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

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ClinicalTrials.gov Identifier: NCT02156414
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Hospital Universitario San Ignacio
Fundación Santa Fe de Bogota
Fundación Cardioinfantil Instituto de Cardiología
Information provided by (Responsible Party):
Jose Gustavo Ramos, Javeriana University

Brief Summary:
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.

Condition or disease Intervention/treatment
Secondary Malignant Neoplasm of Lymph Node Prostatic Neoplasms Procedure: Radical Prostatectomy Procedure: Extended Lymphadenectomy

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Study Type : Observational [Patient Registry]
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Lymph Node Involvement Using Extended Pelvic Lymphadenectomy in Clinically Localized Prostate Cancer in Bogota Colombia.
Study Start Date : March 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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

Procedure: Extended Lymphadenectomy
Extended Lymphadenectomy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156414


Locations
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Colombia
Fundacion Cardioinfantil
Bogota, Colombia, 110911
Fundacion Hospital Santafe
Bogota, Colombia, 110911
Hospital Universitario San Ignacio
Bogota, Colombia, 110911
Sponsors and Collaborators
Javeriana University
Hospital Universitario San Ignacio
Fundación Santa Fe de Bogota
Fundación Cardioinfantil Instituto de Cardiología
Investigators
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Principal Investigator: JOSE G RAMOS, MF Javeriana University
Study Director: JUAN G CATAÑO, MD Javeriana University
Study Chair: LUIS G VILLARRAGA, MD Javeriana University
Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Jose Gustavo Ramos, MD, Urology Resident, Javeriana University
ClinicalTrials.gov Identifier: NCT02156414    
Other Study ID Numbers: 7-2013
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Keywords provided by Jose Gustavo Ramos, Javeriana University:
Prostatectomy
Extended Lymphadenectomy
Pelvic lymph node dissection
Prostatic Neoplasm
Prospective Studies
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases