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

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.

Conditions

• Prostate Cancer

Interventions

PROCEDURE

Radical Prostatectomy

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Marcos F Dall'Oglio, M.D. Phd · University of Sao Paulo

• Jean FP Lestingi, Doctor · University of Sao Paulo

• Jose P Junior, M.D · University of Sao Paulo

• Alexandre C Sant'Anna, M.D · University of Sao Paulo

• Rafael F Coelho, Doctor · University of Sao Paulo

• Giuliano B Guglielmetti, Doctor · University of Sao Paulo

• Juliana N Ravaninni, Doctor · University of Sao Paulo

• Daher C Chade, M.D. · University of Sao Paulo

• Matheus S Chaib, Doctor · University of Sao Paulo

• Mauricio D Cordeiro, Doctor · University of Sao Paulo

• Rodrigo R Pessoa, Doctor · University of Sao Paulo

• Luiz AA Botelho, Doctor · University of Sao Paulo

• Adriano Nesralla, M.D. · University of Sao Paulo

• Claudio B Murta, Doctor · University of Sao Paulo

• Fabio L Ortega, Doctor · University of Sao Paulo

• Daniel K Abe, M.D. · University of Sao Paulo

• Leonardo L Borges, Doctor · University of Sao Paulo

• Luiz CN Oliveira, M.D. · University of Sao Paulo

• Flavio GM Areas, Doctor · University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• Brazil

Study Locations