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

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ClinicalTrials.gov Identifier: NCT01555086
Recruitment Status : Recruiting
First Posted : March 15, 2012
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Association of Urologic Oncology (AUO)

Brief Summary:
This study examines Limited versus extended pelvic lymphadenectomy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Limited pelvic Lymphadenectomy Procedure: Extended pelvic Lymphadenectomy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Study Start Date : August 2011
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Limited pelvic Lymphadenectomy Procedure: Limited pelvic Lymphadenectomy
approximately 10-14 lymph nodes are removed
Other Name: limited pelvic LA

Experimental: Extended pelvic Lymphadenectomy Procedure: Extended pelvic Lymphadenectomy
approximately 20 lymph nodes are removed
Other Name: extended pelvic LA




Primary Outcome Measures :
  1. PSA-progress [ Time Frame: 5 years ]
    3-monthly Follow-up with PSA-measurement in blood


Secondary Outcome Measures :
  1. Comparison of overall survival [ Time Frame: 5 years ]
    Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy

  2. Comparison of morbidity [ Time Frame: 5 years ]
    Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555086


Contacts
Contact: Heidrun Rexer heidrun.rexer@meckevidence.de
Contact: Axel Heidenreich, Prof. Dr.

Locations
Germany
Krankenhaus Maria Hilf Recruiting
Krefeld, Dießemer Bruch 80, Germany, 47805
Contact: Michel Kämper    02151 / 334-5248    M.Kaemper@alexianer.de   
Martiniklinik am UKE Recruiting
Hamburg, Martinistraße 52, Germany, 20246
Contact: Anneta Malamateniou    040/74 10 51 311    malamateniou@martini-klinik.de   
St. Antonius-Krankenhaus Recruiting
Gronau, Möllenweg 22, Germany, 48599
Contact: Günter Gust    02562/915-77 80    gust@st-antonius-gronau.de   
Städtisches Klinikum Fulda Recruiting
Fulda, Pacelliallee 3-5, Germany, 36043
Contact: Matthias Schieber, Dr.       Matthias.Schieber@klinikum-fulda.de   
RWTH Aachen Recruiting
Aachen, Pauwelsstraße 30, Germany, 51074
Contact: Sandra Richlowski    0241/80-35 358    srichlowski@ukaachen.de   
Sponsors and Collaborators
Association of Urologic Oncology (AUO)

Responsible Party: Association of Urologic Oncology (AUO)
ClinicalTrials.gov Identifier: NCT01555086     History of Changes
Other Study ID Numbers: AP 55/09
DRKS00003256 ( Registry Identifier: DRKS )
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Keywords provided by Association of Urologic Oncology (AUO):
Lymphadenectomy
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases