NCT01555086

Brief Summary

This study examines Limited versus extended pelvic lymphadenectomy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable prostate-cancer

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

6 years

First QC Date

March 13, 2012

Last Update Submit

January 23, 2017

Conditions

Prostate Cancer

Keywords

LymphadenectomyProstate cancer

Outcome Measures

Primary Outcomes (1)

  • PSA-progress

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

    5 years

Secondary Outcomes (2)

  • Comparison of overall survival

    5 years

  • Comparison of morbidity

    5 years

Study Arms (2)

Limited pelvic Lymphadenectomy

EXPERIMENTAL
Procedure: Limited pelvic Lymphadenectomy

Extended pelvic Lymphadenectomy

EXPERIMENTAL
Procedure: Extended pelvic Lymphadenectomy

Interventions

Limited pelvic LymphadenectomyPROCEDURE

approximately 10-14 lymph nodes are removed

Also known as: limited pelvic LA
Limited pelvic Lymphadenectomy
Extended pelvic LymphadenectomyPROCEDURE

approximately 20 lymph nodes are removed

Also known as: extended pelvic LA
Extended pelvic Lymphadenectomy

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Heidrun Rexer

CONTACT

heidrun.rexer@meckevidence.de

Axel Heidenreich, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 15, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2017

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

DE(5)