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Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy (LFD)

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ClinicalTrials.gov Identifier: NCT01812902
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marcos Francisco Dall'Oglio, University of Sao Paulo

Brief Summary:
Prostate cancer is currently the second most common cause of cancer death in men in Western countries. Lymphadenectomy is the gold standard procedure for staging pelvic lymph node and is classically indicated in intermediate and high risk prostate cancer patients and is held at the same time of prostatectomy. A traditionally pelvic lymphadenectomy covers the obturator chain bilaterally. Recently, some studies have demonstrated the existence of lymph node involvement outside the traditional boundaries of classical lymphadenectomy, recommending therefore extended dissection; this also includes the external / internal / common iliac chains and presacral. Thus lymphadenectomy, according to these authors, would also has a therapeutic role, besides helping in better staging. Although some retrospective studies report an association between lymphadenectomy and tumor progression, the exact impact of extended lymphadenectomy in oncological outcome of patients with prostate cancer is not clearly established, mainly by lack of prospective randomized studies on the subject . The study objectives are to compare the oncologic results of extended lymphadenectomy versus limited in order to elucidate the role of extended dissection in lymph node staging and results of treatment in terms of increased tumor cure. The investigators also intend to identify patients who may benefit from oncologically extended procedure. To do this, the investigators will evaluate prospectively patients diagnosed with prostate cancer at intermediate or high risk indicating lymphadenectomy and radical prostatectomy. These patients will be randomized to the extended versus limited lymphadenectomy and the investigators will compare the lymph node metastasis and pattern of spread of prostate cancer, as well as biochemical relapse-free survival, freedom from progression to metastasis and cancer-specific survival.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Radical Prostatectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prospective Randomized Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
Study Start Date : February 2012
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Extended LND
Radical Prostatectomy with extended lymphadenectomy
Procedure: Radical Prostatectomy
Active Comparator: Limited LND
Radical Prostatectomy with Limited lymphadenectomy
Procedure: Radical Prostatectomy



Primary Outcome Measures :
  1. Biochemical relapse-free survival [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. Staging [ Time Frame: One Month ]
    At the moment of the pathological analysis We will do immunohistochemistry to detect micro metastasis

  2. Cancer specific survival [ Time Frame: 10 years ]

Other Outcome Measures:
  1. Spread pattern of prostate cancer [ Time Frame: One Month ]
  2. Metastasis free survival [ Time Frame: Ten years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate Cancer patients with intermediate or high risk and with indication of radical prostatectomy and LND
  • Absence of bone metastasis or other organ imaging test (MRI or scintigraphy)
  • Absence of hormone treatment
  • Absence of radiotherapy
  • Signing an informed consent
  • Availability and adequacy of lymph node tissue samples to perform the immunohistochemical

Exclusion Criteria:

  • Life expectancy less than 10 years
  • Absence of clinical conditions for the procedure
  • Laparoscopic or perineal surgery
  • Presence of bone or visceral metastasis
  • Neoadjuvant treatment
  • Another malignant neoplasia
  • Prior abdominal or pelvic surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812902


Locations
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Brazil
Instituto do Cancer do Estado de São Paulo
São Paulo, Brazil, 01246-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Director: Marcos F Dall'Oglio, M.D. Phd University of Sao Paulo
Principal Investigator: Jean FP Lestingi, Doctor University of Sao Paulo
Study Chair: Jose P Junior, M.D University of Sao Paulo
Study Chair: Alexandre C Sant'Anna, M.D University of Sao Paulo
Study Chair: Rafael F Coelho, Doctor University of Sao Paulo
Study Chair: Giuliano B Guglielmetti, Doctor University of Sao Paulo
Study Chair: Juliana N Ravaninni, Doctor University of Sao Paulo
Study Chair: Daher C Chade, M.D. University of Sao Paulo
Study Chair: Matheus S Chaib, Doctor University of Sao Paulo
Study Chair: Mauricio D Cordeiro, Doctor University of Sao Paulo
Study Chair: Rodrigo R Pessoa, Doctor University of Sao Paulo
Study Chair: Luiz AA Botelho, Doctor University of Sao Paulo
Study Chair: Adriano Nesralla, M.D. University of Sao Paulo
Study Chair: Claudio B Murta, Doctor University of Sao Paulo
Study Chair: Fabio L Ortega, Doctor University of Sao Paulo
Study Chair: Daniel K Abe, M.D. University of Sao Paulo
Study Chair: Leonardo L Borges, Doctor University of Sao Paulo
Study Chair: Luiz CN Oliveira, M.D. University of Sao Paulo
Study Chair: Flavio GM Areas, Doctor University of Sao Paulo

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Responsible Party: Marcos Francisco Dall'Oglio, M.D. Phd, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01812902     History of Changes
Other Study ID Numbers: UROUSP - 006
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Marcos Francisco Dall'Oglio, University of Sao Paulo:
Prostate cancer
Prostate specific antigen
lymphadenectomy
Limited lymphadenectomy
Extended lymphadenectomy
Immunohistochemistry

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases