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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended LND | Experimental | Radical Prostatectomy with extended lymphadenectomy |
|
| Limited LND | Active Comparator | Radical Prostatectomy with Limited lymphadenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical Prostatectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical relapse-free survival | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Staging | At the moment of the pathological analysis We will do immunohistochemistry to detect micro metastasis | One Month |
| Cancer specific survival | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Spread pattern of prostate cancer | One Month | |
| Metastasis free survival | Ten years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcos F Dall'Oglio, M.D. Phd | University of Sao Paulo | Study Director |
| Jean FP Lestingi, Doctor | University of Sao Paulo | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Cancer do Estado de São Paulo | São Paulo | 01246-000 | Brazil |
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| 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 | Study Chair |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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