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

NCT02156414 | Completed DMC

• 1 other identifier: 7-2013
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 3

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.

Conditions

Secondary Malignant Neoplasm of Lymph Node; Prostatic Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis

  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.

  within the first 30 days after surgery

Secondary Outcomes (1)

• The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.

  Within the first 30 days after surgery

Study Arms (1)

Clinically Localized Prostatic Neoplasm

Radical Prostatectomy Extended Lymphadenectomy

Procedure: Radical Prostatectomy; Procedure: Extended Lymphadenectomy

Interventions

Radical Prostatectomy PROCEDURE

Radical Prostatectomy

Clinically Localized Prostatic Neoplasm

Extended Lymphadenectomy PROCEDURE

Extended Lymphadenectomy

Clinically Localized Prostatic Neoplasm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with clinical localized prostate cancer who undergo a radical prostatectomy in the 3 centers. Hospital Universitario San Ignacio, Hospital Fundacion Santa fe de Bogota, Fundacion Cardioinfantil.

You may qualify if:

• 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.

You may not qualify if:

• Patients in which the standard technique of the extended lymphadenectomy could not be done and it was changed.

Sponsors & Collaborators

• Javeriana University: lead
• Hospital Universitario San Ignacio: collaborator
• Fundación Santa Fe de Bogota: collaborator
• Fundación Cardioinfantil Instituto de Cardiología: collaborator

Study Sites (3)

Fundacion Cardioinfantil

Bogotá, Bogota D.C., 110911, Colombia

Location

Fundacion Hospital Santafe

Bogotá, Bogota D.C., 110911, Colombia

Location

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., 110911, Colombia

Location

Related Publications (27)

• Heidenreich 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 BACKGROUND

• Delahunt 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 BACKGROUND

• Briganti 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 BACKGROUND

• Abdollah 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 BACKGROUND

• Abdollah 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 BACKGROUND

• Mohler 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.

  PMID: 20141676 BACKGROUND

• Thompson I, Thrasher JB, Aus G, Burnett AL, Canby-Hagino ED, Cookson MS, D'Amico AV, Dmochowski RR, Eton DT, Forman JD, Goldenberg SL, Hernandez J, Higano CS, Kraus SR, Moul JW, Tangen CM; AUA Prostate Cancer Clinical Guideline Update Panel. Guideline for the management of clinically localized prostate cancer: 2007 update. J Urol. 2007 Jun;177(6):2106-31. doi: 10.1016/j.juro.2007.03.003. No abstract available.

  PMID: 17509297 BACKGROUND

• Gacci M, Del Popolo G, Artibani W, Tubaro A, Palli D, Vittori G, Lapini A, Serni S, Carini M. Visual assessment of uroflowmetry curves: description and interpretation by urodynamists. World J Urol. 2007 Jun;25(3):333-7. doi: 10.1007/s00345-007-0165-8. Epub 2007 Apr 14.

  PMID: 17436003 BACKGROUND

• Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004. Ann Oncol. 2005 Mar;16(3):481-8. doi: 10.1093/annonc/mdi098. Epub 2005 Feb 17.

  PMID: 15718248 BACKGROUND

• Moyer VA; U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Jul 17;157(2):120-34. doi: 10.7326/0003-4819-157-2-201207170-00459.

  PMID: 22801674 BACKGROUND

• Miki J, Egawa S. The role of lymph node dissection in the management of prostate cancer. Int J Clin Oncol. 2011 Jun;16(3):195-202. doi: 10.1007/s10147-011-0245-z. Epub 2011 May 10.

  PMID: 21556799 BACKGROUND

• Wagner M, Sokoloff M, Daneshmand S. The role of pelvic lymphadenectomy for prostate cancer--therapeutic? J Urol. 2008 Feb;179(2):408-13. doi: 10.1016/j.juro.2007.09.027.

  PMID: 18076938 BACKGROUND

• Epstein JI, Allsbrook WC Jr, Amin MB, Egevad LL; ISUP Grading Committee. The 2005 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma. Am J Surg Pathol. 2005 Sep;29(9):1228-42. doi: 10.1097/01.pas.0000173646.99337.b1. No abstract available.

  PMID: 16096414 BACKGROUND

• Harnden P, Shelley MD, Coles B, Staffurth J, Mason MD. Should the Gleason grading system for prostate cancer be modified to account for high-grade tertiary components? A systematic review and meta-analysis. Lancet Oncol. 2007 May;8(5):411-9. doi: 10.1016/S1470-2045(07)70136-5.

  PMID: 17466898 BACKGROUND

• D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.

  PMID: 9749478 BACKGROUND

• D'Amico AV, Cote K, Loffredo M, Renshaw AA, Schultz D. Determinants of prostate cancer-specific survival after radiation therapy for patients with clinically localized prostate cancer. J Clin Oncol. 2002 Dec 1;20(23):4567-73. doi: 10.1200/JCO.2002.03.061.

  PMID: 12454114 BACKGROUND

• Allaf ME, Palapattu GS, Trock BJ, Carter HB, Walsh PC. Anatomical extent of lymph node dissection: impact on men with clinically localized prostate cancer. J Urol. 2004 Nov;172(5 Pt 1):1840-4. doi: 10.1097/01.ju.0000140912.45821.1d.

  PMID: 15540734 BACKGROUND

• Bader P, Burkhard FC, Markwalder R, Studer UE. Disease progression and survival of patients with positive lymph nodes after radical prostatectomy. Is there a chance of cure? J Urol. 2003 Mar;169(3):849-54. doi: 10.1097/01.ju.0000049032.38743.c7.

  PMID: 12576797 BACKGROUND

• Clark T, Parekh DJ, Cookson MS, Chang SS, Smith ER Jr, Wells N, Smith J Jr. Randomized prospective evaluation of extended versus limited lymph node dissection in patients with clinically localized prostate cancer. J Urol. 2003 Jan;169(1):145-7; discussion 147-8. doi: 10.1016/S0022-5347(05)64055-4.

  PMID: 12478123 BACKGROUND

• Briganti A, Blute ML, Eastham JH, Graefen M, Heidenreich A, Karnes JR, Montorsi F, Studer UE. Pelvic lymph node dissection in prostate cancer. Eur Urol. 2009 Jun;55(6):1251-65. doi: 10.1016/j.eururo.2009.03.012. Epub 2009 Mar 10.

  PMID: 19297079 BACKGROUND

• Heidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F; European Association of Urology. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol. 2011 Jan;59(1):61-71. doi: 10.1016/j.eururo.2010.10.039. Epub 2010 Oct 28.

  PMID: 21056534 BACKGROUND

• Cagiannos I, Karakiewicz P, Eastham JA, Ohori M, Rabbani F, Gerigk C, Reuter V, Graefen M, Hammerer PG, Erbersdobler A, Huland H, Kupelian P, Klein E, Quinn DI, Henshall SM, Grygiel JJ, Sutherland RL, Stricker PD, Morash CG, Scardino PT, Kattan MW. A preoperative nomogram identifying decreased risk of positive pelvic lymph nodes in patients with prostate cancer. J Urol. 2003 Nov;170(5):1798-803. doi: 10.1097/01.ju.0000091805.98960.13.

  PMID: 14532779 BACKGROUND

• Abdollah F, Sun M, Thuret R, Budaus L, Jeldres C, Graefen M, Briganti A, Perrotte P, Rigatti P, Montorsi F, Karakiewicz PI. Decreasing rate and extent of lymph node staging in patients undergoing radical prostatectomy may undermine the rate of diagnosis of lymph node metastases in prostate cancer. Eur Urol. 2010 Dec;58(6):882-92. doi: 10.1016/j.eururo.2010.09.029. Epub 2010 Sep 28.

  PMID: 20932637 BACKGROUND

• Bhatta-Dhar N, Reuther AM, Zippe C, Klein EA. No difference in six-year biochemical failure rates with or without pelvic lymph node dissection during radical prostatectomy in low-risk patients with localized prostate cancer. Urology. 2004 Mar;63(3):528-31. doi: 10.1016/j.urology.2003.09.064.

  PMID: 15028451 BACKGROUND

• Hyndman ME, Mullins JK, Pavlovich CP. Pelvic node dissection in prostate cancer: extended, limited, or not at all? Curr Opin Urol. 2010 May;20(3):211-7. doi: 10.1097/MOU.0b013e328338405d.

  PMID: 20224412 BACKGROUND

• Gerstenbluth RE, Seftel AD, Hampel N, Oefelein MG, Resnick MI. The accuracy of the increased prostate specific antigen level (greater than or equal to 20 ng./ml.) in predicting prostate cancer: is biopsy always required? J Urol. 2002 Nov;168(5):1990-3. doi: 10.1016/S0022-5347(05)64279-6.

  PMID: 12394692 BACKGROUND

• Brawley OW. Prostate cancer epidemiology in the United States. World J Urol. 2012 Apr;30(2):195-200. doi: 10.1007/s00345-012-0824-2. Epub 2012 Apr 5.

  PMID: 22476558 RESULT

MeSH Terms

Conditions

Lymphatic Metastasis; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• JOSE G RAMOS, MF

  Javeriana University

  PRINCIPAL INVESTIGATOR

• JUAN G CATAÑO, MD

  Javeriana University

  STUDY DIRECTOR

• LUIS G VILLARRAGA, MD

  Javeriana University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Urology Resident

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: June 5, 2014
• Study Start: March 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

CO (3)