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
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Lymphadenectomy, Prostate cancer
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
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
NCT ID
NCT01555086
First Posted
March 13, 2012
Last Updated
January 23, 2017
Sponsor
Association of Urologic Oncology (AUO)
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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