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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02156414

Acronym

LNIEPLCLPC

Enrollment

135

Registered

2014-06-05

Start date

2013-03-31

Completion date

2014-08-31

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms, Secondary Malignant Neoplasm of Lymph Node

Keywords

Prostatectomy, Extended Lymphadenectomy, Pelvic lymph node dissection, Prostatic Neoplasm, Prospective Studies

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.

Interventions

PROCEDURERadical Prostatectomy

Radical Prostatectomy

PROCEDUREExtended Lymphadenectomy

Extended Lymphadenectomy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026