Secondary Malignant Neoplasm of Lymph NodeLNIEPLCLPCNCT02156414

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

An observational study of Secondary Malignant Neoplasm of Lymph Node and Prostatic Neoplasms, run by Javeriana University at 3 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Secondary Malignant Neoplasm of Lymph Node, Prostatic Neoplasms
What is being tested?: Radical Prostatectomy and Extended Lymphadenectomy
Type of treatment: Surgery or procedure
How many people: 135 participants
Where: 3 sitesColombia
Study dates: Mar 2013to Aug 2014
How long will I take part?: 1 Month
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Colombia3 sites

Fundacion Cardioinfantil
Bogotá, Bogota D.C., 110911
Fundacion Hospital Santafe
Bogotá, Bogota D.C., 110911
Hospital Universitario San Ignacio
Bogotá, Bogota D.C., 110911

Other trials in Colombia

About this study

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

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
Being tested: Radical Prostatectomy, Extended Lymphadenectomy
Keywords: Prostatectomy, Extended Lymphadenectomy, Pelvic lymph node dissection, Prostatic Neoplasm, Prospective Studies
Medical subject headings: Lymphatic Metastasis, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radical ProstatectomyProcedure or surgery
Radical Prostatectomy
Extended LymphadenectomyProcedure or surgery
Extended Lymphadenectomy

Study groups in NCT02156414
Study group	Role	What they receive
Clinically Localized Prostatic Neoplasm		Radical Prostatectomy Extended Lymphadenectomy Receives: Procedure: Radical Prostatectomy; Procedure: Extended Lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: within the first 30 days after surgery

Secondary outcomes (1)

The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before 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.
Measured: Within the first 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Aug 2014

First posted5 Jun 2014 (estimated)
Study startMar 2013
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Secondary Malignant Neoplasm of Lymph NodeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 135 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT02156414
Sponsor's protocol ID: 7-2013
Acronym: LNIEPLCLPC
Status last verified: Apr 2015
First submitted: 13 May 2014
Last updated: 22 Apr 2015
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 21757259
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.
PubMed 22212079
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.
PubMed 17270638
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.
PubMed 22698627
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.
PubMed 21507189
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.
PubMed 20141676
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.
PubMed 17509297
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.
PubMed 17436003
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.
PubMed 15718248
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.
PubMed 22801674
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.
PubMed 21556799
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.
PubMed 18076938
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.
PubMed 16096414
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.
PubMed 17466898
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.
PubMed 9749478

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lymph Node Involvement Using Extended Pelvic Lymphadenectomy in Clinically Localized Prostate Cancer in Bogota Colombia.
ClinicalTrials.gov ID: NCT02156414
Acronym / sponsor ID: LNIEPLCLPC / 7-2013
Conditions: Secondary Malignant Neoplasm of Lymph Node, Prostatic Neoplasms
Keywords: Prostatectomy, Extended Lymphadenectomy, Pelvic lymph node dissection, Prostatic Neoplasm, Prospective Studies
Study type: Observational
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Javeriana UniversityUniversity, hospital or other
Collaborators: Hospital Universitario San Ignacio, Fundación Santa Fe de Bogota, Fundación Cardioinfantil Instituto de Cardiología
Study start: Mar 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 5 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 1

Arm	Type	Receives
Clinically Localized Prostatic Neoplasm	–	Procedure: Radical Prostatectomy, Procedure: Extended LymphadenectomyRadical Prostatectomy Extended Lymphadenectomy

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radical ProstatectomyRadical Prostatectomy	Procedure or surgery	Clinically Localized Prostatic Neoplasm
Extended LymphadenectomyExtended Lymphadenectomy	Procedure or surgery	Clinically Localized Prostatic Neoplasm

Primary outcome

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.

1 secondary outcome

The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.
Time frame: Within the first 30 days after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
Background: PubMed 21757259Heidenreich 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.
Background: PubMed 22212079Delahunt 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.
Background: PubMed 17270638Briganti 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.
Background: PubMed 22698627Abdollah 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.
Background: PubMed 21507189Abdollah 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.
Background: PubMed 20141676Mohler 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.
Background: PubMed 17509297Thompson 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.
Background: PubMed 17436003Gacci 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.
Background: PubMed 15718248Boyle 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.
Background: PubMed 22801674Moyer 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.
Background: PubMed 21556799Miki 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.
Background: PubMed 18076938Wagner 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

JOSE G RAMOS, MF principal investigator

Javeriana University

JUAN G CATAÑO, MD study director

Javeriana University

LUIS G VILLARRAGA, MD study chair

Javeriana University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Secondary Malignant Neoplasm of Lymph Node and Prostatic Neoplasms, run by Javeriana University at 3 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02156414, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.