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Clinical Trials/NCT02156414
NCT02156414CompletedNot Applicable

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

Javeriana University3 sites in 1 country135 target enrollmentStarted: March 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
135
Locations
3
Primary Endpoint
Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.(Within the first 30 days after surgery)

Investigators

Sponsor
Javeriana University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jose Gustavo Ramos

MD, Urology Resident

Javeriana University

Study Sites (3)

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