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Status unknownNCT01555086SEALUpdated Jan 24, 2017

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

An interventional study of Limited pelvic Lymphadenectomy and Extended pelvic Lymphadenectomy in Prostate Cancer, sponsored by Association of Urologic Oncology (AUO). Status unknown at 5 sites in Germany. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-01-24.

Sponsored by Association of Urologic Oncology (AUO) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study summary

This study examines Limited versus extended pelvic lymphadenectomy.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Lymphadenectomy
  • Prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 500 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Association of Urologic Oncology (AUO) is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    Limited pelvic Lymphadenectomy

    Procedure: Limited pelvic Lymphadenectomy

  • Experimental
    Extended pelvic Lymphadenectomy

    Procedure: Extended pelvic Lymphadenectomy

Interventions

  • ProcedureLimited pelvic Lymphadenectomy

    approximately 10-14 lymph nodes are removed

    Also known as: limited pelvic LA

  • ProcedureExtended pelvic Lymphadenectomy

    approximately 20 lymph nodes are removed

    Also known as: extended pelvic LA

06

What researchers measure

Primary outcomes

  1. PSA-progress

    3-monthly Follow-up with PSA-measurement in blood

    Time frame: 5 years

Secondary outcomes

  1. Comparison of overall survival

    Comparison of overall survival after limited versus extended lymphadenectomy after prostatectomy

    Time frame: 5 years

  2. Comparison of morbidity

    Comparison of morbidity after limited versus extended lymphadenectomy after prostatectomy

    Time frame: 5 years

07

Study locations

5 of 5 sites recruiting
  • Krankenhaus Maria Hilf
    Krefeld, Dießemer Bruch 80 47805, Germany
    Recruiting
  • Martiniklinik am UKE
    Hamburg, Martinistraße 52 20246, Germany
    Recruiting
  • St. Antonius-Krankenhaus
    Gronau, Möllenweg 22 48599, Germany
    Recruiting
  • Städtisches Klinikum Fulda
    Fulda, Pacelliallee 3-5 36043, Germany
    Recruiting
  • RWTH Aachen
    Aachen, Pauwelsstraße 30 51074, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01555086
Lead sponsor
Association of Urologic Oncology (AUO)
Responsible party
Sponsor
First posted
Mar 15, 2012
Start date
Aug 2011
Primary completion
Aug 2017 (estimated)
Last update
Jan 24, 2017

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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