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

NCT01812902 | Completed DMC

• 1 other identifier: UROUSP - 006
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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

Keywords

Prostate cancer; Prostate specific antigen; lymphadenectomy; Limited lymphadenectomy; Extended lymphadenectomy; Immunohistochemistry

Outcome Measures

Primary Outcomes (1)

• Biochemical relapse-free survival

  Five years

Secondary Outcomes (2)

• Staging

  One Month

• Cancer specific survival

  10 years

Other Outcomes (2)

• Spread pattern of prostate cancer

  One Month

• Metastasis free survival

  Ten years

Study Arms (2)

Extended LND

EXPERIMENTAL

Radical Prostatectomy with extended lymphadenectomy

Procedure: Radical Prostatectomy

Limited LND

ACTIVE COMPARATOR

Radical Prostatectomy with Limited lymphadenectomy

Procedure: Radical Prostatectomy

Interventions

Radical Prostatectomy PROCEDURE

Extended LND; Limited LND

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Cancer do Estado de São Paulo

São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• 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

  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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Phd

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 18, 2013
• Study Start: February 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

BR (1)