Lymph Node Involvement Using Extended Pelvic Lymphadenectomy in Clinically Localized Prostate Cancer (LNIEPLCLPC)

April 21, 2015 updated by: Jose Gustavo Ramos, Javeriana University

Lymph Node Involvement Using Extended Pelvic Lymphadenectomy in Clinically Localized Prostate Cancer in Bogota Colombia.

Prostate cancer is considered the fourth most common malignancy cancer in America. However, in Colombia the incidence is higher, and it is considered the second cause of death among men for malignance diseases. In the framework of clinical localized prostate cancer there is a controversy regarding the best predictors of risk and the best treatment options. The actual literature is discussing the possibility of underestimate the disease and actual tools are not sufficient for proper characterization. Is in this context that extended pelvic lymphadenectomy emerges as a stratification tool in prostate cancer that defines the real commitment of the disease. The investigators need to know the characteristics that the disease has on the investigators community so the investigators can generate appropriate therapeutic approach. Thus, the present prospective observational-descriptive multicenter study, want to determine in three referral centers in Bogotá Colombia , the frequency of pelvic node involvement in patients with localized clinical prostate cancer from the stratification achieved by pelvic lymphadenectomy extended.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia, 110911
        • Fundación Cardioinfantil
      • Bogota, Colombia, 110911
        • Fundacion Hospital Santafe
      • Bogota, Colombia, 110911
        • Hospital Universitario San Ignacio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Patients with clinical localized prostate cancer who undergo a radical prostatectomy in the 3 centers. Hospital Universitario San Ignacio, Hospital Fundacion Santa fe de Bogota, Fundacion Cardioinfantil.

Description

Inclusion Criteria:

  • Patients with clinical localized prostate cancer
  • Clinical stage: cT1-cT2-, N0-Nx, M0-Mx
  • Patients who undergo radical prostatectomy and extended lymphadenectomy in one of the 3 centers of reference.

Exclusion Criteria:

  • Patients in which the standard technique of the extended lymphadenectomy could not be done and it was changed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinically Localized Prostatic Neoplasm
Radical Prostatectomy Extended Lymphadenectomy
Procedure: Radical Prostatectomy
Radical Prostatectomy
Procedure: Extended Lymphadenectomy
Extended Lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis
Time Frame: within the first 30 days after surgery
After extended pelvic lymphadenectomy the nodes are classified in ilio-obturator nodes and internal iliaca nodes. Then those nodes are send to the pathology department of the each center, and by the histopathology analysis, the pathologist determine which nodes are compromised. With the histopathology result, the investigators report de nodal involvement.
within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.
Time Frame: Within the first 30 days after surgery
After radical prostatectomy the specimen (prostate) is send to the pathology department of each center, and by the histopathology analysis, the pathologist determine the gleason score. Then the investigators compare this result to the one achieved in the biopsy result, and determine if there was a oncologic substaging related to the gleason score.
Within the first 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javeriana University

Collaborators

Hospital Universitario San Ignacio
Fundación Santa Fe de Bogota
Fundación Cardioinfantil Instituto de Cardiología

Investigators

  • Principal Investigator: JOSE G RAMOS, MF, Javeriana University
  • Study Director: JUAN G CATAÑO, MD, Javeriana University
  • Study Chair: LUIS G VILLARRAGA, MD, Javeriana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (ESTIMATE)

June 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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