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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Limited pelvic Lymphadenectomy
Extended pelvic Lymphadenectomy
Sponsored by
Association of Urologic Oncology (AUO)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Lymphadenectomy, Prostate cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus Maria HilfRecruiting
  • Martiniklinik am UKERecruiting
  • St. Antonius-KrankenhausRecruiting
  • Städtisches Klinikum FuldaRecruiting
  • RWTH AachenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Limited pelvic Lymphadenectomy

Extended pelvic Lymphadenectomy

Arm Description

Outcomes

Primary Outcome Measures

PSA-progress
3-monthly Follow-up with PSA-measurement in blood

Secondary Outcome Measures

Comparison of overall survival
Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy
Comparison of morbidity
Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy

Full Information

First Posted
March 13, 2012
Last Updated
January 23, 2017
Sponsor
Association of Urologic Oncology (AUO)
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1. Study Identification

Unique Protocol Identification Number
NCT01555086
Brief Title
Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Acronym
SEAL
Official Title
Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association of Urologic Oncology (AUO)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Lymphadenectomy, Prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Limited pelvic Lymphadenectomy
Arm Type
Experimental
Arm Title
Extended pelvic Lymphadenectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Limited pelvic Lymphadenectomy
Other Intervention Name(s)
limited pelvic LA
Intervention Description
approximately 10-14 lymph nodes are removed
Intervention Type
Procedure
Intervention Name(s)
Extended pelvic Lymphadenectomy
Other Intervention Name(s)
extended pelvic LA
Intervention Description
approximately 20 lymph nodes are removed
Primary Outcome Measure Information:
Title
PSA-progress
Description
3-monthly Follow-up with PSA-measurement in blood
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Comparison of overall survival
Description
Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy
Time Frame
5 years
Title
Comparison of morbidity
Description
Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidrun Rexer
Email
heidrun.rexer@meckevidence.de
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Heidenreich, Prof. Dr.
Facility Information:
Facility Name
Krankenhaus Maria Hilf
City
Krefeld
State/Province
Dießemer Bruch 80
ZIP/Postal Code
47805
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Kämper
Phone
02151 / 334-5248
Email
M.Kaemper@alexianer.de
Facility Name
Martiniklinik am UKE
City
Hamburg
State/Province
Martinistraße 52
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneta Malamateniou
Phone
040/74 10 51 311
Email
malamateniou@martini-klinik.de
Facility Name
St. Antonius-Krankenhaus
City
Gronau
State/Province
Möllenweg 22
ZIP/Postal Code
48599
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Günter Gust
Phone
02562/915-77 80
Email
gust@st-antonius-gronau.de
Facility Name
Städtisches Klinikum Fulda
City
Fulda
State/Province
Pacelliallee 3-5
ZIP/Postal Code
36043
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Schieber, Dr.
Email
Matthias.Schieber@klinikum-fulda.de
Facility Name
RWTH Aachen
City
Aachen
State/Province
Pauwelsstraße 30
ZIP/Postal Code
51074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Richlowski
Phone
0241/80-35 358
Email
srichlowski@ukaachen.de

12. IPD Sharing Statement

Learn more about this trial

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

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