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

This study is currently recruiting participants.

Verified March 2012 by Association of Urogenital Oncology (AUO)

Sponsor:

Information provided by (Responsible Party):

Association of Urogenital Oncology (AUO)

ClinicalTrials.gov Identifier:

NCT01555086

First received: March 13, 2012

Last updated: March 14, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 13, 2012
Last Updated Date	March 14, 2012
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	August 2017 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 14, 2012)	PSA-progress [ Time Frame: 5 years ] [ Designated as safety issue: No ] 3-monthly Follow-up with PSA-measurement in blood
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01555086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 14, 2012)	Comparison of overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ] Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy Comparison of morbidity [ Time Frame: 5 years ] [ Designated as safety issue: No ] Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Official Title ^ICMJE	Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer
Intervention ^ICMJE	Procedure: Limited pelvic Lymphadenectomy approximately 10-14 lymph nodes are removed Other Name: limited pelvic LA Procedure: Extended pelvic Lymphadenectomy approximately 20 lymph nodes are removed Other Name: extended pelvic LA
Study Arm (s)	Experimental: Limited pelvic Lymphadenectomy Intervention: Procedure: Limited pelvic Lymphadenectomy Experimental: Extended pelvic Lymphadenectomy Intervention: Procedure: Extended pelvic Lymphadenectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	500
Completion Date	Not Provided
Estimated Primary Completion Date	August 2017 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01555086
Other Study ID Numbers ^ICMJE	AP 55/09
Has Data Monitoring Committee	Yes
Responsible Party	Association of Urogenital Oncology (AUO)
Study Sponsor ^ICMJE	Association of Urogenital Oncology (AUO)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Association of Urogenital Oncology (AUO)
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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