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

Completed

• Conditions: Secondary Malignant Neoplasm of Lymph Node; Prostatic Neoplasms
• Interventions: Procedure: Radical Prostatectomy; Procedure: Extended Lymphadenectomy

• Registration Number: NCT02156414
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 135

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinically Localized Prostatic Neoplasm	Radical Prostatectomy	Radical Prostatectomy Extended Lymphadenectomy
Clinically Localized Prostatic Neoplasm	Extended Lymphadenectomy	Radical Prostatectomy Extended Lymphadenectomy

Primary Outcome Measures

Name	Time	Method
Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis	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

Name	Time	Method
The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.	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.

Trial Locations

Locations (3)

Hospital Universitario San Ignacio; 🇨🇴 Bogota, Colombia

Fundacion Cardioinfantil; 🇨🇴 Bogota, Colombia

Fundacion Hospital Santafe; 🇨🇴 Bogota, Colombia