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

January 23, 2017 updated by: Association of Urologic Oncology (AUO)

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

This study examines Limited versus extended pelvic lymphadenectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Axel Heidenreich, Prof. Dr.

Study Locations

  • Germany
    • Dießemer Bruch 80
      • Krefeld, Dießemer Bruch 80, Germany, 47805
        • Recruiting
        • Krankenhaus Maria Hilf
        • Contact:
    • Martinistraße 52
      • Hamburg, Martinistraße 52, Germany, 20246
    • Möllenweg 22
      • Gronau, Möllenweg 22, Germany, 48599
    • Pacelliallee 3-5
    • Pauwelsstraße 30
      • Aachen, Pauwelsstraße 30, Germany, 51074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Limited pelvic Lymphadenectomy
Procedure: Limited pelvic Lymphadenectomy
approximately 10-14 lymph nodes are removed
Other Names:
  • limited pelvic LA
Experimental: Extended pelvic Lymphadenectomy
Procedure: Extended pelvic Lymphadenectomy
approximately 20 lymph nodes are removed
Other Names:
  • extended pelvic LA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association of Urologic Oncology (AUO)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP 55/09
  • DRKS00003256 (Registry Identifier: DRKS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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