fulda; 🇩🇪 Fulda, Pacelliallee 3-5, Germany

RWTH Aachen; 🇩🇪 Aachen, Pauwelsstraße 30, Germany