Clinical trial NCT01812902: Prospective Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
Official title: Prospective Randomized Study Comparing Extended With Limited Pelvic Lymphadenectomy in Intermediate and High Risk Prostate Cancer Patients Undergoing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Prostate specific antigen
lymphadenectomy
Limited lymphadenectomy
Extended lymphadenectomy
Immunohistochemistry
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-03-18
Enrollment: 260
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Biochemical relapse-free survival
timeFrame: Five years
Secondary outcomes:
measure: Staging
timeFrame: One Month
measure: Cancer specific survival
timeFrame: 10 years
Other outcomes:
measure: Spread pattern of prostate cancer
timeFrame: One Month
measure: Metastasis free survival
timeFrame: Ten years
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Marcos F Dall'Oglio, M.D. Phd
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Jean FP Lestingi, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Jose P Junior, M.D
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Alexandre C Sant'Anna, M.D
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Rafael F Coelho, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Giuliano B Guglielmetti, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Juliana N Ravaninni, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Daher C Chade, M.D.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Matheus S Chaib, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Mauricio D Cordeiro, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Rodrigo R Pessoa, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Luiz AA Botelho, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Adriano Nesralla, M.D.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Claudio B Murta, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Fabio L Ortega, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Daniel K Abe, M.D.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Leonardo L Borges, Doctor
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Luiz CN Oliveira, M.D.
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Flavio GM Areas, Doctor
role: STUDY_CHAIR
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