Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Secondary Malignant Neoplasm of Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extended Lymphadenectomy | Procedure | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Clinically Localized Prostatic Neoplasm
- description
- Radical Prostatectomy Extended Lymphadenectomy
- interventionNames
- Procedure: Radical Prostatectomy
- Procedure: Extended Lymphadenectomy
Primary outcomes (1)
- measure
- Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis
- timeFrame
- within the first 30 days after surgery
- description
- 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)
- measure
- The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (27)
- BACKGROUNDHeidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F. [EAU guidelines on prostate cancer. Part I: screening, diagnosis, and treatment of clinically localised disease]. Actas Urol Esp. 2011 Oct;35(9):501-14. doi: 10.1016/j.acuro.2011.04.004. Epub 2011 Jul 14. Spanish. PMID 21757259
- BACKGROUNDDelahunt B, Miller RJ, Srigley JR, Evans AJ, Samaratunga H. Gleason grading: past, present and future. Histopathology. 2012 Jan;60(1):75-86. doi: 10.1111/j.1365-2559.2011.04003.x. PMID 22212079
- BACKGROUNDBriganti A, Chun FK, Salonia A, Gallina A, Zanni G, Scattoni V, Valiquette L, Rigatti P, Montorsi F, Karakiewicz PI. Critical assessment of ideal nodal yield at pelvic lymphadenectomy to accurately diagnose prostate cancer nodal metastasis in patients undergoing radical retropubic prostatectomy. Urology. 2007 Jan;69(1):147-51. doi: 10.1016/j.urology.2006.09.008. PMID 17270638
- BACKGROUNDAbdollah F, Sun M, Suardi N, Gallina A, Capitanio U, Bianchi M, Tutolo M, Passoni N, Karakiewicz PI, Rigatti P, Montorsi F, Briganti A; National Comprehensive Cancer Network. National Comprehensive Cancer Network practice guidelines 2011: Need for more accurate recommendations for pelvic lymph node dissection in prostate cancer. J Urol. 2012 Aug;188(2):423-8. doi: 10.1016/j.juro.2012.03.129. Epub 2012 Jun 13. PMID 22698627
- BACKGROUNDAbdollah F, Sun M, Briganti A, Thuret R, Schmitges J, Gallina A, Suardi N, Capitanio U, Salonia A, Shariat SF, Perrotte P, Rigatti P, Montorsi F, Karakiewicz PI. Critical assessment of the European Association of Urology guideline indications for pelvic lymph node dissection at radical prostatectomy. BJU Int. 2011 Dec;108(11):1769-75. doi: 10.1111/j.1464-410X.2011.10204.x. Epub 2011 Apr 20. PMID 21507189
- BACKGROUNDMohler J, Bahnson RR, Boston B, Busby JE, D'Amico A, Eastham JA, Enke CA, George D, Horwitz EM, Huben RP, Kantoff P, Kawachi M, Kuettel M, Lange PH, Macvicar G, Plimack ER, Pow-Sang JM, Roach M 3rd, Rohren E, Roth BJ, Shrieve DC, Smith MR, Srinivas S, Twardowski P, Walsh PC. NCCN clinical practice guidelines in oncology: prostate cancer. J Natl Compr Canc Netw. 2010 Feb;8(2):162-200. doi: 10.6004/jnccn.2010.0012. No abstract available.