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Completed

NCT Number: NCT02156414

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Fundacion Cardioinfantil, Bogotá, Bogota D.C., Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radical prostatectomy

Procedure

Radical Prostatectomy

Extended Lymphadenectomy

Procedure

Extended Lymphadenectomy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Javeriana University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LNIEPLCLPC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2014
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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