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

This study is currently recruiting participants. (see Contacts and Locations)
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: July 25, 2014
Last verified: March 2012
  Purpose

This study examines Limited versus extended pelvic lymphadenectomy.


Condition Intervention
Prostate Cancer
Procedure: Limited pelvic Lymphadenectomy
Procedure: Extended pelvic Lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

Resource links provided by NLM:


Further study details as provided by Association of Urogenital Oncology (AUO):

Primary Outcome Measures:
  • PSA-progress [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    3-monthly Follow-up with PSA-measurement in blood


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 500
Study Start Date: August 2011
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555086

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: Katja Jünemann    0241/80-36 596    kjuenemann@ukaachen.de   
Sponsors and Collaborators
Association of Urogenital Oncology (AUO)
  More Information

No publications provided

Responsible Party: Association of Urogenital Oncology (AUO)
ClinicalTrials.gov Identifier: NCT01555086     History of Changes
Other Study ID Numbers: AP 55/09, DRKS00003256
Study First Received: March 13, 2012
Last Updated: July 25, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Association of Urogenital 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

ClinicalTrials.gov processed this record on October 19, 2014