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

March 13, 2012
March 14, 2012
August 2011
August 2017   (final data collection date for primary outcome measure)
PSA-progress [ Time Frame: 5 years ] [ Designated as safety issue: No ]
3-monthly Follow-up with PSA-measurement in blood
Same as current
Complete list of historical versions of study NCT01555086 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

This study examines Limited versus extended pelvic lymphadenectomy.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • Experimental: Limited pelvic Lymphadenectomy
    Intervention: Procedure: Limited pelvic Lymphadenectomy
  • Experimental: Extended pelvic Lymphadenectomy
    Intervention: Procedure: Extended pelvic Lymphadenectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
August 2017   (final data collection date for primary outcome measure)

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
Male
18 Years to 75 Years
No
Not Provided
Germany
 
NCT01555086
AP 55/09
Yes
Association of Urogenital Oncology (AUO)
Association of Urogenital Oncology (AUO)
Not Provided
Not Provided
Association of Urogenital Oncology (AUO)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP