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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

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

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.

Detailed Summary:
Sponsor: Javeriana University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Javeriana University

Dates:
Date Received: May 13, 2014
Date Started: March 2013
Date Completion:
Last Updated: April 21, 2015
Last Verified: April 2015