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

NCT ID: NCT01812902

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2018-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Extended LND

Radical Prostatectomy with extended lymphadenectomy

Group Type: EXPERIMENTAL

Radical Prostatectomy

Intervention Type: PROCEDURE

Limited LND

Radical Prostatectomy with Limited lymphadenectomy

Group Type: ACTIVE_COMPARATOR

Radical Prostatectomy

Intervention Type: PROCEDURE

Interventions

Radical Prostatectomy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marcos Francisco Dall'Oglio

M.D. Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcos F Dall'Oglio, M.D. Phd

Role: STUDY_DIRECTOR

University of Sao Paulo

Jean FP Lestingi, Doctor

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Jose P Junior, M.D

Role: STUDY_CHAIR

University of Sao Paulo

Alexandre C Sant'Anna, M.D

Role: STUDY_CHAIR

University of Sao Paulo

Rafael F Coelho, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Giuliano B Guglielmetti, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Juliana N Ravaninni, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Daher C Chade, M.D.

Role: STUDY_CHAIR

University of Sao Paulo

Matheus S Chaib, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Mauricio D Cordeiro, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Rodrigo R Pessoa, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Luiz AA Botelho, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Adriano Nesralla, M.D.

Role: STUDY_CHAIR

University of Sao Paulo

Claudio B Murta, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Fabio L Ortega, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Daniel K Abe, M.D.

Role: STUDY_CHAIR

University of Sao Paulo

Leonardo L Borges, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Luiz CN Oliveira, M.D.

Role: STUDY_CHAIR

University of Sao Paulo

Flavio GM Areas, Doctor

Role: STUDY_CHAIR

University of Sao Paulo

Locations

Instituto do Cancer do Estado de São Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

UROUSP - 006

Identifier Type: -

Identifier Source: org_study_id